A Study to Learn About New COVID-19 RNA Vaccine Candidates in COVID-19 Vaccine-Experienced Healthy Individuals

• ClinicalTrials.gov Identifier: NCT05472038
• Recruitment Status: Completed
• First Posted: July 25, 2022
• Last Update Posted: April 11, 2024
• Sponsor: BioNTech SE
• Collaborator: Pfizer
• Information provided by (Responsible Party): BioNTech SE

Study Description

Brief Summary:

The purpose of this clinical trial is to learn about the safety, tolerability and immunogenicity of BNT162b RNA-based SARS-CoV-2 vaccine candidates in adults to prevent COVID-19.

For all cohorts (groups of participants), this study is seeking participants who are healthy (who may have preexisting disease if it is stable); All participants will receive a single dose of the study vaccine at the first study clinic and will return to the study clinic at least 4 more times. At each clinic visit, a blood sample will be taken. The study is about 6 months long for each participant. The vaccine candidates in this study are investigational but are very similar to BNT162b2 (Comirnaty), a COVID-19 RNA vaccine approved for use in the US and in many countries.

For Cohort 1, this study included participants who were:

• 18 through 55 years of age
• have received 1 booster dose of a US-authorized COVID-19 vaccine, with the last dose being 90 or more days before Visit 1 of this study.

All participants in Cohort 1 will receive 1 of the 2 study vaccines at a 30 microgram dose: BNT162b5 Bivalent (WT/OMI BA.2) or BNT162b2 Bivalent (WT/OMI BA.1).

For Cohort 2, this study included participants who were:

• 12 years of age and older
• have received 3 prior doses of 30 micrograms BNT162b2, with the last dose being 150 to 365 days before Visit 1 of this study.

Participants 12 through 17 years of age will receive BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 micrograms.

Participants 18 years and older will receive BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at either a 30 microgram or a 60 microgram dose.

For Cohort 3, this study included participants who were:

• 18 years of age and older
• have received 3 prior doses of 30 micrograms BNT162b2, with the last dose being 150 to 365 days before Visit 1 of this study.
• Participants will receive BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 micrograms.

For Cohort 4, this study is seeking participants who are:

• 18 through 55 years of age
• have received 3 or 4 prior doses of a US-authorized mRNA COVID-19 vaccine (and dose level), with the last dose being a US-authorized BA.4/BA.5-adapted bivalent vaccine and dose level at least 150 days before Visit 1 of this study.

All participants in Cohort 4 will receive 1 of the 5 study vaccines at a 30 microgram dose: BNT162b2 Bivalent (Original/ OMI BA.4/BA.5), BNT162b5 Bivalent (Original/OMI BA.4/BA.5), BNT162b6 Bivalent (Original/OMI BA.4/BA.5), BNT162b7 Bivalent (Original/OMI BA.4/BA.5) or BNT162b7 Monovalent (OMI BA.4/BA.5).

Condition or disease	Intervention/treatment	Phase
SARS-CoV-2 Infection; COVID-19	Biological: BNT162b5 Bivalent (WT/OMI BA.2); Biological: BNT162b2 Bivalent (WT/OMI BA.1); Biological: BNT162b2 Bivalent (WT/OMI BA.4/BA.5); Biological: BNT162b5 Bivalent (Original/OMI BA.4/BA.5); Biological: BNT162b6 Bivalent (Original/OMI BA.4/BA.5); Biological: BNT162b7 Bivalent (Original/OMI BA.4/BA.5); Biological: BNT162b7 Monovalent (OMI BA.4/BA.5)	Phase 2; Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1454 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Phase 1/2/3, randomized, active-controlled, parallel group study.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Cohort 1 and Cohort 2 (18 years and older): Observer-blind Cohort 2 (12-17 years) and Cohort 3: Open-label Cohort 4: Observer-blind
• Primary Purpose: Prevention
• Official Title: AN INTERVENTIONAL, RANDOMIZED, ACTIVE-CONTROLLED, PHASE 1/2/3 STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF BNT162b RNA-BASED VACCINE CANDIDATES IN COVID-19 VACCINE-EXPERIENCED HEALTHY INDIVIDUALS
• Actual Study Start Date: July 26, 2022
• Actual Primary Completion Date: March 26, 2024
• Actual Study Completion Date: March 26, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Cohort 1: BNT162b5 Bivalent (WT/OMI BA.2); Participants will receive 30 µg of BNT162b5 Bivalent (WT/OMI BA.2) at Visit 1.	Biological: BNT162b5 Bivalent (WT/OMI BA.2); BNT162b5 Wild Type and BNT162b5 OMICRON [B.1.1.529 sublineage BA.2]
Experimental: Cohort 1: BNT162b2 Bivalent (WT/OMI BA.1); Participants will receive 30 µg of BNT162b2 Bivalent (WT/OMI BA.1) at Visit 1.	Biological: BNT162b2 Bivalent (WT/OMI BA.1); BNT162b2 Wild Type and BNT162b2 OMICRON [B.1.1.529 sublineage BA.1]
Experimental: Cohort 2 -Group 1: 12-17 years; 30 µg; Participants 12-17 years old will receive 30 µg of BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at Visit 1.	Biological: BNT162b2 Bivalent (WT/OMI BA.4/BA.5); BNT162b2 Wild Type and BNT162b2 OMICRON [B.1.1.529 sublineage BA.4/BA.5]
Experimental: Cohort 2 - Group 2: 18-55 years; 30 µg; Participants 18-55 years old will receive 30 µg of BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at Visit 1.	Biological: BNT162b2 Bivalent (WT/OMI BA.4/BA.5); BNT162b2 Wild Type and BNT162b2 OMICRON [B.1.1.529 sublineage BA.4/BA.5]
Experimental: Cohort 2 - Group 3: 18-55 years; 60 µg; Participants 18-55 years old will receive 60 µg of BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at Visit 1.	Biological: BNT162b2 Bivalent (WT/OMI BA.4/BA.5); BNT162b2 Wild Type and BNT162b2 OMICRON [B.1.1.529 sublineage BA.4/BA.5]
Experimental: Cohort 2 - Group 4: >55 years; 30 µg; Participants over 55 years old will receive 30 µg of BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at Visit 1.	Biological: BNT162b2 Bivalent (WT/OMI BA.4/BA.5); BNT162b2 Wild Type and BNT162b2 OMICRON [B.1.1.529 sublineage BA.4/BA.5]
Experimental: Cohort 2 - Group 5: >55 years; 60 µg; Participants over 55 years old will receive 60 µg of BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at Visit 1.	Biological: BNT162b2 Bivalent (WT/OMI BA.4/BA.5); BNT162b2 Wild Type and BNT162b2 OMICRON [B.1.1.529 sublineage BA.4/BA.5]
Experimental: Cohort 3 - Group 1: 18-55 years; 30 µg; Participants will receive BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 µg at Visit 1.	Biological: BNT162b2 Bivalent (WT/OMI BA.4/BA.5); BNT162b2 Wild Type and BNT162b2 OMICRON [B.1.1.529 sublineage BA.4/BA.5]
Experimental: Cohort 3 - Group 2: >55 years; 30 µg; Participants will receive BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 µg at Visit 1.	Biological: BNT162b2 Bivalent (WT/OMI BA.4/BA.5); BNT162b2 Wild Type and BNT162b2 OMICRON [B.1.1.529 sublineage BA.4/BA.5]
Active Comparator: Cohort 4: BNT162b2 Bivalent (Original/OMI BA.4/BA.5); Participants will receive 30 µg of BNT162b2 Bivalent (Original/OMI BA.4/BA.5) at Visit 1	Biological: BNT162b2 Bivalent (WT/OMI BA.4/BA.5); BNT162b2 Wild Type and BNT162b2 OMICRON [B.1.1.529 sublineage BA.4/BA.5]
Experimental: Cohort 4: BNT162b5 Bivalent (Original/OMI BA.4/BA.5); Participants will receive 30 µg of BNT162b5 Bivalent (Original/OMI BA.4/BA.5) at Visit 1	Biological: BNT162b5 Bivalent (Original/OMI BA.4/BA.5); BNT162b5 Wild Type and BNT162b5 OMICRON [B.1.1.529 sublineage BA.4/BA.5]
Experimental: Cohort 4: BNT162b6 Bivalent (Original/OMI BA.4/BA.5); Participants will receive 30 µg of BNT162b6 Bivalent (Original/OMI BA.4/BA.5) at Visit 1	Biological: BNT162b6 Bivalent (Original/OMI BA.4/BA.5); BNT162b6 Wild Type and BNT162b6 OMICRON [B.1.1.529 sublineage BA.4/BA.5]
Experimental: Cohort 4: BNT162b7 Bivalent (Original/OMI BA.4/BA.5); Participants will receive 30 µg of BNT162b7 Bivalent (Original/OMI BA.4/BA.5) at Visit 1	Biological: BNT162b7 Bivalent (Original/OMI BA.4/BA.5); BNT162b7 Wild Type and BNT162b7 OMICRON [B.1.1.529 sublineage BA.4/BA.5]
Experimental: Cohort 4: BNT162b7 Monovalent (OMI BA.4/BA.5); Participants will receive 30 µg of BNT162b7 Monovalent (OMI BA.4/BA.5) at Visit 1	Biological: BNT162b7 Monovalent (OMI BA.4/BA.5); BNT162b7 OMICRON [B.1.1.529 sublineage BA.4/BA.5]

Outcome Measures

Primary Outcome Measures :

1. All Cohorts: Percentage of participants reporting local reactions [ Time Frame: For 7 days following the study vaccination ]
   Pain at the injection site, redness, and swelling, as self-reported in electronic diaries
2. All Cohorts: Percentage of participants reporting systemic events [ Time Frame: For 7 days following the study vaccination ]
   Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain, as self-reported in electronic diaries
3. All Cohorts: Percentage of participants reporting adverse events [ Time Frame: For 1 month following the study vaccination ]
   As elicited by the investigational staff
4. All Cohorts: Percentage of participants reporting serious adverse events [ Time Frame: For 6 months following the study vaccination ]
   As elicited by the investigational staff
5. Cohort 1: Geometric Mean Titers (GMT) of SARS-CoV-2 Omicron (BA.2), Omicron (BA.1), and reference strain neutralizing antibody levels for BNT162b5 Bivalent (WT/OMI BA.2) 30 µg and BNT162b2 Bivalent (WT/OMI BA.1) 30 µg [ Time Frame: Before study vaccination (Day 1). ]
   As measured at the central laboratory.
6. Cohort 1: Geometric Mean Titers (GMT) of SARS-CoV-2 Omicron (BA.2), Omicron (BA.1), and reference strain neutralizing antibody levels for BNT162b5 Bivalent (WT/OMI BA.2) 30 µg and BNT162b2 Bivalent (WT/OMI BA.1) 30 µg [ Time Frame: At 1 month after study vaccination. ]
   As measured at the central laboratory.
7. Cohort 1: Geometric Mean Fold Rise (GMFR; change between 2 timepoints) of SARS-CoV-2 Omicron (BA.2), Omicron (BA.1), and reference strain neutralizing antibody levels for BNT162b5 Bivalent (WT/OMI BA.2) 30 µg and BNT162b2 Bivalent (WT/OMI BA.1) 30 µg. [ Time Frame: From before study vaccination (Day 1) to 1 month after study vaccination. ]
   As measured at the central laboratory.
8. Cohort 1: Percentages of participants with seroresponse to BNT162b5 Bivalent (WT/OMI BA.2) 30 µg and BNT162b2 Bivalent (WT/OMI BA.1) 30 µg in terms of GMTs of SARS-CoV-2 Omicron (BA.2), Omicron (BA.1), and reference strain neutralizing antibody levels. [ Time Frame: At 1 month after study vaccination. ]
   As measured at the central laboratory.
9. Cohort 2: Geometric Mean Titers (GMT) of SARS-CoV-2 Omicron (BA.4/BA.5), Omicron (BA.1), and reference strain neutralizing antibody levels for BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 µg or 60 µg and BNT162b2 Bivalent (WT/OMI BA.1) 30 µg or 60 µg [ Time Frame: Before study vaccination (Day 1). ]
   As measured at the central laboratory.
10. Cohort 2: Geometric Mean Titers (GMT) of SARS-CoV-2 Omicron (BA.4/BA.5), Omicron (BA.1), and reference strain neutralizing antibody levels for BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 µg or 60 µg and BNT162b2 Bivalent (WT/OMI BA.1) 30 µg or 60 µg [ Time Frame: At 1 month after study vaccination. ]
    As measured at the central laboratory.
11. Cohort 2: GMFR (change between 2 timepoints) of SARS-CoV-2 Omicron (BA.4/BA.5), Omicron (BA.1), and reference strain neutralizing antibody levels for BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 µg or 60 µg and BNT162b2 Bivalent (WT/OMI BA.1) 30 µg or 60 µg.. [ Time Frame: From before study vaccination (Day 1) to 1 month after study vaccination. ]
    As measured at the central laboratory.
12. Cohort 2: % of participants with seroresponse to BNT162b2 Bivalent(WT/OMI BA.4/BA.5) 30µg or 60µg and BNT162b2 Bivalent(WT/OMI BA.1) 30µg or 60µg for GMTs of SARS-CoV-2 Omicron(BA.4/BA.5), Omicron(BA.1), and reference strain neutralizing antibody levels. [ Time Frame: At 1 month after study vaccination ]
    As measured at the central laboratory.
13. Cohorts 2+3 (>55 yrs) Superiority analysis: Geometric Mean Ratio (GMR) of SARS-CoV-2 Omicron (BA.4/BA.5)-neutralizing antibody levels for BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 μg to BNT162b2 30 μg (C4591031 Substudy E). [ Time Frame: At 1 month after study vaccination. ]
    As measured at the central laboratory.
14. Cohorts 2+3 (>55 yrs) Noninferiority analysis: Differences in %s of participants with seroresponse to SARS-CoV-2 Omicron BA.4/BA.5 after vaccination with BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 μg or BNT162b2 30 μg (C4591031 Substudy E). [ Time Frame: At 1 month after study vaccination. ]
    As measured at the central laboratory.
15. Cohorts 2+3 (18-55 yrs), C2+3 (>55 yrs) Noninferiority analysis: GMR of SARS-CoV-2 Omicron (BA.4/BA.5)-neutralizing antibody levels for BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 μg in participants 18-55 yrs compared to participants >55 yrs. [ Time Frame: At 1 month after study vaccination. ]
    As measured at the central laboratory.
16. Cohorts 2+3 (18-55 yrs), C2+3 (>55 yrs) Noninferiority analysis: Differences in %s of pts with seroresponse to SARS-CoV-2 Omicron BA.4/BA.5 after vaccination with BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 μg in pts 18-55 yrs compared to pts >55 yrs. [ Time Frame: At 1 month after study vaccination. ]
    As measured at the central laboratory.
17. Cohort 4: Geometric Mean Titers (GMT) of SARS-CoV-2 Omicron (BA.4/BA.5) and reference strain neutralizing antibody levels for 30µg BNT162b2 Bivalent, BNT162b5 Bivalent, BNT162b6 Bivalent, BNT162b7 Bivalent and BNT162b7 Monovalent [ Time Frame: Before study vaccination (Day 1) ]
    As measured at the central laboratory
18. Cohort 4: Geometric Mean Titers (GMT) of SARS-CoV-2 Omicron (BA.4/BA.5) and reference strain neutralizing antibody levels for 30µg BNT162b2 Bivalent, BNT162b5 Bivalent, BNT162b6 Bivalent, BNT162b7 Bivalent and BNT162b7 Monovalent [ Time Frame: At 1 month after study vaccination ]
    As measured at the central laboratory
19. Cohort 4: GMFR (change between 2 timepoints) of SARS-CoV-2 Omicron (BA.4/BA.5) and reference strain neutralizing antibody levels for 30µg BNT162b2 Bivalent, BNT162b5 Bivalent, BNT162b6 Bivalent, BNT162b7 Bivalent and BNT162b7 Monovalent [ Time Frame: From before study vaccination (Day 1) to 1 month after study vaccination. ]
    As measured at the central laboratory
20. Cohort 4: % of participants with seroresponse to 30µg BNT162b2 Bivalent, BNT162b5 Bivalent, BNT162b6 Bivalent, BNT162b7 Bivalent and BNT162b7 Monovalent for GMTs of SARS-CoV-2 Omicron(BA.4/BA.5), and reference strain neutralizing antibody levels [ Time Frame: At 1 month after study vaccination ]
    As measured at the central laboratory

Secondary Outcome Measures :

1. Cohorts 2+3 (>55 yrs) Noninferiority analysis: GMR of SARS-CoV-2 reference strain neutralizing antibody levels for BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 μg to BNT162b2 30 μg (C4591031 Substudy E). [ Time Frame: At 1 month after study vaccination. ]
   As measured at the central laboratory.
2. Cohorts 2+3 (18-55 yrs), Cohorts 2+3 (>55 yrs): GMTs of SARS-CoV-2 Omicron (BA.4/BA.5) and reference strain neutralizing antibody levels for BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 μg and BNT162b2 30 μg (C4591031 Substudy E). [ Time Frame: Before study vaccination (Day 1). ]
   As measured at the central laboratory.
3. Cohorts 2+3 (18-55 yrs), Cohorts 2+3 (>55 yrs): GMTs of SARS-CoV-2 Omicron (BA.4/BA.5) and reference strain neutralizing antibody levels for BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 μg and BNT162b2 30 μg (C4591031 Substudy E). [ Time Frame: At 1 month after study vaccination. ]
   As measured at the central laboratory.
4. Cohorts 2+3 (18-55 yrs), C2+3 (>55 yrs): GMFR (change between 2 timepoints) of SARS-CoV-2 Omicron (BA.4/BA.5) and reference strain neutralizing antibody levels for BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 μg and BNT162b2 30 μg (C4591031 Substudy E). [ Time Frame: From before study vaccination (Day 1) to 1 month after study vaccination. ]
   As measured at the central laboratory.
5. Cohorts 2+3 (18-55 yrs), C2+3 (>55 yrs): % of participants with seroresponse to BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 μg and BNT162b2 30 μg (C4591031 SSE) for GMTs of SARS-CoV-2 Omicron (BA.4/BA.5) and reference strain neutralizing antibody levels. [ Time Frame: At 1 month after study vaccination. ]
   As measured at the central laboratory.

Eligibility Criteria

• Ages Eligible for Study: 12 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

1. Age:

   • Cohort 1: 18 through 55 years of age.
   • Cohort 2: 12 years of age and older.
   • Cohort 3: 18 years of age and older.
   • Cohort 4: 18 through 55 years of age.
2. Willing and able to comply with all scheduled visits/contacts, study procedures and lifestyle considerations.
3. Healthy participants (stable pre-existing disease permitted).
4. Capable of giving signed informed consent.
5. Prior COVID-19 vaccination history:

Cohort 1:

- Received of 1 booster dose of a US-authorized COVID-19 vaccine, with the dose being 90 or more days before first study visit. Documented receipt of all prior COVID-19 vaccines is required.

Cohorts 2 and 3:

- Received 3 prior doses of 30 micrograms BNT162b2, with last dose being 150 to 365 days before first study visit. Documented receipt of all prior COVID-19 vaccines is required.

Cohort 4:

- Received 3 or 4 prior doses of a US-authorized mRNA COVID-19 vaccine (and dose level), with the last dose being a US-authorized Omicron BA.4/BA.5-adapted vaccine and dose level at least 150 days before first study visit. Documented receipt of all prior COVID-19 vaccines is required.

Exclusion Criteria:

1. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study vaccines.
2. Known or suspected immunodeficiency.
3. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
4. Women who are pregnant or breastfeeding.
5. Other medical or psychiatric condition, or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

6. Immunosuppressants/radiotherapy:

   Cohorts 1 and 2: Receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids), or radiotherapy, within 60 days before study vaccination through end of study.

   Cohorts 3 and 4: Receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease), or radiotherapy, within 60 days before enrollment or planned receipt through conclusion of the study.

7. Blood/plasma products, immunoglobulin, or monoclonal antibodies:

   Cohorts 1, 2, 3: Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study vaccination or planned receipt throughout the study.

   Cohort 4: Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies used for treatment/prevention of COVID-19 or those considered immunosuppressive, from 60 days before study vaccination or planned receipt throughout the study.

8. Other study participation:

   Cohorts 1 and 2: Participation in other studies involving a study intervention within 28 days before randomization. Anticipated participation in other studies within 28 days after receipt of study intervention in this study.

   Cohorts 3 and 4: Participation in other studies involving receipt of a study intervention within 28 days before randomization. Anticipated participation in other studies involving a study intervention from randomization through the end of this study.

9. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
10. Cohort 4 only: History of myocarditis or pericarditis

Contacts and Locations

Locations

United States, California

Anaheim Clinical Trials, LLC

Anaheim, California, United States, 92801

California Research Foundation

San Diego, California, United States, 92123

Bayview Research Group, LLC

Valley Village, California, United States, 91607

Diablo Clinical Research, Inc.

Walnut Creek, California, United States, 94598

United States, Connecticut

Clinical Research Consulting

Milford, Connecticut, United States, 06460

United States, Florida

Research Centers of America ( Hollywood )

Hollywood, Florida, United States, 33024

Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

Jacksonville, Florida, United States, 32256

Acevedo Clinical Research Associates

Miami, Florida, United States, 33142

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, Kentucky

Kentucky Pediatric/ Adult Research

Bardstown, Kentucky, United States, 40004

United States, Missouri

Clinical Research Professionals

Chesterfield, Missouri, United States, 63005

Sundance Clinical Research

Saint Louis, Missouri, United States, 63141

United States, Nebraska

Velocity Clinical Research, Omaha

Omaha, Nebraska, United States, 68134

United States, New Jersey

South Jersey Infectious Disease

Somers Point, New Jersey, United States, 08244

United States, New York

Rochester Clinical Research, LLC

Rochester, New York, United States, 14609

United States, North Carolina

Accellacare - Charlotte

Charlotte, North Carolina, United States, 28209

Accellacare - Charlotte

Charlotte, North Carolina, United States, 28211

PharmQuest Life Sciences, LLC

Greensboro, North Carolina, United States, 27408

Accellacare - Wilmington

Wilmington, North Carolina, United States, 28401

United States, Ohio

Senders Pediatrics

Cleveland, Ohio, United States, 44121

Centricity Research Columbus Ohio Multispecialty

Columbus, Ohio, United States, 43213

United States, Oregon

Kaiser Permanente Northwest Center for Health Research

Portland, Oregon, United States, 97227

United States, Tennessee

Clinical Neuroscience Solutions Inc.

Memphis, Tennessee, United States, 38119

Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

Memphis, Tennessee, United States, 38119

United States, Texas

Benchmark Research

Austin, Texas, United States, 78705

Tekton Research, LLC.

Austin, Texas, United States, 78745

DM Clinical Research - Bellaire

Houston, Texas, United States, 77081

IMA Clinical Research San Antonio

San Antonio, Texas, United States, 78229

DM Clinical Research

Tomball, Texas, United States, 77375

United States, Utah

J. Lewis Research, Inc. / Foothill Family Clinic

Salt Lake City, Utah, United States, 84109

J. Lewis Research, Inc. / Foothill Family Clinic South

Salt Lake City, Utah, United States, 84121

United States, Virginia

Virginia Research Center

Midlothian, Virginia, United States, 23114

Sponsors and Collaborators

BioNTech SE

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

• Responsible Party: BioNTech SE
• ClinicalTrials.gov Identifier: NCT05472038
• Other Study ID Numbers: C4591044
• First Posted: July 25, 2022
• Last Update Posted: April 11, 2024
• Last Verified: April 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by BioNTech SE:

SARS-CoV-2 infection; COVID-19

Additional relevant MeSH terms:

COVID-19; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases