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20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series in Healthy Infants

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ClinicalTrials.gov Identifier: NCT04546425
Recruitment Status : Active, not recruiting
First Posted : September 14, 2020
Last Update Posted : October 13, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series in Healthy 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 : 1200 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 TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE GIVEN AS A SERIES OF 2 INFANT DOSES AND 1 TODDLER DOSE IN HEALTHY INFANTS
Actual Study Start Date : September 9, 2020
Estimated Primary Completion Date : April 22, 2022
Estimated Study Completion Date : April 27, 2023

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 20-valent pneumococcal conjugate vaccine
Pneumococcal conjugate vaccine
 Biological: 20-valent pneumococcal conjugate vaccine
20-valent pneumococcal conjugate vaccine
Active Comparator: 13-valent pneumococcal conjugate vaccine
Pneumococcal conjugate vaccine
 Biological: 13-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of participants reporting prompted local reactions within 7 days after each vaccination in each vaccine group [ Time Frame: Day 7 ]
    Prompted local reactions after each dose in each group

  2. Percentage of participants reporting prompted systemic events within 7 days after each vaccination in each vaccine group [ Time Frame: Day 7 ]
    Prompted systemic reactions after each dose in each group

  3. Percentage of participants reporting adverse events (AEs) from Dose 1 to 1 month after Dose 2 in each vaccine group [ Time Frame: Dose 1 to 1 month after Dose 2 ]
    AEs occurring from Dose 1 to 1 month after Dose 2 in each group

  4. Percentage of participants reporting AEs from Dose 3 to 1 month after Dose 3 in each vaccine group [ Time Frame: Dose 3 to 1 month after Dose 3 ]
    AEs occurring from Dose 3 to 1 month after Dose 3 in each group

  5. Percentage of participants reporting serious adverse events (SAEs) during the study in each vaccine group [ Time Frame: Dose 1 to 1 month after Dose 3 ]
    SAEs occurring from Dose 1 to 1 month after Dose 3 in each group

  6. Percentage of participants reporting newly diagnosed chronic medical conditions (NDCMC) during the study in each vaccine group [ Time Frame: Dose 1 to 1 month after Dose 3 ]
    NDCMCs occurring from Dose 1 to 1 month after Dose 3 in each group

  7. Percentages of participants with predefined pneumococcal serotype-specific IgG concentrations at 1 month after Dose 2 [ Time Frame: 1 month after Dose 2 ]
    IgG concentrations at 1 month after Dose 2

  8. Geometric mean concentrations (GMCs) of serotype-specific IgG concentrations 1 month after Dose 2 [ Time Frame: 1 month after Dose 2 ]
    IgG GMCs 1 month after Dose 2

  9. Geometric mean concentrations (GMCs) of serotype-specific IgG concentrations 1 month after Dose 3 [ Time Frame: 1 month after Dose 3 ]
    IgG GMCs 1 month after Dose 3

  10. Percentages of participants with prespecified antibody levels to specific concomitant vaccine antigens 1 month after Dose 3 [ Time Frame: 1 month after Dose 3 ]
    Antibody levels 1 month after Dose 3


Secondary Outcome Measures :
  1. Percentages of participants with the predefined serotype-specific IgG concentrations 1 month after Dose 3 in each vaccine group [ Time Frame: 1 month after Dose 3 ]
    IgG concentrations 1 month after Dose 3

  2. Opsonophagocytic activity (OPA) GMTs 1 month after Dose 2 in each vaccine group [ Time Frame: 1 month after Dose 2 ]
    OPA GMTs 1 month after Dose 2

  3. Opsonophagocytic activity (OPA) GMTs 1 month after Dose 3 in each vaccine group [ Time Frame: 1 month after Dose 3 ]
    OPA GMTs 1 month after Dose 3

  4. IgG GMFRs from before Dose 3 to 1 month after Dose 3 in each vaccine group [ Time Frame: Before Dose 3 to 1 month after Dose 3 ]
    IgG GMFRs before Dose 3 to 1 month after Dose 3

  5. Antibody levels to specific concomitant vaccine antigens 1 month after Dose 2 [ Time Frame: 1 month after Dose 2 ]
    Antibody levels 1 month after Dose 2


Eligibility Criteria
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Ages Eligible for Study:   42 Days to 112 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female infants born at >36 weeks of gestation and 2 months of age 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.
  • 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.
  • Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
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): NCT04546425


Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04546425    
Other Study ID Numbers: B7471012
2019-003306-27 ( EudraCT Number )
First Posted: September 14, 2020    Key Record Dates
Last Update Posted: October 13, 2021
Last Verified: October 2021
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
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