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

NCT04642079

Last updated date
Study Location
Tekton Research, Inc.
Chamblee, Georgia, 30341, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
15-17 months
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Safety and Immunogenicity Study of 20vPnC in Healthy Children 15 Months Through 17 Years of Age
Official Title  ICMJE 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
Brief Summary This study is designed to evaluate the safety and immunogenicity of 20vPnC in healthy children 15 months through 17 years of age
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Pneumococcal Disease
Intervention  ICMJE Biological: 20vPnC
20-valent pneumococcal conjugate vaccine
Study Arms  ICMJE
  • Experimental: Cohort 1: =>15 through 23 months of age
    20vPnC
    Intervention: Biological: 20vPnC
  • Experimental: Cohort 2: 2 through 4 years of age
    20vPnC
    Intervention: Biological: 20vPnC
  • Experimental: Cohort 3: 5 through 9 years of age
    20vPnC
    Intervention: Biological: 20vPnC
  • Experimental: Cohort 4: 10 through 17 years of age
    20vPnC
    Intervention: Biological: 20vPnC
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: November 18, 2020)
800
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2021
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 15 Months to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04642079
Other Study ID Numbers  ICMJE B7471014
2019-003308-11 ( 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/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2020

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