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Trial record 1 of 1 for:    NCT04382326
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20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants

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ClinicalTrials.gov Identifier: NCT04382326
Recruitment Status : Recruiting
First Posted : May 11, 2020
Last Update Posted : April 19, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE May 7, 2020
First Posted Date  ICMJE May 11, 2020
Last Update Posted Date April 19, 2021
Actual Study Start Date  ICMJE May 20, 2020
Estimated Primary Completion Date September 14, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2020)
  • The percentages of participants reporting prompted local reactions within 7 days after each vaccination in each group [ Time Frame: Day 7 ]
    Prompted local reactions after each dose in each group
  • The percentages of participants reporting prompted systemic events within 7 days after each vaccination in each group [ Time Frame: Day 7 ]
    Prompted systemic reactions after each dose in each group
  • The percentages of participants reporting AEs from Dose 1 to 1 month after Dose 3 in each group [ Time Frame: Dose 1 to 1 month after Dose 3 ]
    Adverse events occurring from Dose 1 to 1 month after Dose 3 in each group
  • The percentages of participants reporting AEs from Dose 4 to 1 month after Dose 4 in each group [ Time Frame: Dose 4 to 1 month after Dose 4 ]
    Adverse events occurring from Dose 4 to 1 month after Dose 4 in each group
  • The percentages of participants reporting SAEs up to 6 months after Dose 4 in each group [ Time Frame: Dose 1 to 6 months after Dose 4 ]
    SAEs occurring up to 6 months after Dose 4 in each group
  • The percentages of participants reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs) up to 6 months after Dose 4 in each group [ Time Frame: Dose 1 to 6 months after Dose 4 ]
    NDCMCs occurring up to 6 months after Dose 4 in each group
  • The percentages of participants with pre-defined pneumococcal IgG concentrations at 1 month after Dose 3 [ Time Frame: 1 month after Dose 3 ]
    IgG concentrations 1 month after Dose 3
  • IgG GMCs 1 month after Dose 4 [ Time Frame: 1 month after Dose 4 ]
    IgG GMCs 1 month after Dose 4
  • The 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2020)
  • IgG GMCs 1 month after Dose 3 [ Time Frame: 1 month after Dose 3 ]
    IgG GMC concentrations 1 month after Dose 3
  • The percentages of participants with predefined pneumococcal IgG concentrations at 1 month after Dose 4 [ Time Frame: 1 month after Dose 4 ]
    IgG concentrations 1 month after Dose 4
  • OPA GMTs at 1 month after Dose 3 in each group [ Time Frame: 1 month after Dose 3 ]
    OPA GMTs 1 month after Dose 3
  • OPA GMTs at 1 month after Dose 4 in each group [ Time Frame: 1 month after Dose 4 ]
    OPA GMTs 1 month after Dose 4
  • IgG GMFRs from 1 month after Dose 3 to before Dose 4 [ Time Frame: From 1 month after Dose 3 to before Dose 4 ]
    IgG GMFRs from 1 month after Dose 3 to before Dose 4
  • IgG GMFRs from 1 month before to 1 month after Dose 4 [ Time Frame: From 1 month before to 1 month after Dose 4 ]
    IgG GMFRs from 1 month before to 1 month after Dose 4
  • IgG GMFRs 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 ]
    IgG GMFRs from 1 month after Dose 3 to 1 month after Dose 4
  • Percentages of participants with pre-specified antibody levels to specific concomitant vaccine antigen 1 month after Dose 3 [ Time Frame: 1 month after Dose 3 ]
    Antibody levels 1 month after Dose 3
  • Ratios of antibody levels for specific concomitant vaccine antigens 1 month after Dose 4 [ Time Frame: 1 month after Dose 4 ]
    Antibody levels 1 month after Dose 4
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants
Official Title  ICMJE A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS
Brief Summary 20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Pneumococcal Disease
Intervention  ICMJE
  • Biological: 20-valent pneumococcal conjugate vaccine
    20-valent pneumococcal conjugate vaccine
  • Biological: 13-valent pneumococcal conjugate vaccine
    13-valent pneumococcal conjugate vaccine
Study Arms  ICMJE
  • Experimental: 20-valent pneumococcal conjugate vaccine
    Pneumococcal conjugate vaccine
    Intervention: Biological: 20-valent pneumococcal conjugate vaccine
  • Active Comparator: 13-valent pneumococcal conjugate vaccine
    Pneumococcal conjugate vaccine
    Intervention: Biological: 13-valent pneumococcal conjugate vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 7, 2020)
2000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 14, 2022
Estimated Primary Completion Date September 14, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  • Previous receipt of >1 dose of hepatitis B vaccine; or receipt of a single hepatitis B vaccine dose administered at >30 days old, or previous receipt of any licensed or investigational pneumococcal vaccine, or planned receipt through study participation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 42 Days to 98 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04382326
Other Study ID Numbers  ICMJE B7471011
2019-003305-10 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP