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20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04530838
Recruitment Status : Completed
First Posted : August 28, 2020
Results First Posted : April 21, 2023
Last Update Posted : April 21, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese Infants

Condition or disease Intervention/treatment Phase
Pneumococcal Disease Biological: 20-valent pneumococcal conjugate vaccine Biological: 13-valent pneumococcal conjugate vaccine Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 668 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, THIRD PARTY UNBLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY JAPANESE INFANTS
Actual Study Start Date : September 16, 2020
Actual Primary Completion Date : April 2, 2022
Actual Study Completion Date : April 2, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arms and Interventions
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Arm Intervention/treatment
Experimental: 20-valent pneumococcal conjugate vaccine (subcutaneous)
20-valent pneumococcal conjugate vaccine administered by subcutaneous injection (SC)
 Biological: 20-valent pneumococcal conjugate vaccine
20-valent pneumococcal conjugate vaccine
Active Comparator: 13-valent pneumococcal conjugate vaccine (subcutaneous)
13-valent pneumococcal conjugate vaccine administered by subcutaneous injection (SC)
 Biological: 13-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine
Experimental: 20-valent pneumococcal conjugate vaccine (intramuscular)
20-valent pneumococcal conjugate vaccine administered by intramuscular injection (IM)
 Biological: 20-valent pneumococcal conjugate vaccine
20-valent pneumococcal conjugate vaccine


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1 [ Time Frame: Within 7 Days after Dose 1 ]
    Local reactions included pain at injection site, redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 centimeter (cm). Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Redness and swelling were graded as mild: >0 to 2.0 cm; moderate >2.0 to 7.0 cm; and severe: >7.0 cm.

  2. Percentage of Participants With Local Reactions Within 7 Days After Dose 2 [ Time Frame: Within 7 Days after Dose 2 ]
    Local reactions included pain at injection site, redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Redness and swelling were graded as mild: >0 to 2.0 cm; moderate >2.0 to 7.0 cm; and severe: >7.0 cm.

  3. Percentage of Participants With Local Reactions Within 7 Days After Dose 3 [ Time Frame: Within 7 Days after Dose 3 ]
    Local reactions included pain at injection site, redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Redness and swelling were graded as mild: >0 to 2.0 cm; moderate >2.0 to 7.0 cm; and severe: >7.0 cm.

  4. Percentage of Participants With Local Reactions Within 7 Days After Dose 4 [ Time Frame: Within 7 Days after Dose 4 ]
    Local reactions included pain at injection site, redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Redness and swelling were graded as mild: >0 to 2.0 cm; moderate >2.0 to 7.0 cm; and severe: >7.0 cm.

  5. Percentage of Participants With Systemic Events Within 7 Days After Dose 1 [ Time Frame: Within 7 Days After Dose 1 ]
    Systemic events included fever, decreased appetite, drowsiness and irritability. Fever was defined as an axillary temperature greater than or equal to (>=) 37.5 degree Celsius (C), and categorized as >=37.5 to 38.4 degree C, greater than (>)38.4 to 38.9 degree C,>38.9 to 40.0 degree C and >40.0 degree C; decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed); drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity); Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).

  6. Percentage of Participants With Systemic Events Within 7 Days After Dose 2 [ Time Frame: Within 7 Days After Dose 2 ]
    Systemic events included fever, decreased appetite, drowsiness and irritability. Fever was defined as an axillary temperature >=37.5 degree C and categorized as >=37.5 to 38.4 degree C,>38.4 to 38.9 degree C,>38.9 to 40.0 degree C and >40.0 degree C; decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed); drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity); Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).

  7. Percentage of Participants With Systemic Events Within 7 Days After Dose 3 [ Time Frame: Within 7 Days After Dose 3 ]
    Systemic events included fever, decreased appetite, drowsiness and irritability. Fever was defined as an axillary temperature >=37.5 degree C and categorized as >=37.5 to 38.4 degree C,>38.4 to 38.9 degree C,>38.9 to 40.0 degree C and >40.0 degree C; decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed); drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity); Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).

  8. Percentage of Participants With Systemic Events Within 7 Days After Dose 4 [ Time Frame: Within 7 Days After Dose 4 ]
    Systemic events included fever, decreased appetite, drowsiness and irritability. Fever was defined as an axillary temperature >=37.5 degree C and categorized as >=37.5 to 38.4 degree C,>38.4 to 38.9 degree C,>38.9 to 40.0 degree C and >40.0 degree C; decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed); drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity); Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).

  9. Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3 [ Time Frame: Day 1 of Dose 1 to 1 Month after Dose 3 ]
    An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

  10. Percentage of Participants With AEs From Dose 4 to 1 Month After Dose 4 [ Time Frame: From Dose 4 to 1 Month after Dose 4 ]
    An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

  11. Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 4 [ Time Frame: From Dose 1 to 1 Month after Dose 4 ]
    A serious AE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; congenital anomaly/birth defect and other important medical events.

  12. Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Dose 1 to 1 Month After Dose 4 [ Time Frame: From Dose 1 to 1 Month after Dose 4 ]
    An NDCMC was defined as a significant disease or medical condition, not previously identified, that is expected to be persistent or was otherwise long-lasting in its effects.

  13. Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 [ Time Frame: 1 Month after Dose 3 ]
    Pneumococcal serotype-specific IgG Concentrations were measured for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. Assay results below the lower limit of quantitation (LLOQ) were set to 0.5*LLOQ. The predefined levels, >=0.35 micrograms/mL for all serotypes except for serotypes 5 (>=0.23 micrograms/mL), 6B (>=0.10 micrograms/mL) and 19A (>=0.12 micrograms/mL).


Secondary Outcome Measures :
  1. Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 [ Time Frame: 1 Month after Dose 3 ]
    Pneumococcal serotype-specific IgG concentrations were measured for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. Assay results below the LLOQ were set to 0.5*LLOQ.

  2. Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 [ Time Frame: 1 Month after Dose 4 ]
    Pneumococcal serotype-specific IgG concentrations were measured for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F.

  3. Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 [ Time Frame: 1 Month after Dose 3, before Dose 4 and 1 Month after Dose 4 ]
    20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. OPA titers were determined in randomly selected subsets of sera from each vaccine group.

  4. Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 [ Time Frame: 1 Month after Dose 4 ]
    Pneumococcal serotype-specific IgG concentrations were measured for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. The predefined levels, >=0.35 micrograms/mL for all serotypes except for serotypes 5 (>=0.23 micrograms/mL), 6B (>=0.10 micrograms/mL) and 19A (>=0.12 micrograms/mL).

  5. Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 [ Time Frame: 1 Month after Dose 3 to before Dose 4 ]
    GMFR of pneumococcal 20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. The GMFR from 1 month after Dose 3 to before Dose 4 was reported from participants in Dose 3 evaluable immunogenicity population.

  6. GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 [ Time Frame: From 1 Month after Dose 3 to 1 Month after Dose 4 ]
    GMFR of pneumococcal 20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. The GMFR from 1 month after Dose 3 to 1 month after Dose 4 was reported from participants in both the Dose 3 and Dose 4 evaluable immunogenicity population.

  7. GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 [ Time Frame: From before Dose 4 to 1 Month after Dose 4 ]
    GMFR of pneumococcal 20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. The GMFR from before Dose 4 to 1 month after Dose 4 was reported from participants in the Dose 4 evaluable immunogenicity population.


Eligibility Criteria
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Ages Eligible for Study:   2 Months to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Japanese male or female infants ≥2 months to ≤6 months at the time of consent.
  • Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.

Exclusion Criteria:

  • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis)
  • Major known congenital malformation or serious chronic disorder.
  • History of microbiologically proven invasive disease caused by S pneumoniae.
  • Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04530838


Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
  Study Documents (Full-Text)

Documents provided by Pfizer:
Study Protocol  [PDF] June 9, 2020
Statistical Analysis Plan  [PDF] June 9, 2022

More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04530838    
Other Study ID Numbers: B7471016
2022-001146-38 ( EudraCT Number )
First Posted: August 28, 2020    Key Record Dates
Results First Posted: April 21, 2023
Last Update Posted: April 21, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
 Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs