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20-valent Pneumococcal Conjugate Vaccine Safety Study in Healthy Infants

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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

Study Description
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Brief Summary:
This study is designed to evaluate the safety and tolerability of 20vPnC 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 : 1420 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 OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS
Actual Study Start Date : May 21, 2020
Estimated Primary Completion Date : September 27, 2022
Estimated Study Completion Date : September 27, 2022

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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
Pneumococcal conjugate vaccine
Active Comparator: 13-valent pneumococcal conjugate vaccine
Pneumococcal conjugate vaccine
 Biological: 13-valent pneumococcal conjugate vaccine
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 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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


Eligibility Criteria
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Ages Eligible for Study:   42 Days to 98 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
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): NCT04379713


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: NCT04379713    
Other Study ID Numbers: B7471013
2019-003307-35 ( EudraCT Number )
First Posted: May 7, 2020    Key Record Dates
Last Update Posted: June 3, 2021
Last Verified: June 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
 Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs