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Safety and Immunogenicity Study of 20vPnC in Healthy Children 15 Months Through 17 Years of Age | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT04642079•Pfizer

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

1 - 17 years

Sex

ALL

Healthy Volunteers

Yes

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

Locations (43)

Northwest Arkansas Pediatrics

Fayetteville, Arkansas, United States

The Children's Clinic of Jonesboro, P.A.

Jonesboro, Arkansas, United States

The Children's Clinic

Jonesboro, Arkansas, United States

California Research Foundation

San Diego, California, United States

Pharmax Research Clinic, Inc.

Miami, Florida, United States

Bio-Medical Research, LLC

Miami, Florida, United States

Children's Health Center

Tampa, Florida, United States

Tekton Research, Inc

Chamblee, Georgia, United States

Clinical Research Prime

Idaho Falls, Idaho, United States

Meridian Clinical Research, LLC

Sioux City, Iowa, United States

Key Dates

Start Date

December 4, 2020

Primary Completion Date

April 6, 2022

Completion Date

April 6, 2022

Last Updated

January 22, 2024

Enrollment

839

ACTUAL participants

Conditions

Pneumococcal Disease

Interventions

20vPnC

BIOLOGICAL

Carriage to Assess Protection of New Pneumococcal Vaccines - PCV15

NCT06731374

Pneumococcal DiseasePneumococcal Carriage

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RECRUITINGPHASE3

A Clinical Trial to Evaluate the Immunogenicity and Safety of the 23-valent Pneumococcal Polysaccharide Vaccine in Healthy People

NCT06044077

Pneumococcal Disease

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ACTIVE_NOT_RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Carriage to Assess Protection of New Pneumococcal Vaccines - PCV15

A Clinical Trial to Evaluate the Immunogenicity and Safety of the 23-valent Pneumococcal Polysaccharide Vaccine in Healthy People

Phase 2 Trial to Evaluate Safety and Immunogenicity of Inventprise's (IVT) 25-valent Pneumococcal Conjugate Vaccine (IVT PCV-25) in Healthy Infants

Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 50 Years of Age or Older (V116-010, STRIDE-10)

A Study to Learn About How Safe and Effective is 20vPnC and 13vPnC Vaccines in Chinese Adults

20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Pneumococcal Vaccine-Naïve Adults 60 Years of Age and Older in Japan, Korea, and Taiwan