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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 : Recruiting
First Posted : September 14, 2020
Last Update Posted : April 19, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE August 21, 2020
First Posted Date  ICMJE September 14, 2020
Last Update Posted Date April 19, 2021
Actual Study Start Date  ICMJE September 9, 2020
Estimated Primary Completion Date March 22, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2020)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Percentages of participants with predefined pneumococcal serotype-specific IgG concentrations at 1 month after Dose 3 [ Time Frame: 1 month after Dose 3 ]
    IgG concentrations at 1 month after Dose 3
  • 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
  • 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: September 4, 2020)
  • 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
  • Percentages of participants with the predefined serotype-specific IgG concentration 1 month after Dose 2 in each vaccine group [ Time Frame: 1 month after Dose 2 ]
    IgG concentration 1 month after Dose 2
  • IgG GMCs 1 month after Dose 2 in each vaccine group [ Time Frame: 1 month after Dose 2 ]
    IgG GMCs 1 month after Dose 2
  • 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
  • Opsonophagocytic activity (OPA) GMTs before Dose 3 in each vaccine group [ Time Frame: approximately 7 months after Dose 2 ]
    OPA GMTs before Dose 3
  • 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
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 3-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 GIVEN AS A SERIES OF 2 INFANT DOSES AND 1 TODDLER DOSE IN HEALTHY INFANTS
Brief Summary 20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-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: September 4, 2020)
1200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 22, 2022
Estimated Primary Completion Date March 22, 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 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 42 Days to 112 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 Australia,   Belgium,   Czechia,   Denmark,   Estonia,   Finland,   Italy,   Netherlands,   Norway,   Poland,   Slovakia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04546425
Other Study ID Numbers  ICMJE B7471012
2019-003306-27 ( 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