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20-valent Pneumococcal Conjugate Vaccine Safety Study in Healthy 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: NCT04379713
Recruitment Status : Active, not recruiting
First Posted : May 7, 2020
Last Update Posted : June 3, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE May 6, 2020
First Posted Date  ICMJE May 7, 2020
Last Update Posted Date June 3, 2021
Actual Study Start Date  ICMJE May 21, 2020
Estimated Primary Completion Date September 27, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2020)
  • Percentage of participants reporting prompted local reactions within 7 days after each dose in each group (redness, swelling, and pain at the injection site) [ 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 dose in each group (fever, decreased appetite, irritability, and drowsiness/increased sleep) [ Time Frame: Day 7 ]
    Prompted systemic reactions after each dose in each group
  • Percentage of participants reporting adverse events from Dose 1 through 1 month after Dose 3 in each group [ Time Frame: 1 month after Dose 3 ]
    Adverse events occurring from Dose 1 through 1 month after Dose 3 in each group
  • Percentage of participants reporting adverse events from Dose 4 through 1 month after Dose 4 in each group [ Time Frame: 1 month after Dose 4 ]
    Adverse events occurring from Dose 4 through 1 month after Dose 4 in each group
  • Percentage of participants reporting SAEs up to 6 months after Dose 4 in each group [ Time Frame: 6 months after Dose 4 ]
    SAEs occurring up to 6 months after Dose 4 in each group
  • Percentage of participants reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs) up to 6 months after Dose 4 in each group [ Time Frame: 6 months after Dose 4 ]
    NDCMCs occurring up to 6 months after Dose 4 in each group
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
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 Study in Healthy Infants
Official Title  ICMJE A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS
Brief Summary This study is designed to evaluate the safety and tolerability of 20vPnC 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
    Pneumococcal conjugate vaccine
  • Biological: 13-valent pneumococcal conjugate vaccine
    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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 2, 2021)
1420
Original Estimated Enrollment  ICMJE
 (submitted: May 6, 2020)
1500
Estimated Study Completion Date  ICMJE September 27, 2022
Estimated Primary Completion Date September 27, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female infants born at ≥34 weeks of gestation and who are 2 months of age (≥42 to ≤98 days) at the time of consent (the day of birth is considered day of life 1).
  • Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.

Exclusion Criteria:

  • Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
  • Major known congenital malformation or serious chronic disorder.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 42 Days to 98 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Canada,   Chile,   Czechia,   Finland,   Germany,   Greece,   Hungary,   Puerto Rico,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04379713
Other Study ID Numbers  ICMJE B7471013
2019-003307-35 ( 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 June 2021

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