ClinicalTrials.gov
History of Changes for Study: NCT04713553
A Phase 3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of Multiple Production Lots and Dose Levels of BNT162b2 RNA-Based COVID-19 Vaccines Against COVID-19 in Healthy Participants
Latest version (submitted November 30, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 15, 2021 None (earliest Version on record)
2 February 9, 2021 Study Status, Eligibility, Outcome Measures, Arms and Interventions, Study Identification, Contacts/Locations, Study Design and Study Description
3 February 23, 2021 Recruitment Status, Study Status and Contacts/Locations
4 March 23, 2021 Study Status and Contacts/Locations
5 May 17, 2021 Study Status and Contacts/Locations
6 June 9, 2021 Outcome Measures, Arms and Interventions, Study Status, Study Identification, Eligibility, Conditions and Study Description
7 August 4, 2021 Recruitment Status, Study Status, Contacts/Locations and Study Design
8 February 17, 2022 IPDSharing and Study Status
9 July 18, 2022
Quality Control Review has not concluded Returned: August 12, 2022
Outcome Measures, Study Status, Document Section, Contacts/Locations and Study Design
10 November 30, 2022 Outcome Measures, Study Status, More Information, Adverse Events and Baseline Characteristics
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Study NCT04713553
Submitted Date:  July 18, 2022 (v9)
Quality Control Review Has Not Concluded

Note: The results information displayed below has not completed the quality control (QC) review process. ClinicalTrials.gov must post results information for applicable clinical trials (ACTs) within 30 days of submission, even if the submission has not completed the QC review process. The study sponsor or investigator is responsible for ensuring the results information meets the QC review criteria.

This submission includes brief standardized QC review comments added by the National Library of Medicine (NLM). These comments indicate the location of apparent errors, deficiencies, or inconsistencies. For more information, see the Final Rule (42 CFR Part 11) Information page.
Open or close this module Study Identification
Unique Protocol ID: C4591017
Brief Title: A Phase 3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of Multiple Production Lots and Dose Levels of BNT162b2 RNA-Based COVID-19 Vaccines Against COVID-19 in Healthy Participants
Official Title: A PHASE 3, RANDOMIZED, OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MULTIPLE PRODUCTION LOTS AND DOSE LEVELS OF THE VACCINE CANDIDATE BNT162b2 AGAINST COVID-19 IN HEALTHY PARTICIPANTS 12 THROUGH 50 YEARS OF AGE AND THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF BNT162b2 RNA-BASED COVID-19 VACCINE CANDIDATES AS A BOOSTER DOSE IN HEALTHY PARTICIPANTS 18 THROUGH 50 YEARS OF AGE
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2022
Overall Status: Completed
Study Start: February 15, 2021
Primary Completion: July 22, 2021 [Actual]
Study Completion: July 22, 2021 [Actual]
First Submitted: January 15, 2021
First Submitted that
Met QC Criteria:		 January 15, 2021
First Posted: January 19, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
Last Update Posted: August 15, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: BioNTech SE
Responsible Party: Sponsor
Collaborators: Pfizer
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary:

This is a Phase 3, randomized, observer-blind study in healthy individuals.

The primary study will evaluate the safety, tolerability, and immunogenicity of the SARS-CoV-2 RNA vaccine candidate (BNT162b2):

  • As a 30-microgram dose, administered from 1 of 4 manufacturing lots (batches)
  • As a 20-microgram dose, administered from 1 of the manufacturing lots
  • As a 2-dose (separated by 21 days) schedule
  • In people 12 through 50 years of age

The booster study will evaluate the safety, tolerability, and immunogenicity of 2 SARS-CoV-2 RNA vaccine candidates (BNT162b2 and BNT162b2.B.1.351):

  • Each as a 30-microgram dose
  • Each as a 1-dose booster vaccine, administered approximately 3 months after Dose 2
  • In people 18 through 50 years of age
Detailed Description:
Open or close this module Conditions
Conditions: SARS-CoV-2 Infection
COVID-19
Keywords: COVID-19
Coronavirus
Vaccine
SARS-CoV-2
RNA Vaccine
BNT162b2
BNT162B2.1.B.351
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 7
Masking: Triple (Participant, Care Provider, Investigator)
Allocation: Randomized
Enrollment: 1574 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Arm 1
30-microgram dose of US manufactured drug substance (Lot 1)
 Biological: BNT162b2
Intramuscular injection
Experimental: Arm 2
30-microgram dose of US manufactured drug substance (Lot 2)
 Biological: BNT162b2
Intramuscular injection
Experimental: Arm 3
30-microgram dose of US manufactured drug substance (Lot 3)
 Biological: BNT162b2
Intramuscular injection
Experimental: Arm 4
30-microgram dose of EU manufactured drug substance (Lot 4)
 Biological: BNT162b2
Intramuscular injection
Experimental: Arm 5
20-microgram dose of US manufactured drug substance (corresponding to Arm 1, 2 or 3 lot)
 Biological: BNT162b2
Intramuscular injection
Experimental: Booster 1: BNT162b2
30-microgram dose
 Biological: BNT162b2
Intramuscular injection
Experimental: Booster 2: BNT162b2.B.1.351
30-microgram dose
 Biological: BNT162b2.B.1.351
Intramuscular injection
Open or close this module Outcome Measures
[See Results Section.]
Primary Outcome Measures:
1. Geometric Mean Ratios (GMRs) of Full-Length S-Binding Immunoglobulin G (IgG) Concentrations Between Individual US Lots 1, 2, and 3 at 1 Month After Dose 2: Primary Study
[ Time Frame: 1 Month after Dose 2 ]

Geometric mean concentration of full-length S-binding IgG level for individual US lots (US lots 1, 2, and 3) was determined and reported in the descriptive section. Assay results below the lower limit of quantitation (LLOQ) were set to 0.5*LLOQ. GMRs were reported in the statistical analysis section and was calculated as ratio of Geometric Mean Concentrations (GMCs) of individual US Lots BNT162b2 30 mcg: US Lot 1, BNT162b2 30 mcg: US Lot 2 and BNT162b2 30 mcg: US Lot 3.
2. Geometric Mean Ratios (GMRs) of Full-Length S-Binding IgG Concentrations Between EU Lot and Pooled US Lots at 1 Month After Dose 2: Primary Study
[ Time Frame: 1 Month after Dose 2 ]

Geometric mean concentration of full-length S-binding IgG level for EU lot and pooled US lots (BNT162b2 30 mcg: US Lot 1, BNT162b2 30 mcg: US Lot 2 and BNT162b2 30 mcg: US Lot 3 reporting arm) were determined and reported in the descriptive section. Assay results below the LLOQ were set to 0.5*LLOQ. GMRs were reported in the statistical analysis section and was calculated as ratios of GMCs of BNT162b2 30 mcg: EU Lot and pooled US Lots (BNT162b2 30 mcg: US Lot 1, BNT162b2 30 mcg: US Lot 2 and BNT162b2 30 mcg: US Lot 3 reporting arm).
3. Geometric Mean Ratios (GMRs) of SARS-CoV-2 Neutralizing Titers Between 20-microgram Dose and 30-microgram Dose at 1 Month After Dose 2: Primary Study
[ Time Frame: 1 Month after Dose 2 ]

GMRs were calculated by exponentiating the mean difference of logarithmically transformed assay results between 2 vaccine groups. Assay results below the LLOQ were set to 0.5*LLOQ.

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
4. Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Primary Study
[ Time Frame: Within 7 days after Dose 1 ]

Local reactions were collected by the participant using an electronic diary. Local reactions included redness, swelling, and pain at injection site after Dose 1. Redness, swelling, and pain at injection site after Dose 1 were reported.
5. Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Primary Study
[ Time Frame: Within 7 days after Dose 2 ]

Local reactions were collected by the participant using an electronic diary. Local reactions included redness, swelling, and pain at injection site after Dose 2. Redness, swelling, and pain at injection site after Dose 2 were reported.
6. Percentage of Participants With Local Reactions Within 7 Days After Any Dose: Primary Study
[ Time Frame: Within 7 days after any dose ]

Local reactions were collected by the participant using an electronic diary. Local reactions included redness, swelling, and pain at injection site after each vaccination. Redness, swelling, and pain at injection site after any dose were reported.
7. Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Booster Study
[ Time Frame: Within 7 days after Dose 3 ]

Local reactions were collected by the participant using an electronic diary. Local reactions included redness, swelling, and pain at injection site after Dose 3. Redness, swelling, and pain at injection site after Dose 3 were reported.
8. Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study
[ Time Frame: Within 7 days after Dose 1 ]

Systemic events were reported using an electronic diary. Fever was defined as temperature >=38.0 degree Celsius (C) and categorized as >=38.0 to 38.4 C; >38.4 to 38.9 C; >38.9 to 40.0 C; >40.0 C. Systemic events including fever, fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain, vomiting, diarrhea, and use of antipyretic/analgesic medication after Dose 1 were reported.
9. Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study
[ Time Frame: Within 7 days after Dose 2 ]

Systemic events were reported using an electronic diary. Fever was defined as temperature >=38.0 C and categorized as >=38.0 to 38.4 C; >38.4 to 38.9 C; >38.9 to 40.0 C; >40.0 C. Systemic events including fever, fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain, vomiting, diarrhea, and use of antipyretic/analgesic medication after Dose 2 were reported.
10. Percentage of Participants With Systemic Events Within 7 Days After Any Dose: Primary Study
[ Time Frame: Within 7 days after any dose ]

Systemic events were reported using an electronic diary. Fever was defined as temperature >=38.0 C and categorized as >=38.0 to 38.4 C; >38.4 to 38.9 C; >38.9 to 40.0 C; >40.0 C. Systemic events including fever, fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain, vomiting, diarrhea, and use of antipyretic/analgesic medication after any dose were reported.
11. Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Booster Study
[ Time Frame: Within 7 days after Dose 3 ]

Systemic events were reported using an electronic diary. Fever was defined as temperature >=38.0 C and categorized as >=38.0 to 38.4 C; >38.4 to 38.9 C; >38.9 to 40.0 C; >40.0 C. Systemic events including fever, fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain, vomiting, diarrhea, and use of antipyretic/analgesic medication after Dose 3 were reported.
12. Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 2: Primary Study
[ Time Frame: Day 1 of Dose 1 up to 1 Month after Dose 2 (for a maximum of 2 months) ]

An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event.
13. Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Dose 3 to 1 Month After Dose 3: Booster Study
[ Time Frame: From Dose 3 to 1 Month after Dose 3 (for a maximum of 35 days) ]

An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event.
14. Geometric Mean Titers (GMTs) of SARS-CoV-2 Reference-strain at Baseline: Booster Study
[ Time Frame: Baseline (prior to Dose 1 of Primary study) ]

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
15. Geometric Mean Titers (GMTs) of SARS-CoV-2 Reference-strain 1 Month After Dose 2: Booster Study
[ Time Frame: 1 Month after Dose 2 of primary study ]

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
16. Geometric Mean Titers (GMTs) of SARS-CoV-2 Reference-strain Before Dose 3: Booster Study
[ Time Frame: Before Dose 3 ]

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
17. Geometric Mean Titers (GMTs) of SARS-CoV-2 Reference-strain 1 Week After Dose 3: Booster Study
[ Time Frame: 1 Week after Dose 3 ]

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
18. Geometric Mean Titers (GMTs) of SARS-CoV-2 Reference-strain 1 Month After Dose 3: Booster Study
[ Time Frame: 1 Month after Dose 3 ]

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
19. Geometric Mean Titers (GMTs) of SARS-CoV-2 B.1.351-strain at Baseline: Booster Study
[ Time Frame: Baseline (prior to Dose 1 of Primary study) ]

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
20. Geometric Mean Titers (GMTs) of SARS-CoV-2 B.1.351-strain 1 Month After Dose 2: Booster Study
[ Time Frame: 1 Month after Dose 2 of primary study ]

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
21. Geometric Mean Titers (GMTs) of SARS-CoV-2 B.1.351-strain Before Dose 3: Booster Study
[ Time Frame: Before Dose 3 ]

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
22. Geometric Mean Titers (GMTs) of SARS-CoV-2 B.1.351-strain 1 Week After Dose 3: Booster Study
[ Time Frame: 1 Week after Dose 3 ]

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
23. Geometric Mean Titers (GMTs) of SARS-CoV-2 B.1.351-strain 1 Month After Dose 3: Booster Study
[ Time Frame: 1 Month after Dose 3 ]

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
24. Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels at Baseline: Booster Study
[ Time Frame: Baseline (prior to Dose 1 of Primary study) ]

GMCs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
25. Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels 1 Month After Dose 2: Booster Study
[ Time Frame: 1 Month after Dose 2 of primary study ]

GMCs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
26. Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels Before Dose 3: Booster Study
[ Time Frame: Before Dose 3 ]

GMCs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
27. Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels 1 Week After Dose 3: Booster Study
[ Time Frame: 1 Week after Dose 3 ]

GMCs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
28. Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels 1 Month After Dose 3: Booster Study
[ Time Frame: 1 Month after Dose 3 ]

GMCs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
29. Geometric Mean Fold Rises (GMFRs) in Full-length S-binding IgG Levels From 1 Month After Dose 2 to 1 Week After Dose 3: Booster Study
[ Time Frame: From 1 Month after Dose 2 to 1 Week after Dose 3 ]

GMFRs were defined as ratios of the geometric mean concentration of IgG at 1 week after Dose 3 to the geometric mean concentration of IgG at 1 month after dose 2. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
30. Geometric Mean Fold Rises (GMFRs) in Full-length S-binding IgG Levels From 1 Month After Dose 2 to 1 Month After Dose 3: Booster Study
[ Time Frame: From 1 Month after Dose 2 to 1 Month after Dose 3 ]

GMFRs were defined as ratios of the geometric mean concentration of IgG at 1 month after Dose 3 to the geometric mean concentration of IgG at 1 month after dose 2. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
31. Geometric Mean Fold Rises (GMFRs) in Full-length S-binding IgG Levels Before Dose 3 to 1 Week After Dose 3: Booster Study
[ Time Frame: Before Dose 3 to 1 Week after Dose 3 ]

GMFRs were defined as ratios of the geometric mean concentration of IgG at 1 week after Dose 3 to the geometric mean concentration of IgG before dose 3. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
32. Geometric Mean Fold Rises (GMFRs) in Full-length S-binding IgG Levels Before Dose 3 to 1 Month After Dose 3: Booster Study
[ Time Frame: Before Dose 3 to 1 Month after Dose 3 ]

GMFRs were defined as ratios of the geometric mean concentration of IgG at 1 month after Dose 3 to the geometric mean concentration of IgG before dose 3. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
33. Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 Reference-strain From 1 Month After Dose 2 to 1 Week After Dose 3: Booster Study
[ Time Frame: From 1 Month after Dose 2 to 1 Week after Dose 3 ]

GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 reference-strain at 1 week after Dose 3 to the geometric mean titers of SARS-CoV-2 reference-strain at 1 month after dose 2. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
34. Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 Reference-strain From 1 Month After Dose 2 to 1 Month After Dose 3: Booster Study
[ Time Frame: From 1 Month after Dose 2 to 1 Month after Dose 3 ]

GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 reference-strain at 1 month after Dose 3 to the geometric mean titers of SARS-CoV-2 reference-strain at 1 month after dose 2. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
35. Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 Reference-strain Before Dose 3 to 1 Week After Dose 3: Booster Study
[ Time Frame: Before Dose 3 to 1 Week after Dose 3 ]

GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 reference-strain at 1 week after Dose 3 to the geometric mean titers of SARS-CoV-2 reference-strain before dose 3. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
36. Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 Reference-strain Before Dose 3 to 1 Month After Dose 3: Booster Study
[ Time Frame: Before Dose 3 to 1 Month after Dose 3 ]

GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 reference-strain at 1 month after Dose 3 to the geometric mean titers of SARS-CoV-2 reference-strain before dose 3. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
37. Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 B.1.351-strain From 1 Month After Dose 2 to 1 Week After Dose 3: Booster Study
[ Time Frame: From 1 Month after Dose 2 to 1 Week after Dose 3 ]

GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 B.1.351-strain at 1 week after Dose 3 to the geometric mean titers of SARS-CoV-2 B.1.351-strain at 1 month after dose 2. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
38. Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 B.1.351-strain From 1 Month After Dose 2 to 1 Month After Dose 3: Booster Study
[ Time Frame: From 1 Month after Dose 2 to 1 Month after Dose 3 ]

GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 B.1.351-strain at 1 month after Dose 3 to the geometric mean titers of SARS-CoV-2 B.1.351-strain at 1 month after dose 2. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
39. Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 B.1.351-strain Before Dose 3 to 1 Week After Dose 3: Booster Study
[ Time Frame: Before Dose 3 to 1 Week after Dose 3 ]

GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 B.1.351-strain at 1 week after Dose 3 to the geometric mean titers of SARS-CoV-2 B.1.351-strain before dose 3. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
40. Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 B.1.351-strain Before Dose 3 to 1 Month After Dose 3: Booster Study
[ Time Frame: Before Dose 3 to 1 Month after Dose 3 ]

GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 B.1.351-strain at 1 month after Dose 3 to the geometric mean titers of SARS-CoV-2 B.1.351-strain before dose 3. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
41. Percentage of Participants With Seroresponse to Reference Strain at 1 Month After Dose 2: Booster Study
[ Time Frame: 1 Month after Dose 2 ]

Seroresponse was defined as greater than equal to (>=) 4-fold increase from baseline (before Dose 1 in primary study) to the specified time point. If the baseline measurement was below LLOQ, a post vaccination measurement of >=4*LLOQ was considered a seroresponse.

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
42. Percentage of Participants With Seroresponse to Reference Strain Before Dose 3: Booster Study
[ Time Frame: Before Dose 3 ]

Seroresponse was defined as >=4-fold increase from baseline (before Dose 1 in primary study) to the specified time point. If the baseline measurement was below LLOQ, a post vaccination measurement of >=4*LLOQ was considered a seroresponse.

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
43. Percentage of Participants With Seroresponse to Reference Strain 1 Week After Dose 3: Booster Study
[ Time Frame: 1 Week after Dose 3 ]

Seroresponse was defined as >=4-fold increase from baseline (before Dose 1 in primary study) to the specified time point. If the baseline measurement was below LLOQ, a post vaccination measurement of >=4*LLOQ was considered a seroresponse.

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
44. Percentage of Participants With Seroresponse to Reference Strain 1 Month After Dose 3: Booster Study
[ Time Frame: 1 Month after Dose 3 ]

Seroresponse was defined as >=4-fold increase from baseline (before Dose 1 in primary study) to the specified time point. If the baseline measurement was below LLOQ, a post vaccination measurement of >=4*LLOQ was considered a seroresponse.

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
45. Percentage of Participants With Seroresponse to B.1.351 Variant Strain at 1 Month After Dose 2: Booster Study
[ Time Frame: 1 Month after Dose 2 ]

Seroresponse was defined as >=4-fold increase from baseline (before Dose 1 in primary study) to the specified time point. If the baseline measurement was below LLOQ, a post vaccination measurement of >=4*LLOQ was considered a seroresponse.

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
46. Percentage of Participants With Seroresponse to B.1.351 Variant Strain Before Dose 3: Booster Study
[ Time Frame: Before Dose 3 ]

Seroresponse was defined as >=4-fold increase from baseline (before Dose 1 in primary study) to the specified time point. If the baseline measurement was below LLOQ, a post vaccination measurement of >=4*LLOQ was considered a seroresponse.

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
47. Percentage of Participants With Seroresponse to B.1.351 Variant Strain 1 Week After Dose 3: Booster Study
[ Time Frame: 1 Week after Dose 3 ]

Seroresponse was defined as >=4-fold increase from baseline (before Dose 1 in primary study) to the specified time point. If the baseline measurement was below LLOQ, a post vaccination measurement of >=4*LLOQ was considered a seroresponse.

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
48. Percentage of Participants With Seroresponse to B.1.351 Variant Strain 1 Month After Dose 3: Booster Study
[ Time Frame: 1 Month after Dose 3 ]

Seroresponse was defined as >=4-fold increase from baseline (before Dose 1 in primary study) to the specified time point. If the baseline measurement was below LLOQ, a post vaccination measurement of >=4*LLOQ was considered a seroresponse.

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
Secondary Outcome Measures:
1. Geometric Mean Concentrations (GMCs) of Full-Length S-Binding IgG Levels at Baseline and 1 Month After Dose 2 for 30 mcg Dose of BNT162b2: Primary Study
[ Time Frame: Baseline (before Dose 1), 1 Month after Dose 2 ]

GMCs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5* LLOQ.
2. Geometric Mean Fold Rises (GMFRs) in Full-Length S-Binding lgG Levels From Baseline to 1 Month After Dose 2 for 30 mcg Dose of BNT162b2: Primary Study
[ Time Frame: From Baseline (before Dose 1) up to 1 Month after Dose 2 ]

GMFRs were defined as ratios of the geometric mean concentration of IgG at 1 month after Dose 2 to the geometric mean concentration of IgG at Baseline. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
3. Geometric Mean Concentrations (GMCs) of SARS-CoV-2 Neutralizing Titers at Baseline and 1 Month After Dose 2 for 20 mcg and 30 mcg Dose of BNT162b2 From US Lot 1: Primary Study
[ Time Frame: Baseline (before Dose 1), 1 Month after Dose 2 ]

GMCs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
4. Geometric Mean Fold Rises (GMFRs) in SARS-CoV-2 Neutralizing Titers From Baseline to 1 Month After Dose 2 for 20 mcg and 30 mcg Dose of BNT162b2 From US Lot 1: Primary Study
[ Time Frame: From Baseline (before Dose 1) up to 1 Month after Dose 2 ]

GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 at 1 month after Dose 2 to the geometric mean titers of SARS-CoV-2 at Baseline. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5* LLOQ.

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
Open or close this module Eligibility
Minimum Age: 12 Years
Maximum Age: 50 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  • Primary study: Male or female participants between the ages of 12 and 50 years, inclusive, at randomization.
  • Booster study: Male or female participants between the ages of 18 and 50 years, inclusive, at rerandomization.
  • Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
  • Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
  • Capable of giving personal signed informed consent/have parent(s)/legal guardian capable of giving signed informed consent.

Exclusion Criteria:

  • Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
  • Known infection with HIV, HCV, or HBV.
  • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention.
  • Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID 19.

    . Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.

  • Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
  • Women who are pregnant or breastfeeding.
  • Primary study: Previous vaccination with any coronavirus vaccine.
  • Booster study: Previous vaccination with any coronavirus vaccine outside of this study.
  • Receipt of medications intended to prevent COVID-19.
  • Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study.
  • Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study.
  • Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.
  • Previous participation in other studies involving study intervention containing lipid nanoparticles.
  • Investigator site staff or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

Additional Exclusion Criteria for the Booster study:

  • Current febrile illness (body temperature ≥100.4°F [≥38.0°C]) or other acute illness within 48 hours before study intervention administration.
  • Receipt of any seasonal or pandemic influenza vaccine within 14 days, or any other nonstudy vaccine within 28 days, before or after study intervention administration.
  • Receipt of short-term (<14 days) systemic corticosteroids. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
Open or close this module Contacts/Locations
Study Officials: Pfizer CT.gov Call Center
Study Director
Pfizer
Locations: United States, California
Kaiser Permanente Oakland
Oakland, California, United States, 94611
United States, Connecticut
Clinical Research Consulting
Milford, Connecticut, United States, 06460
United States, Florida
Indago Research & Health Center, Inc
Hialeah, Florida, United States, 33012
Research Centers of America
Hollywood, Florida, United States, 33024
Clinical Neuroscience Solutions
Orlando, Florida, United States, 32801
United States, Georgia
Clinical Research Atlanta
Stockbridge, Georgia, United States, 30281
United States, Hawaii
East-West Medical Research Institute
Honolulu, Hawaii, United States, 96814
United States, Idaho
Solaris Clinical Research
Meridian, Idaho, United States, 83646
United States, Kentucky
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, United States, 40004
United States, New Jersey
Amici Clinical Research LLC
Raritan, New Jersey, United States, 08869
United States, North Carolina
Accellacare - Wilmington
Wilmington, North Carolina, United States, 28401
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45206
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
United States, Texas
Texas Center for Drug Development, Inc.
Houston, Texas, United States, 77081
Clinical Trials of Texas, LLC
San Antonio, Texas, United States, 78229
Martin Diagnostic Clinic
Tomball, Texas, United States, 77375
United States, Utah
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, United States, 84121
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links: Description: To obtain contact information for a study center near you, click here.
Available IPD/Information:
Open or close this module Document Section
Study Protocol
Document Date: May 3, 2021
Uploaded: 07/11/2022 17:20
File Name: Prot_000.pdf
Statistical Analysis Plan
Document Date: October 15, 2021
Uploaded: 07/11/2022 17:20
File Name: SAP_001.pdf
Study Results
Open or close this module Participant Flow
Recruitment Details This study was conducted in two parts: primary study and booster study.
Pre-assignment Details Total number of participants enrolled in study and assigned to study intervention were 1574, however, only 1573 participants received study intervention.
 
Arm/Group Title BNT162b2 30 mcg: US Lot 1 BNT162b2 30 mcg: US Lot 2 BNT162b2 30 mcg: US Lot 3 BNT162b2 30 mcg: EU Lot BNT162b2 20 mcg: US Lot 1 BNT162b2 30 mcg: Booster Dose BNT162b2.B.1.351 30 mcg: Booster Dose
Arm/Group Description Participants were randomized in primary study to receive 30 microgram (mcg) intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months. Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months. Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months. Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months. Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months. Participants who received 2 doses of 30 mcg BNT162b2 vaccine in primary study from US Lot 1 were randomized to booster study to receive a single 30 mcg intramuscular dose of BNT162b2 vaccine at 3 months after second dose in the primary study. Participants were followed up for safety for up to 28-35 days after vaccination. Participants who received 2 doses of 30 mcg BNT162b2 vaccine in primary study from US Lot 1, 2 or 3 were randomized to booster study to receive a single 30 mcg intramuscular dose of BNT162b2.B.1.351 vaccine at 3 months after second dose in the primary study. Participants were followed up for safety for up to 28-35 days after vaccination.
Period Title: Primary Study (2 Months)
Started 351 352 347 173 351 0 [1] 0 [1]
Treated 351 352 346 173 351 0 0
Completed 347 346 344 171 349 0 0
Not Completed 4 6 3 2 2 0 0
Reason Not Completed
Withdrawal by Subject 2 3 0 0 1 0 0
Withdrawal by parent/guardian 0 0 0 1 0 0 0
Other 1 2 0 0 1 0 0
Lost to Follow-up 1 1 2 1 0 0 0
Inclusion criteria not met 0 0 1 0 0 0 0
[1]No participants were enrolled in this arm during the primary study.
Period Title: Booster Study (1 Month)
Started 0 0 0 0 0 31 31
Completed 0 0 0 0 0 31 31
Not Completed 0 0 0 0 0 0 0
Open or close this module Baseline Characteristics
Arm/Group TitleBNT162b2 30 mcg: US Lot 1BNT162b2 30 mcg: US Lot 2BNT162b2 30 mcg: US Lot 3BNT162b2 30 mcg: EU LotBNT162b2 20 mcg: US Lot 1Total
Arm/Group DescriptionParticipants were randomized in primary study to receive 30 microgram (mcg) intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.Total of all reporting groups
Overall Number of Baseline Participants 351 352 346 173 351 1573
Baseline Analysis Population Description
Age, Continuous
Mean (Standard Deviation)
Unit of measure: Years
Number Analyzed351 Participants352 Participants346 Participants173 Participants351 Participants1573 Participants
28.0(11.66)27.8(11.76)27.5(11.54)27.7(11.40)27.5(11.71)27.7(11.63)
Sex: Female, Male
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed351 Participants352 Participants346 Participants173 Participants351 Participants1573 Participants
Female
177
50.43%
176
50%
159
45.95%
83
47.98%
163
46.44%
758
48.19%
Male
174
49.57%
176
50%
187
54.05%
90
52.02%
188
53.56%
815
51.81%
Ethnicity (NIH/OMB)
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed351 Participants352 Participants346 Participants173 Participants351 Participants1573 Participants
Hispanic or Latino
44
12.54%
32
9.09%
55
15.9%
22
12.72%
42
11.97%
195
12.4%
Not Hispanic or Latino
306
87.18%
319
90.62%
291
84.1%
151
87.28%
309
88.03%
1376
87.48%
Unknown or Not Reported
1
0.28%
1
0.28%
0
0%
0
0%
0
0%
2
0.13%
Race (NIH/OMB)
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed351 Participants352 Participants346 Participants173 Participants351 Participants1573 Participants
American Indian or Alaska Native
0
0%
1
0.28%
1
0.29%
0
0%
3
0.85%
5
0.32%
Asian
36
10.26%
48
13.64%
40
11.56%
24
13.87%
44
12.54%
192
12.21%
Native Hawaiian or Other Pacific Islander
1
0.28%
1
0.28%
1
0.29%
0
0%
2
0.57%
5
0.32%
Black or African American
21
5.98%
16
4.55%
15
4.34%
2
1.16%
14
3.99%
68
4.32%
White
286
81.48%
280
79.55%
283
81.79%
142
82.08%
283
80.63%
1274
80.99%
More than one race
6
1.71%
5
1.42%
5
1.45%
4
2.31%
5
1.42%
25
1.59%
Unknown or Not Reported
1
0.28%
1
0.28%
1
0.29%
1
0.58%
0
0%
4
0.25%
Open or close this module Outcome Measures
1. Primary Outcome:
Title Geometric Mean Ratios (GMRs) of Full-Length S-Binding Immunoglobulin G (IgG) Concentrations Between Individual US Lots 1, 2, and 3 at 1 Month After Dose 2: Primary Study
Description Geometric mean concentration of full-length S-binding IgG level for individual US lots (US lots 1, 2, and 3) was determined and reported in the descriptive section. Assay results below the lower limit of quantitation (LLOQ) were set to 0.5*LLOQ. GMRs were reported in the statistical analysis section and was calculated as ratio of Geometric Mean Concentrations (GMCs) of individual US Lots BNT162b2 30 mcg: US Lot 1, BNT162b2 30 mcg: US Lot 2 and BNT162b2 30 mcg: US Lot 3.
Time Frame 1 Month after Dose 2
Outcome Measure Data
Analysis Population Description
Evaluable immunogenicity population: Participants who received 2 doses of vaccine in primary study, with Dose 2 received within predefined window, had at least 1 valid immunogenicity result from blood sample collected within an appropriate window at 1 month after Dose 2, were negative for both SARS-CoV-2 test (RT-PCR and N-blinding antibody) during study and had no other protocol deviations determined by clinician. Here, "N"= participants evaluable for this outcome measure.
 
Arm/Group TitleBNT162b2 30 mcg: US Lot 1BNT162b2 30 mcg: US Lot 2BNT162b2 30 mcg: US Lot 3
Arm/Group DescriptionParticipants were randomized in primary study to receive 30 microgram (mcg) intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Overall Number of Participants Analyzed324 311 310
Geometric Mean (95% Confidence Interval)
Unit of Measure: Unit per milliliter
6299.5(5835.4 to 6800.5) 6231.9(5763.7 to 6738.2) 6774.8(6264.9 to 7326.1)
Statistical Analysis 1
Statistical Analysis OverviewComparison Group SelectionBNT162b2 30 mcg: US Lot 1, BNT162b2 30 mcg: US Lot 2
Comments[Not specified]
Type of Statistical TestEquivalence
CommentsEquivalence was to be achieved if the 2-sided 95% confidence interval (CI) for GMR falls within the interval (0.67, 1.5).
Method of EstimationEstimation ParameterGeometric mean ratio
Estimated Value1.01
Confidence Interval(2-sided) 95%
0.91 to 1.13
Estimation CommentsGMRs and corresponding 2-sided 95% CIs were calculated by exponentiating difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of age and vaccine group.
Statistical Analysis 2
Statistical Analysis OverviewComparison Group SelectionBNT162b2 30 mcg: US Lot 1, BNT162b2 30 mcg: US Lot 3
Comments[Not specified]
Type of Statistical TestEquivalence
CommentsEquivalence was to be achieved if the 2-sided 95% CI for GMR falls within the interval (0.67, 1.5).
Method of EstimationEstimation ParameterGeometric mean ratio
Estimated Value0.93
Confidence Interval(2-sided) 95%
0.83 to 1.04
Estimation CommentsGMRs and corresponding 2-sided 95% CIs were calculated by exponentiating difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of age and vaccine group.
Statistical Analysis 3
Statistical Analysis OverviewComparison Group SelectionBNT162b2 30 mcg: US Lot 2, BNT162b2 30 mcg: US Lot 3
Comments[Not specified]
Type of Statistical TestEquivalence
CommentsEquivalence was to be achieved if the 2-sided 95% CI for GMR falls within the interval (0.67, 1.5).
Method of EstimationEstimation ParameterGeometric mean ratio
Estimated Value0.92
Confidence Interval(2-sided) 95%
0.82 to 1.03
Estimation CommentsGMRs and corresponding 2-sided 95% CIs were calculated by exponentiating difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of age and vaccine group.
2. Primary Outcome:
Title Geometric Mean Ratios (GMRs) of Full-Length S-Binding IgG Concentrations Between EU Lot and Pooled US Lots at 1 Month After Dose 2: Primary Study
Description Geometric mean concentration of full-length S-binding IgG level for EU lot and pooled US lots (BNT162b2 30 mcg: US Lot 1, BNT162b2 30 mcg: US Lot 2 and BNT162b2 30 mcg: US Lot 3 reporting arm) were determined and reported in the descriptive section. Assay results below the LLOQ were set to 0.5*LLOQ. GMRs were reported in the statistical analysis section and was calculated as ratios of GMCs of BNT162b2 30 mcg: EU Lot and pooled US Lots (BNT162b2 30 mcg: US Lot 1, BNT162b2 30 mcg: US Lot 2 and BNT162b2 30 mcg: US Lot 3 reporting arm).
Time Frame 1 Month after Dose 2
Outcome Measure Data
Analysis Population Description
Evaluable immunogenicity population: Participants who received 2 doses of vaccine in primary study, with Dose 2 received within predefined window, had at least 1 valid immunogenicity result from blood sample collected within an appropriate window at 1 month after Dose 2, were negative for both SARS-CoV-2 test (RT-PCR and N-blinding antibody) during study and had no other protocol deviations determined by clinician. Here, "N"= participants evaluable for this outcome measure.
 
Arm/Group TitleBNT162b2 30 mcg: EU LotPooled US Lots
Arm/Group DescriptionParticipants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.Participants randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 1 + US Lot 2 + US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Overall Number of Participants Analyzed160 945
Geometric Mean (95% Confidence Interval)
Unit of Measure: Unit per milliliter
6098.6(5474.7 to 6793.7) 6428.8(6149.5 to 6720.7)
Statistical Analysis 1
Statistical Analysis OverviewComparison Group SelectionBNT162b2 30 mcg: EU Lot, Pooled US Lots
Comments[Not specified]
Type of Statistical TestEquivalence
CommentsEquivalence was to be achieved if the 2-sided 95% CI for GMR falls within the interval (0.67, 1.5).
Method of EstimationEstimation ParameterGeometric mean ratio
Estimated Value0.95
Confidence Interval(2-sided) 95%
0.84 to 1.07
Estimation CommentsGMRs and corresponding 2-sided 95% CIs were calculated by exponentiating difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of age and vaccine group.
3. Primary Outcome:
Title Geometric Mean Ratios (GMRs) of SARS-CoV-2 Neutralizing Titers Between 20-microgram Dose and 30-microgram Dose at 1 Month After Dose 2: Primary Study
Description GMRs were calculated by exponentiating the mean difference of logarithmically transformed assay results between 2 vaccine groups. Assay results below the LLOQ were set to 0.5*LLOQ.
Time Frame 1 Month after Dose 2
Anticipated Reporting Date September 2022

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
Outcome Measure Data Not Reported
4. Primary Outcome:
Title Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Primary Study
Description Local reactions were collected by the participant using an electronic diary. Local reactions included redness, swelling, and pain at injection site after Dose 1. Redness, swelling, and pain at injection site after Dose 1 were reported.
Time Frame Within 7 days after Dose 1
Outcome Measure Data
Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure.
 
Arm/Group TitleBNT162b2 30 mcg: US Lot 1BNT162b2 30 mcg: US Lot 2BNT162b2 30 mcg: US Lot 3BNT162b2 30 mcg: EU LotBNT162b2 20 mcg: US Lot 1
Arm/Group DescriptionParticipants were randomized in primary study to receive 30 microgram (mcg) intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Overall Number of Participants Analyzed351 352 345 173 351
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Redness
1.1(0.3 to 2.9) 2.0(0.8 to 4.1) 2.9(1.4 to 5.3) 2.3(0.6 to 5.8) 2.0(0.8 to 4.1)
Swelling
2.0(0.8 to 4.1) 3.7(2.0 to 6.2) 3.8(2.0 to 6.4) 2.9(0.9 to 6.6) 3.4(1.8 to 5.9)
Pain at Injection Site
82.9(78.6 to 86.7) 79.3(74.6 to 83.4) 84.6(80.4 to 88.3) 86.1(80.1 to 90.9) 78.1(73.4 to 82.3)
5. Primary Outcome:
Title Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Primary Study
Description Local reactions were collected by the participant using an electronic diary. Local reactions included redness, swelling, and pain at injection site after Dose 2. Redness, swelling, and pain at injection site after Dose 2 were reported.
Time Frame Within 7 days after Dose 2
Outcome Measure Data
Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure.
 
Arm/Group TitleBNT162b2 30 mcg: US Lot 1BNT162b2 30 mcg: US Lot 2BNT162b2 30 mcg: US Lot 3BNT162b2 30 mcg: EU LotBNT162b2 20 mcg: US Lot 1
Arm/Group DescriptionParticipants were randomized in primary study to receive 30 microgram (mcg) intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Overall Number of Participants Analyzed349 350 343 172 348
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Redness
3.7(2.0 to 6.3) 4.0(2.2 to 6.6) 4.4(2.5 to 7.1) 2.9(1.0 to 6.7) 3.2(1.6 to 5.6)
Swelling
4.9(2.9 to 7.7) 6.0(3.8 to 9.0) 4.7(2.7 to 7.5) 3.5(1.3 to 7.4) 3.7(2.0 to 6.3)
Pain at Injection Site
80.2(75.7 to 84.3) 77.7(73.0 to 82.0) 83.1(78.7 to 86.9) 77.3(70.3 to 83.4) 79.6(75.0 to 83.7)
6. Primary Outcome:
Title Percentage of Participants With Local Reactions Within 7 Days After Any Dose: Primary Study
Description Local reactions were collected by the participant using an electronic diary. Local reactions included redness, swelling, and pain at injection site after each vaccination. Redness, swelling, and pain at injection site after any dose were reported.
Time Frame Within 7 days after any dose
Outcome Measure Data
Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of the study intervention. 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3).
 
Arm/Group TitleBNT162b2 30 mcg: US Lot 1BNT162b2 30 mcg: US Lot 2BNT162b2 30 mcg: US Lot 3BNT162b2 30 mcg: EU LotBNT162b2 20 mcg: US Lot 1
Arm/Group DescriptionParticipants were randomized in primary study to receive 30 microgram (mcg) intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Overall Number of Participants Analyzed351 352 347 173 351
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Redness
4.6(2.6 to 7.3) 5.4(3.3 to 8.3) 6.6(4.2 to 9.8) 4.6(2.0 to 8.9) 4.6(2.6 to 7.3)
Swelling
6.0(3.7 to 9.0) 8.8(6.1 to 12.3) 7.2(4.7 to 10.5) 4.6(2.0 to 8.9) 6.3(4.0 to 9.3)
Pain at Injection Site
90.9(87.4 to 93.7) 85.8(81.7 to 89.3) 91.1(87.6 to 93.8) 91.3(86.1 to 95.1) 89.5(85.8 to 92.5)
7. Primary Outcome:
Title Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Booster Study
Description Local reactions were collected by the participant using an electronic diary. Local reactions included redness, swelling, and pain at injection site after Dose 3. Redness, swelling, and pain at injection site after Dose 3 were reported.
Time Frame Within 7 days after Dose 3
Outcome Measure Data
Analysis Population Description
Safety population included all randomized participants who received dose 3 of the study intervention.
 
Arm/Group TitleBNT162b2 30 mcg: Booster DoseBNT162b2.B.1.351 30 mcg: Booster Dose
Arm/Group DescriptionParticipants who received 2 doses of 30 mcg BNT162b2 vaccine in primary study from US Lot 1 were randomized to booster study to receive a single 30 mcg intramuscular dose of BNT162b2 vaccine at 3 months after second dose in the primary study. Participants were followed up for safety for up to 28-35 days after vaccination.Participants who received 2 doses of 30 mcg BNT162b2 vaccine in primary study from US Lot 1, 2 or 3 were randomized to booster study to receive a single 30 mcg intramuscular dose of BNT162b2.B.1.351 vaccine at 3 months after second dose in the primary study. Participants were followed up for safety for up to 28-35 days after vaccination.
Overall Number of Participants Analyzed31 31
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Redness
9.7(2.0 to 25.8) 3.2(0.1 to 16.7)
Swelling
6.5(0.8 to 21.4) 6.5(0.8 to 21.4)
Pain at Injection site
90.3(74.2 to 98.0) 93.5(78.6 to 99.2)
8. Primary Outcome:
Title Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study
Description Systemic events were reported using an electronic diary. Fever was defined as temperature >=38.0 degree Celsius (C) and categorized as >=38.0 to 38.4 C; >38.4 to 38.9 C; >38.9 to 40.0 C; >40.0 C. Systemic events including fever, fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain, vomiting, diarrhea, and use of antipyretic/analgesic medication after Dose 1 were reported.
Time Frame Within 7 days after Dose 1
Outcome Measure Data
Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure.
 
Arm/Group TitleBNT162b2 30 mcg: US Lot 1BNT162b2 30 mcg: US Lot 2BNT162b2 30 mcg: US Lot 3BNT162b2 30 mcg: EU LotBNT162b2 20 mcg: US Lot 1
Arm/Group DescriptionParticipants were randomized in primary study to receive 30 microgram (mcg) intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Overall Number of Participants Analyzed351 352 345 173 351
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Fever >=38.0 C
0.3(0.0 to 1.6) 0(0.0 to 1.0) 2.0(0.8 to 4.1) 1.2(0.1 to 4.1) 0(0.0 to 1.0)
Fever >=38.0 C to 38.4 C
0.3(0.0 to 1.6) 0(0.0 to 1.0) 1.2(0.3 to 2.9) 0.6(0.0 to 3.2) 0(0.0 to 1.0)
Fever >38.4 C to 38.9 C
0(0.0 to 1.0) 0(0.0 to 1.0) 0.6(0.1 to 2.1) 0.6(0.0 to 3.2) 0(0.0 to 1.0)
Fever >38.9 C to 40.0 C
0(0.0 to 1.0) 0(0.0 to 1.0) 0.3(0.0 to 1.6) 0(0.0 to 2.1) 0(0.0 to 1.0)
Fever >40.0 C
0(0.0 to 1.0) 0(0.0 to 1.0) 1(0.0 to 1.1) 0(0.0 to 2.1) 0(0.0 to 1.0)
Fatigue
53.3(47.9 to 58.6) 45.5(40.2 to 50.8) 50.7(45.3 to 56.1) 49.1(41.5 to 56.8) 49.0(43.7 to 54.4)
Headache
36.2(31.1 to 41.5) 32.7(27.8 to 37.8) 33.3(28.4 to 38.6) 38.7(31.4 to 46.4) 35.6(30.6 to 40.9)
Chills
8.5(5.8 to 12.0) 7.7(5.1 to 11.0) 10.1(7.2 to 13.8) 8.1(4.5 to 13.2) 6.8(4.4 to 10.0)
Vomiting
0.6(0.1 to 2.0) 0.6(0.1 to 2.0) 1.2(0.3 to 2.9) 0.6(0.0 to 3.2) 0.9(0.2 to 2.5)
Diarrhea
9.7(6.8 to 13.3) 8.0(5.4 to 11.3) 7.8(5.2 to 11.2) 9.2(5.4 to 14.6) 10.0(7.0 to 13.6)
New/worsened muscle pain
14.5(11.0 to 18.7) 13.1(9.7 to 17.0) 16.5(12.8 to 20.9) 17.3(12.0 to 23.8) 16.2(12.5 to 20.5)
New/worsened joint pain
6.8(4.4 to 10.0) 6.5(4.2 to 9.6) 7.0(4.5 to 10.2) 7.5(4.1 to 12.5) 6.6(4.2 to 9.7)
Use of antipyretic/analgesic medication
16.8(13.0 to 21.1) 14.5(11.0 to 18.6) 18.8(14.9 to 23.4) 22.0(16.0 to 28.9) 18.2(14.3 to 22.7)
9. Primary Outcome:
Title Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study
Description Systemic events were reported using an electronic diary. Fever was defined as temperature >=38.0 C and categorized as >=38.0 to 38.4 C; >38.4 to 38.9 C; >38.9 to 40.0 C; >40.0 C. Systemic events including fever, fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain, vomiting, diarrhea, and use of antipyretic/analgesic medication after Dose 2 were reported.
Time Frame Within 7 days after Dose 2
Outcome Measure Data
Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure.
 
Arm/Group TitleBNT162b2 30 mcg: US Lot 1BNT162b2 30 mcg: US Lot 2BNT162b2 30 mcg: US Lot 3BNT162b2 30 mcg: EU LotBNT162b2 20 mcg: US Lot 1
Arm/Group DescriptionParticipants were randomized in primary study to receive 30 microgram (mcg) intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Overall Number of Participants Analyzed349 350 343 172 348
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Fever >=38.0 C
7.2(4.7 to 10.4) 6.3(4.0 to 9.4) 6.7(4.3 to 9.9) 8.7(5.0 to 14.0) 5.7(3.5 to 8.7)
Fever >=38.0 C to 38.4 C
4.6(2.6 to 7.3) 3.4(1.8 to 5.9) 3.2(1.6 to 5.7) 6.4(3.2 to 11.2) 4.3(2.4 to 7.0)
Fever >38.4 C to 38.9 C
2.0(0.8 to 4.1) 2.0(0.8 to 4.1) 2.3(1.0 to 4.5) 1.2(0.1 to 4.1) 1.4(0.5 to 3.3)
Fever >38.9 C to 40.0 C
0.6(0.1 to 2.1) 0.9(0.2 to 2.5) 0.9(0.2 to 2.5) 1.2(0.1 to 4.1) 0(0.0 to 1.1)
Fever >40.0 C
0(0.0 to 1.1) 0(0.0 to 1.0) 0.3(0.0 to 1.6) 0(0.0 to 2.1) 0(0.0 to 2.1)
Fatigue
69.9(64.8 to 74.7) 66.6(61.4 to 71.5) 71.4(66.3 to 76.2) 69.8(62.3 to 76.5) 66.7(61.4 to 71.6)
Headache
57.0(51.6 to 62.3) 56.6(51.2 to 61.8) 56.9(51.4 to 62.2) 56.4(48.6 to 63.9) 50.6(45.2 to 55.9)
Chills
28.1(23.4 to 33.1) 31.1(26.3 to 36.3) 33.8(28.8 to 39.1) 28.5(21.9 to 35.9) 23.6(19.2 to 28.4)
Vomiting
2.3(1.0 to 4.5) 1.4(0.5 to 3.3) 2.3(1.0 to 4.5) 1.7(0.4 to 5.0) 1.4(0.5 to 3.3)
Diarrhea
8.3(5.6 to 11.7) 9.1(6.3 to 12.7) 7.9(5.3 to 11.2) 9.3(5.4 to 14.7) 6.9(4.5 to 10.1)
New/worsened muscle pain
32.7(27.8 to 37.9) 38.6(33.4 to 43.9) 35.6(30.5 to 40.9) 36.0(28.9 to 43.7) 35.6(30.6 to 40.9)
New/worsened joint pain
19.2(15.2 to 23.7) 24.6(20.2 to 29.4) 19.2(15.2 to 23.8) 19.2(13.6 to 25.9) 19.5(15.5 to 24.1)
Use of antipyretic/analgesic medication
35.2(30.2 to 40.5) 41.1(35.9 to 46.5) 40.8(35.6 to 46.2) 41.9(34.4 to 49.6) 37.9(32.8 to 43.3)
10. Primary Outcome:
Title Percentage of Participants With Systemic Events Within 7 Days After Any Dose: Primary Study
Description Systemic events were reported using an electronic diary. Fever was defined as temperature >=38.0 C and categorized as >=38.0 to 38.4 C; >38.4 to 38.9 C; >38.9 to 40.0 C; >40.0 C. Systemic events including fever, fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain, vomiting, diarrhea, and use of antipyretic/analgesic medication after any dose were reported.
Time Frame Within 7 days after any dose
Outcome Measure Data
Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of the study intervention. 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3).
 
Arm/Group TitleBNT162b2 30 mcg: US Lot 1BNT162b2 30 mcg: US Lot 2BNT162b2 30 mcg: US Lot 3BNT162b2 30 mcg: EU LotBNT162b2 20 mcg: US Lot 1
Arm/Group DescriptionParticipants were randomized in primary study to receive 30 microgram (mcg) intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Overall Number of Participants Analyzed351 352 347 173 351
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Fever >=38.0 C
7.4(4.9 to 10.7) 6.3(4.0 to 9.3) 8.4(5.7 to 11.8) 9.2(5.4 to 14.6) 5.7(3.5 to 8.7)
Fever >=38.0 C to 38.4 C
4.8(2.8 to 7.6) 3.4(1.8 to 5.9) 4.0(2.2 to 6.7) 6.4(3.2 to 11.1) 4.3(2.4 to 7.0)
Fever >38.4 C to 38.9 C
2.0(0.8 to 4.1) 2.0(0.8 to 4.1) 2.9(1.4 to 5.2) 1.7(0.4 to 5.0) 1.4(0.5 to 3.3)
Fever >38.9 C to 40.0 C
0.6(0.1 to 2.0) 0.9(0.2 to 2.5) 1.2(0.3 to 2.9) 1.2(0.1 to 4.1) 0(0.0 to 1.0)
Fever >40.0 C
0(0.0 to 1.0) 0(0.0 to 1.0) 0.3(0.0 to 1.6) 0(0.0 to 2.1) 0(0.0 to 1.0)
Fatigue
78.6(74.0 to 82.8) 73.6(68.6 to 78.1) 81.0(76.4 to 85.0) 76.9(69.9 to 82.9) 75.5(70.7 to 79.9)
Headache
66.7(61.5 to 71.6) 65.1(59.8 to 70.0) 64.3(59.0 to 69.3) 68.8(61.3 to 75.6) 63.8(58.5 to 68.9)
Chills
32.8(27.9 to 37.9) 34.1(29.1 to 39.3) 37.2(32.1 to 42.5) 32.4(25.5 to 39.9) 26.2(21.7 to 31.1)
Vomiting
2.8(1.4 to 5.2) 2.0(0.8 to 4.1) 3.5(1.8 to 6.0) 2.3(0.6 to 5.8) 2.3(1.0 to 4.4)
Diarrhea
16.2(12.5 to 20.5) 14.2(10.7 to 18.3) 13.8(10.4 to 17.9) 15.0(10.1 to 21.2) 15.4(11.8 to 19.6)
New/worsened muscle pain
38.7(33.6 to 44.1) 43.5(38.2 to 48.8) 43.2(37.9 to 48.6) 43.9(36.4 to 51.7) 40.5(35.3 to 45.8)
New/worsened joint pain
23.4(19.0 to 28.1) 27.3(22.7 to 32.2) 23.9(19.5 to 28.8) 24.3(18.1 to 31.4) 22.2(18.0 to 26.9)
Use of antipyretic/analgesic medication
41.9(36.7 to 47.2) 43.8(38.5 to 49.1) 46.4(41.1 to 51.8) 51.4(43.7 to 59.1) 43.6(38.3 to 49.0)
11. Primary Outcome:
Title Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Booster Study
Description Systemic events were reported using an electronic diary. Fever was defined as temperature >=38.0 C and categorized as >=38.0 to 38.4 C; >38.4 to 38.9 C; >38.9 to 40.0 C; >40.0 C. Systemic events including fever, fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain, vomiting, diarrhea, and use of antipyretic/analgesic medication after Dose 3 were reported.
Time Frame Within 7 days after Dose 3
Outcome Measure Data
Analysis Population Description
Safety population included all randomized participants who received dose 3 of the study intervention.
 
Arm/Group TitleBNT162b2 30 mcg: Booster DoseBNT162b2.B.1.351 30 mcg: Booster Dose
Arm/Group DescriptionParticipants who received 2 doses of 30 mcg BNT162b2 vaccine in primary study from US Lot 1 were randomized to booster study to receive a single 30 mcg intramuscular dose of BNT162b2 vaccine at 3 months after second dose in the primary study. Participants were followed up for safety for up to 28-35 days after vaccination.Participants who received 2 doses of 30 mcg BNT162b2 vaccine in primary study from US Lot 1, 2 or 3 were randomized to booster study to receive a single 30 mcg intramuscular dose of BNT162b2.B.1.351 vaccine at 3 months after second dose in the primary study. Participants were followed up for safety for up to 28-35 days after vaccination.
Overall Number of Participants Analyzed31 31
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Fever >=38.0 C
3.2(0.1 to 16.7) 6.5(0.8 to 21.4)
Fever >=38.0 C to 38.4 C
0(0.0 to 11.2) 6.5(0.8 to 21.4)
Fever >38.4 C to 38.9 C
3.2(0.1 to 16.7) 0(0.0 to 11.2)
Fever >38.9 C to 40.0 C
0(0.0 to 11.2) 0(0.0 to 11.2)
Fever >40.0 C
0(0.0 to 11.2) 0(0.0 to 11.2)
Fatigue
67.7(48.6 to 83.3) 83.9(66.3 to 94.5)
Headache
41.9(24.5 to 60.9) 58.1(39.1 to 75.5)
Chills
25.8(11.9 to 44.6) 19.4(7.5 to 37.5)
Vomiting
3.2(0.1 to 16.7) 0(0.0 to 11.2)
Diarrhea
16.1(5.5 to 33.7) 6.5(0.8 to 21.4)
New/worsened muscle pain
41.9(24.5 to 60.9) 19.4(7.5 to 37.5)
New/worsened joint pain
12.9(3.6 to 29.8) 12.9(3.6 to 29.8)
Use of antipyretic/analgesic medication
32.3(16.7 to 51.4) 35.5(19.2 to 54.6)
12. Primary Outcome:
Title Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 2: Primary Study
Description An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event.
Time Frame Day 1 of Dose 1 up to 1 Month after Dose 2 (for a maximum of 2 months)
Outcome Measure Data
Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of the study intervention.
 
Arm/Group TitleBNT162b2 30 mcg: US Lot 1BNT162b2 30 mcg: US Lot 2BNT162b2 30 mcg: US Lot 3BNT162b2 30 mcg: EU LotBNT162b2 20 mcg: US Lot 1
Arm/Group DescriptionParticipants were randomized in primary study to receive 30 microgram (mcg) intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Overall Number of Participants Analyzed351 352 346 173 351
Measure Type: Number
Unit of Measure: Percentage of participants
AEs
5.4 6.0 5.2 10.4 6.8
SAEs
0
0
 0.3 0.6
0
13. Primary Outcome:
Title Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Dose 3 to 1 Month After Dose 3: Booster Study
Description An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event.
Time Frame From Dose 3 to 1 Month after Dose 3 (for a maximum of 35 days)
Outcome Measure Data
Analysis Population Description
Safety population included all randomized participants who received Dose 3 of the study intervention.
 
Arm/Group TitleBNT162b2 30 mcg: Booster DoseBNT162b2.B.1.351 30 mcg: Booster Dose
Arm/Group DescriptionParticipants who received 2 doses of 30 mcg BNT162b2 vaccine in primary study from US Lot 1 were randomized to booster study to receive a single 30 mcg intramuscular dose of BNT162b2 vaccine at 3 months after second dose in the primary study. Participants were followed up for safety for up to 28-35 days after vaccination.Participants who received 2 doses of 30 mcg BNT162b2 vaccine in primary study from US Lot 1, 2 or 3 were randomized to booster study to receive a single 30 mcg intramuscular dose of BNT162b2.B.1.351 vaccine at 3 months after second dose in the primary study. Participants were followed up for safety for up to 28-35 days after vaccination.
Overall Number of Participants Analyzed31 31
Measure Type: Number
Unit of Measure: Percentage of participants
AEs
6.5 3.2
SAEs
0
0
14. Primary Outcome:
Title Geometric Mean Titers (GMTs) of SARS-CoV-2 Reference-strain at Baseline: Booster Study
Description
Time Frame Baseline (prior to Dose 1 of Primary study)
Anticipated Reporting Date September 2022

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
Outcome Measure Data Not Reported
15. Primary Outcome:
Title Geometric Mean Titers (GMTs) of SARS-CoV-2 Reference-strain 1 Month After Dose 2: Booster Study
Description
Time Frame 1 Month after Dose 2 of primary study
Anticipated Reporting Date September 2022

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
Outcome Measure Data Not Reported
16. Primary Outcome:
Title Geometric Mean Titers (GMTs) of SARS-CoV-2 Reference-strain Before Dose 3: Booster Study
Description
Time Frame Before Dose 3
Anticipated Reporting Date September 2022

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
Outcome Measure Data Not Reported
17. Primary Outcome:
Title Geometric Mean Titers (GMTs) of SARS-CoV-2 Reference-strain 1 Week After Dose 3: Booster Study
Description
Time Frame 1 Week after Dose 3
Anticipated Reporting Date September 2022

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
Outcome Measure Data Not Reported
18. Primary Outcome:
Title Geometric Mean Titers (GMTs) of SARS-CoV-2 Reference-strain 1 Month After Dose 3: Booster Study
Description
Time Frame 1 Month after Dose 3
Anticipated Reporting Date September 2022

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
Outcome Measure Data Not Reported
19. Primary Outcome:
Title Geometric Mean Titers (GMTs) of SARS-CoV-2 B.1.351-strain at Baseline: Booster Study
Description
Time Frame Baseline (prior to Dose 1 of Primary study)
Anticipated Reporting Date September 2022

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
Outcome Measure Data Not Reported
20. Primary Outcome:
Title Geometric Mean Titers (GMTs) of SARS-CoV-2 B.1.351-strain 1 Month After Dose 2: Booster Study
Description
Time Frame 1 Month after Dose 2 of primary study
Anticipated Reporting Date September 2022

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
Outcome Measure Data Not Reported
21. Primary Outcome:
Title Geometric Mean Titers (GMTs) of SARS-CoV-2 B.1.351-strain Before Dose 3: Booster Study
Description
Time Frame Before Dose 3
Anticipated Reporting Date September 2022

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
Outcome Measure Data Not Reported
22. Primary Outcome:
Title Geometric Mean Titers (GMTs) of SARS-CoV-2 B.1.351-strain 1 Week After Dose 3: Booster Study
Description
Time Frame 1 Week after Dose 3
Anticipated Reporting Date September 2022

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
Outcome Measure Data Not Reported
23. Primary Outcome:
Title Geometric Mean Titers (GMTs) of SARS-CoV-2 B.1.351-strain 1 Month After Dose 3: Booster Study
Description
Time Frame 1 Month after Dose 3
Anticipated Reporting Date September 2022

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
Outcome Measure Data Not Reported
24. Primary Outcome:
Title Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels at Baseline: Booster Study
Description GMCs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
Time Frame Baseline (prior to Dose 1 of Primary study)
Anticipated Reporting Date September 2022

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
Outcome Measure Data Not Reported
25. Primary Outcome:
Title Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels 1 Month After Dose 2: Booster Study
Description GMCs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
Time Frame 1 Month after Dose 2 of primary study
Anticipated Reporting Date September 2022

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
Outcome Measure Data Not Reported
26. Primary Outcome:
Title Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels Before Dose 3: Booster Study
Description GMCs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
Time Frame Before Dose 3
Anticipated Reporting Date September 2022

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
Outcome Measure Data Not Reported
27. Primary Outcome:
Title Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels 1 Week After Dose 3: Booster Study
Description GMCs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
Time Frame 1 Week after Dose 3
Anticipated Reporting Date September 2022

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
Outcome Measure Data Not Reported
28. Primary Outcome:
Title Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels 1 Month After Dose 3: Booster Study
Description GMCs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
Time Frame 1 Month after Dose 3
Anticipated Reporting Date September 2022

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
Outcome Measure Data Not Reported
29. Primary Outcome:
Title Geometric Mean Fold Rises (GMFRs) in Full-length S-binding IgG Levels From 1 Month After Dose 2 to 1 Week After Dose 3: Booster Study
Description GMFRs were defined as ratios of the geometric mean concentration of IgG at 1 week after Dose 3 to the geometric mean concentration of IgG at 1 month after dose 2. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
Time Frame From 1 Month after Dose 2 to 1 Week after Dose 3
Anticipated Reporting Date September 2022

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
Outcome Measure Data Not Reported
30. Primary Outcome:
Title Geometric Mean Fold Rises (GMFRs) in Full-length S-binding IgG Levels From 1 Month After Dose 2 to 1 Month After Dose 3: Booster Study
Description GMFRs were defined as ratios of the geometric mean concentration of IgG at 1 month after Dose 3 to the geometric mean concentration of IgG at 1 month after dose 2. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
Time Frame From 1 Month after Dose 2 to 1 Month after Dose 3
Anticipated Reporting Date September 2022

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
Outcome Measure Data Not Reported
31. Primary Outcome:
Title Geometric Mean Fold Rises (GMFRs) in Full-length S-binding IgG Levels Before Dose 3 to 1 Week After Dose 3: Booster Study
Description GMFRs were defined as ratios of the geometric mean concentration of IgG at 1 week after Dose 3 to the geometric mean concentration of IgG before dose 3. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
Time Frame Before Dose 3 to 1 Week after Dose 3
Anticipated Reporting Date September 2022

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
Outcome Measure Data Not Reported
32. Primary Outcome:
Title Geometric Mean Fold Rises (GMFRs) in Full-length S-binding IgG Levels Before Dose 3 to 1 Month After Dose 3: Booster Study
Description GMFRs were defined as ratios of the geometric mean concentration of IgG at 1 month after Dose 3 to the geometric mean concentration of IgG before dose 3. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
Time Frame Before Dose 3 to 1 Month after Dose 3
Anticipated Reporting Date September 2022

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
Outcome Measure Data Not Reported
33. Primary Outcome:
Title Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 Reference-strain From 1 Month After Dose 2 to 1 Week After Dose 3: Booster Study
Description GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 reference-strain at 1 week after Dose 3 to the geometric mean titers of SARS-CoV-2 reference-strain at 1 month after dose 2. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
Time Frame From 1 Month after Dose 2 to 1 Week after Dose 3
Anticipated Reporting Date September 2022

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
Outcome Measure Data Not Reported
34. Primary Outcome:
Title Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 Reference-strain From 1 Month After Dose 2 to 1 Month After Dose 3: Booster Study
Description GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 reference-strain at 1 month after Dose 3 to the geometric mean titers of SARS-CoV-2 reference-strain at 1 month after dose 2. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
Time Frame From 1 Month after Dose 2 to 1 Month after Dose 3
Anticipated Reporting Date September 2022

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
Outcome Measure Data Not Reported
35. Primary Outcome:
Title Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 Reference-strain Before Dose 3 to 1 Week After Dose 3: Booster Study
Description GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 reference-strain at 1 week after Dose 3 to the geometric mean titers of SARS-CoV-2 reference-strain before dose 3. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
Time Frame Before Dose 3 to 1 Week after Dose 3
Anticipated Reporting Date September 2022

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
Outcome Measure Data Not Reported
36. Primary Outcome:
Title Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 Reference-strain Before Dose 3 to 1 Month After Dose 3: Booster Study
Description GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 reference-strain at 1 month after Dose 3 to the geometric mean titers of SARS-CoV-2 reference-strain before dose 3. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
Time Frame Before Dose 3 to 1 Month after Dose 3
Anticipated Reporting Date September 2022

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
Outcome Measure Data Not Reported
37. Primary Outcome:
Title Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 B.1.351-strain From 1 Month After Dose 2 to 1 Week After Dose 3: Booster Study
Description GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 B.1.351-strain at 1 week after Dose 3 to the geometric mean titers of SARS-CoV-2 B.1.351-strain at 1 month after dose 2. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
Time Frame From 1 Month after Dose 2 to 1 Week after Dose 3
Anticipated Reporting Date September 2022

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
Outcome Measure Data Not Reported
38. Primary Outcome:
Title Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 B.1.351-strain From 1 Month After Dose 2 to 1 Month After Dose 3: Booster Study
Description GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 B.1.351-strain at 1 month after Dose 3 to the geometric mean titers of SARS-CoV-2 B.1.351-strain at 1 month after dose 2. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
Time Frame From 1 Month after Dose 2 to 1 Month after Dose 3
Anticipated Reporting Date September 2022

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
Outcome Measure Data Not Reported
39. Primary Outcome:
Title Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 B.1.351-strain Before Dose 3 to 1 Week After Dose 3: Booster Study
Description GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 B.1.351-strain at 1 week after Dose 3 to the geometric mean titers of SARS-CoV-2 B.1.351-strain before dose 3. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
Time Frame Before Dose 3 to 1 Week after Dose 3
Anticipated Reporting Date September 2022

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
Outcome Measure Data Not Reported
40. Primary Outcome:
Title Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 B.1.351-strain Before Dose 3 to 1 Month After Dose 3: Booster Study
Description GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 B.1.351-strain at 1 month after Dose 3 to the geometric mean titers of SARS-CoV-2 B.1.351-strain before dose 3. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
Time Frame Before Dose 3 to 1 Month after Dose 3
Anticipated Reporting Date September 2022

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
Outcome Measure Data Not Reported
41. Primary Outcome:
Title Percentage of Participants With Seroresponse to Reference Strain at 1 Month After Dose 2: Booster Study
Description Seroresponse was defined as greater than equal to (>=) 4-fold increase from baseline (before Dose 1 in primary study) to the specified time point. If the baseline measurement was below LLOQ, a post vaccination measurement of >=4*LLOQ was considered a seroresponse.
Time Frame 1 Month after Dose 2
Anticipated Reporting Date September 2022

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
Outcome Measure Data Not Reported
42. Primary Outcome:
Title Percentage of Participants With Seroresponse to Reference Strain Before Dose 3: Booster Study
Description Seroresponse was defined as >=4-fold increase from baseline (before Dose 1 in primary study) to the specified time point. If the baseline measurement was below LLOQ, a post vaccination measurement of >=4*LLOQ was considered a seroresponse.
Time Frame Before Dose 3
Anticipated Reporting Date September 2022

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
Outcome Measure Data Not Reported
43. Primary Outcome:
Title Percentage of Participants With Seroresponse to Reference Strain 1 Week After Dose 3: Booster Study
Description Seroresponse was defined as >=4-fold increase from baseline (before Dose 1 in primary study) to the specified time point. If the baseline measurement was below LLOQ, a post vaccination measurement of >=4*LLOQ was considered a seroresponse.
Time Frame 1 Week after Dose 3
Anticipated Reporting Date September 2022

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
Outcome Measure Data Not Reported
44. Primary Outcome:
Title Percentage of Participants With Seroresponse to Reference Strain 1 Month After Dose 3: Booster Study
Description Seroresponse was defined as >=4-fold increase from baseline (before Dose 1 in primary study) to the specified time point. If the baseline measurement was below LLOQ, a post vaccination measurement of >=4*LLOQ was considered a seroresponse.
Time Frame 1 Month after Dose 3
Anticipated Reporting Date September 2022

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
Outcome Measure Data Not Reported
45. Primary Outcome:
Title Percentage of Participants With Seroresponse to B.1.351 Variant Strain at 1 Month After Dose 2: Booster Study
Description Seroresponse was defined as >=4-fold increase from baseline (before Dose 1 in primary study) to the specified time point. If the baseline measurement was below LLOQ, a post vaccination measurement of >=4*LLOQ was considered a seroresponse.
Time Frame 1 Month after Dose 2
Anticipated Reporting Date September 2022

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
Outcome Measure Data Not Reported
46. Primary Outcome:
Title Percentage of Participants With Seroresponse to B.1.351 Variant Strain Before Dose 3: Booster Study
Description Seroresponse was defined as >=4-fold increase from baseline (before Dose 1 in primary study) to the specified time point. If the baseline measurement was below LLOQ, a post vaccination measurement of >=4*LLOQ was considered a seroresponse.
Time Frame Before Dose 3
Anticipated Reporting Date September 2022

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
Outcome Measure Data Not Reported
47. Primary Outcome:
Title Percentage of Participants With Seroresponse to B.1.351 Variant Strain 1 Week After Dose 3: Booster Study
Description Seroresponse was defined as >=4-fold increase from baseline (before Dose 1 in primary study) to the specified time point. If the baseline measurement was below LLOQ, a post vaccination measurement of >=4*LLOQ was considered a seroresponse.
Time Frame 1 Week after Dose 3
Anticipated Reporting Date September 2022

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
Outcome Measure Data Not Reported
48. Primary Outcome:
Title Percentage of Participants With Seroresponse to B.1.351 Variant Strain 1 Month After Dose 3: Booster Study
Description Seroresponse was defined as >=4-fold increase from baseline (before Dose 1 in primary study) to the specified time point. If the baseline measurement was below LLOQ, a post vaccination measurement of >=4*LLOQ was considered a seroresponse.
Time Frame 1 Month after Dose 3
Anticipated Reporting Date September 2022

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
Outcome Measure Data Not Reported
49. Secondary Outcome:
Title Geometric Mean Concentrations (GMCs) of Full-Length S-Binding IgG Levels at Baseline and 1 Month After Dose 2 for 30 mcg Dose of BNT162b2: Primary Study
Description GMCs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5* LLOQ.
Time Frame Baseline (before Dose 1), 1 Month after Dose 2
Outcome Measure Data
Analysis Population Description
Evaluable immunogenicity population: Participants who received 2 doses of vaccine in primary study, with Dose 2 received within predefined window, had at least 1 valid immunogenicity result from blood sample collected within an appropriate window at 1 month after Dose 2, were negative for both SARS-CoV-2 test (RT-PCR and N-blinding antibody) during study and had no other protocol deviations determined by clinician. Here, "N"= participants evaluable for this outcome measure.
   
Arm/Group TitleBNT162b2 30 mcg: US Lot 1BNT162b2 30 mcg: US Lot 2BNT162b2 30 mcg: US Lot 3BNT162b2 30 mcg: EU Lot
Arm/Group DescriptionParticipants were randomized in primary study to receive 30 microgram (mcg) intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Overall Number of Participants Analyzed324 311 310 160
Geometric Mean (95% Confidence Interval)
Unit of Measure: Unit per milliliter
 
Baseline
Number Analyzed Participants Participants Participants Participants
3.1(2.7 to 3.5) 2.6(2.3 to 3.0) 2.6(2.2 to 3.0) 2.6(2.1 to 3.2)
1 Month After Dose 2
Number Analyzed Participants Participants Participants Participants
6269.8(5717.7 to 6875.2) 6222.3(5721.5 to 6766.9) 6818.9(6280.9 to 7403.1) 6098.9(5446.0 to 6830.1)
50. Secondary Outcome:
Title Geometric Mean Fold Rises (GMFRs) in Full-Length S-Binding lgG Levels From Baseline to 1 Month After Dose 2 for 30 mcg Dose of BNT162b2: Primary Study
Description GMFRs were defined as ratios of the geometric mean concentration of IgG at 1 month after Dose 2 to the geometric mean concentration of IgG at Baseline. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
Time Frame From Baseline (before Dose 1) up to 1 Month after Dose 2
Outcome Measure Data
Analysis Population Description
Evaluable immunogenicity population: Participants who received 2 doses of vaccine in primary study, with Dose 2 received within predefined window, had at least 1 valid immunogenicity result from blood sample collected within an appropriate window at 1 month after Dose 2, were negative for both SARS-CoV-2 test (RT-PCR and N-blinding antibody) during study and had no other protocol deviations determined by clinician. Here, "N"= participants evaluable for this outcome measure.
 
Arm/Group TitleBNT162b2 30 mcg: US Lot 1BNT162b2 30 mcg: US Lot 2BNT162b2 30 mcg: US Lot 3BNT162b2 30 mcg: EU Lot
Arm/Group DescriptionParticipants were randomized in primary study to receive 30 microgram (mcg) intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months.
Overall Number of Participants Analyzed323 311 310 160
Geometric Mean (95% Confidence Interval)
Unit of Measure: Fold rise
2036.6(1744.5 to 2377.7) 2367.1(2028.6 to 2762.2) 2645.2(2271.2 to 3080.8) 2373.8(1901.2 to 2963.9)
51. Secondary Outcome:
Title Geometric Mean Concentrations (GMCs) of SARS-CoV-2 Neutralizing Titers at Baseline and 1 Month After Dose 2 for 20 mcg and 30 mcg Dose of BNT162b2 From US Lot 1: Primary Study
Description GMCs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
Time Frame Baseline (before Dose 1), 1 Month after Dose 2
Anticipated Reporting Date September 2022

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
Outcome Measure Data Not Reported
52. Secondary Outcome:
Title Geometric Mean Fold Rises (GMFRs) in SARS-CoV-2 Neutralizing Titers From Baseline to 1 Month After Dose 2 for 20 mcg and 30 mcg Dose of BNT162b2 From US Lot 1: Primary Study
Description GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 at 1 month after Dose 2 to the geometric mean titers of SARS-CoV-2 at Baseline. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5* LLOQ.
Time Frame From Baseline (before Dose 1) up to 1 Month after Dose 2
Anticipated Reporting Date September 2022

Quality Control Review Comment provided by the National Library of Medicine:

  1. Required information appears to be missing.
Outcome Measure Data Not Reported
Open or close this module Adverse Events
 
Time Frame AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose
Adverse Event Reporting Description Safety population: participants who received at least 1 dose and had safety data available. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment). 1 participant randomized to US Lot 1 was administered US Lot 1 for Dose 1 and US Lot 3 for Dose 2, therefore, the participant was included in both reporting groups (US Lot 1 and US Lot 3) for non-SAEs.
 
Arm/Group Title BNT162b2 30 mcg: US Lot 1 BNT162b2 30 mcg: US Lot 2 BNT162b2 30 mcg: US Lot 3 BNT162b2 30 mcg: EU Lot BNT162b2 20 mcg: US Lot 1 BNT162b2 30 mcg: Booster Dose BNT162b2.B.1.351 30 mcg: Booster Dose
Arm/Group Description Participants were randomized in primary study to receive 30 microgram (mcg) intramuscular dose of BNT162b2 (US Lot 1) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months. Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 2) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months. Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (US Lot 3) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months. Participants were randomized in primary study to receive 30 mcg intramuscular dose of BNT162b2 (EU Lot) vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months. Participants were randomized in primary study to receive 20 mcg intramuscular dose of BNT162b2 vaccine as 2-dose schedule separated by 21 days. Participants were followed up for safety for up to 28-35 days after second dose of vaccine, for a maximum of 2 months. Participants who received 2 doses of 30 mcg BNT162b2 vaccine in primary study from US Lot 1 were randomized to booster study to receive a single 30 mcg intramuscular dose of BNT162b2 vaccine at 3 months after second dose in the primary study. Participants were followed up for safety for up to 28-35 days after vaccination. Participants who received 2 doses of 30 mcg BNT162b2 vaccine in primary study from US Lot 1, 2 or 3 were randomized to booster study to receive a single 30 mcg intramuscular dose of BNT162b2.B.1.351 vaccine at 3 months after second dose in the primary study. Participants were followed up for safety for up to 28-35 days after vaccination.
All-Cause Mortality
  BNT162b2 30 mcg: US Lot 1BNT162b2 30 mcg: US Lot 2BNT162b2 30 mcg: US Lot 3BNT162b2 30 mcg: EU LotBNT162b2 20 mcg: US Lot 1BNT162b2 30 mcg: Booster DoseBNT162b2.B.1.351 30 mcg: Booster Dose
 Affected / At Risk (%)Affected / At Risk (%)Affected / At Risk (%)Affected / At Risk (%)Affected / At Risk (%)Affected / At Risk (%)Affected / At Risk (%)
Total 0 / 351 (0%)0 / 352 (0%)0 / 346 (0%)0 / 173 (0%)0 / 351 (0%)0 / 31 (0%)0 / 31 (0%)
Serious Adverse Events
  BNT162b2 30 mcg: US Lot 1BNT162b2 30 mcg: US Lot 2BNT162b2 30 mcg: US Lot 3BNT162b2 30 mcg: EU LotBNT162b2 20 mcg: US Lot 1BNT162b2 30 mcg: Booster DoseBNT162b2.B.1.351 30 mcg: Booster Dose
 Affected / At Risk (%)Affected / At Risk (%)Affected / At Risk (%)Affected / At Risk (%)Affected / At Risk (%)Affected / At Risk (%)Affected / At Risk (%)
Total 0 / 351 (0%)0 / 352 (0%)1 / 346 (0.29%)1 / 173 (0.58%)0 / 351 (0%)0 / 31 (0%)0 / 31 (0%)
Nervous system disorders
Migrainosus ∗ A 0 / 351 (0%)0 / 352 (0%)0 / 346 (0%)1 / 173 (0.58%)0 / 351 (0%)0 / 31 (0%)0 / 31 (0%)
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous ∗ A 0 / 351 (0%)0 / 352 (0%)1 / 346 (0.29%)0 / 173 (0%)0 / 351 (0%)0 / 31 (0%)0 / 31 (0%)
∗Indicates events were collected by non-systematic methods.
ATerm from vocabulary, MedDRA 24.0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
  BNT162b2 30 mcg: US Lot 1BNT162b2 30 mcg: US Lot 2BNT162b2 30 mcg: US Lot 3BNT162b2 30 mcg: EU LotBNT162b2 20 mcg: US Lot 1BNT162b2 30 mcg: Booster DoseBNT162b2.B.1.351 30 mcg: Booster Dose
 Affected / At Risk (%)Affected / At Risk (%)Affected / At Risk (%)Affected / At Risk (%)Affected / At Risk (%)Affected / At Risk (%)Affected / At Risk (%)
Total 341 / 351 (97.15%)336 / 352 (95.45%)335 / 347 (96.54%)165 / 173 (95.38%)342 / 351 (97.44%)30 / 31 (96.77%)31 / 31 (100%)
Blood and lymphatic system disorders
Lymphadenopathy ∗ A 0 / 351 (0%)0 / 352 (0%)0 / 347 (0%)0 / 173 (0%)0 / 351 (0%)1 / 31 (3.23%)0 / 31 (0%)
Gastrointestinal disorders
Diarrhoea † A 57 / 351 (16.24%)50 / 352 (14.2%)48 / 347 (13.83%)26 / 173 (15.03%)54 / 351 (15.38%)5 / 31 (16.13%)2 / 31 (6.45%)
Vomiting † A 10 / 351 (2.85%)7 / 352 (1.99%)12 / 347 (3.46%)4 / 173 (2.31%)8 / 351 (2.28%)1 / 31 (3.23%)0 / 31 (0%)
General disorders
Chills † A 115 / 351 (32.76%)120 / 352 (34.09%)129 / 347 (37.18%)56 / 173 (32.37%)92 / 351 (26.21%)8 / 31 (25.81%)6 / 31 (19.35%)
Fatigue † A 276 / 351 (78.63%)259 / 352 (73.58%)281 / 347 (80.98%)133 / 173 (76.88%)265 / 351 (75.5%)21 / 31 (67.74%)26 / 31 (83.87%)
Injection site erythema † A 16 / 351 (4.56%)19 / 352 (5.4%)23 / 347 (6.63%)8 / 173 (4.62%)16 / 351 (4.56%)3 / 31 (9.68%)1 / 31 (3.23%)
Injection site pain † A 319 / 351 (90.88%)302 / 352 (85.8%)316 / 347 (91.07%)158 / 173 (91.33%)314 / 351 (89.46%)28 / 31 (90.32%)29 / 31 (93.55%)
Injection site swelling † A 21 / 351 (5.98%)31 / 352 (8.81%)25 / 347 (7.2%)8 / 173 (4.62%)22 / 351 (6.27%)2 / 31 (6.45%)2 / 31 (6.45%)
Pyrexia † A 26 / 351 (7.41%)22 / 352 (6.25%)29 / 347 (8.36%)16 / 173 (9.25%)20 / 351 (5.7%)1 / 31 (3.23%)2 / 31 (6.45%)
Musculoskeletal and connective tissue disorders
Arthralgia † A 82 / 351 (23.36%)96 / 352 (27.27%)83 / 347 (23.92%)42 / 173 (24.28%)78 / 351 (22.22%)4 / 31 (12.9%)4 / 31 (12.9%)
Myalgia † A 136 / 351 (38.75%)153 / 352 (43.47%)150 / 347 (43.23%)76 / 173 (43.93%)142 / 351 (40.46%)13 / 31 (41.94%)6 / 31 (19.35%)
Neck pain ∗ A 0 / 351 (0%)0 / 352 (0%)0 / 347 (0%)0 / 173 (0%)0 / 351 (0%)0 / 31 (0%)1 / 31 (3.23%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign abdominal neoplasm ∗ A 0 / 351 (0%)0 / 352 (0%)0 / 347 (0%)0 / 173 (0%)0 / 351 (0%)1 / 31 (3.23%)0 / 31 (0%)
Nervous system disorders
Headache † A 234 / 351 (66.67%)229 / 352 (65.06%)223 / 347 (64.27%)119 / 173 (68.79%)224 / 351 (63.82%)13 / 31 (41.94%)18 / 31 (58.06%)
Syncope ∗ A 0 / 351 (0%)0 / 352 (0%)0 / 347 (0%)2 / 173 (1.16%)0 / 351 (0%)0 / 31 (0%)0 / 31 (0%)
Skin and subcutaneous tissue disorders
Rash ∗ A 0 / 351 (0%)1 / 352 (0.28%)1 / 347 (0.29%)3 / 173 (1.73%)2 / 351 (0.57%)0 / 31 (0%)0 / 31 (0%)
†Indicates events were collected by systematic assessment.
∗Indicates events were collected by non-systematic methods.
ATerm from vocabulary, MedDRA 24.0
Open or close this module Limitations and Caveats
The evolving nature of the pandemic has required serology work to be focused on newly emerging strains as a matter of urgent priority, which has delayed serology work on earlier trials. Hence data is not yet available for all serology outcome measures.
Open or close this module More Information
Certain Agreements:
Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

PIs respectively trial sites shall not publish or refer to in writing or orally, in whole or in part, any data, information or materials generated from the study and the services, without the prior written consent of the sponsor.
Results Point of Contact:
Name/Official Title:
 BioNTech clinical trials patient information
Organization:
 BioNTech SE
Phone:
 +49 6131 9084 ext.0
Email:
 patients@biontech.de
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