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Safety and Immunogenicity Study of 20vPnC in Healthy Children 15 Months Through 17 Years of Age

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ClinicalTrials.gov Identifier: NCT04642079
Recruitment Status : Recruiting
First Posted : November 24, 2020
Last Update Posted : June 18, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
This study is designed to evaluate the safety and immunogenicity of 20vPnC in healthy children 15 months through 17 years of age

Condition or disease Intervention/treatment Phase
Pneumococcal Disease Biological: 20vPnC Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A PHASE 3, SINGLE-ARM TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY CHILDREN 15 MONTHS THROUGH 17 YEARS OF AGE
Actual Study Start Date : December 4, 2020
Estimated Primary Completion Date : December 29, 2021
Estimated Study Completion Date : December 29, 2021

Arm Intervention/treatment
Experimental: Cohort 1: =>15 through 23 months of age
20vPnC
Biological: 20vPnC
20-valent pneumococcal conjugate vaccine

Experimental: Cohort 2: 2 through 4 years of age
20vPnC
Biological: 20vPnC
20-valent pneumococcal conjugate vaccine

Experimental: Cohort 3: 5 through 9 years of age
20vPnC
Biological: 20vPnC
20-valent pneumococcal conjugate vaccine

Experimental: Cohort 4: 10 through 17 years of age
20vPnC
Biological: 20vPnC
20-valent pneumococcal conjugate vaccine




Primary Outcome Measures :
  1. The percentage of participants reporting prompted local reactions within 7 days after vaccination [ Time Frame: Day 7 ]
    Prompted local reactions after vaccination. All cohorts: redness, swelling, and pain at the injection site

  2. The percentage of participants reporting prompted systemic events within 7 days after vaccination [ Time Frame: Day 7 ]
    Prompted systemic events after vaccination. Cohort 1: Fever, decreased appetite, drowsiness/increased sleep, and irritability. Cohorts 2 through 4: Fever, fatigue, headache, muscle pain, and joint pain

  3. The percentage of participants reporting Adverse Events (AEs) up to 1 month after vaccination [ Time Frame: 1 month after vaccination ]
    AEs occurring from vaccination up to 1 month after vaccination

  4. The percentage of participants reporting Serious Adverse Events (SAEs) up to 6 months after vaccination [ Time Frame: 6 months after vaccination ]
    SAEs occurring from vaccination up to 6 months after vaccination

  5. The percentage of participants reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs) up to 6 months after vaccination [ Time Frame: 6 months after vaccination ]
    NDCMCs occurring from vaccination up to 6 months after vaccination

  6. Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 7 additional serotypes 1 month after vaccination [ Time Frame: 1 month after vaccination ]
    IgG GMFRs from before to 1 month after vaccination for Cohorts 1 and 2

  7. Opsonophagocytic activity (OPA) GMFRs for the 7 additional serotypes 1 month after vaccination [ Time Frame: 1 month after vaccination ]
    OPA GMFRs from before to 1 month after vaccination for Cohorts 3 and 4


Secondary Outcome Measures :
  1. IgG Geometric Mean Concentrations (GMCs) for the 20vPnC serotypes before and 1 month after vaccination [ Time Frame: before and 1 month after vaccination ]
    IgG GMCs before and 1 month after vaccination

  2. IgG GMFRs for the 13vPnC serotypes from before to 1 month after vaccination [ Time Frame: before to 1 month after vaccination ]
    IgG GMFRs from before to 1 month after vaccination for Cohorts 1 and 2

  3. OPA Geometric Mean Titers (GMTs) for the 20vPnC serotypes before and 1 month after vaccination [ Time Frame: before and 1 month after vaccination ]
    OPA GMTs before and 1 month after vaccination

  4. OPA GMFRs for the 20vPnC serotypes from before to 1 month after vaccination [ Time Frame: before to 1 month after vaccination ]
    OPA GMFRs from before to 1 month after vaccination in Cohorts 1 and 2

  5. OPA GMFRs for the 13vPnC serotypes from before to 1 month after vaccination [ Time Frame: before to 1 month after vaccination ]
    OPA GMFRs from before to 1 month after vaccination in Cohorts 3 and 4

  6. IgG GMFRs for the 20vPnC serotypes from before to 1 month after vaccination [ Time Frame: before to 1 month after vaccination ]
    IgG GMFRs from before to 1 month after vaccination in Cohorts 3 and 4



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female children ≥15 months to <18 years of age at the time of consent.
  • Healthy children determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
  • For children <5 years of age, written documentation of receipt of at least 3 doses of 13vPnC. The last dose of 13vPnC must have been administered >2 months before enrolment into 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 vaccination with any investigational pneumococcal vaccine or with PPSV23, or planned receipt through study participation
  • Cohorts 3 and 4: Pregnant or breastfeeding female participants

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): NCT04642079


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04642079    
Other Study ID Numbers: B7471014
2019-003308-11 ( EudraCT Number )
First Posted: November 24, 2020    Key Record Dates
Last Update Posted: June 18, 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