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

Completed · Phase 3

Conditions studied: Pneumococcal Disease

In brief

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

Key facts

Study ID

NCT04642079

Run by

Pfizer

People needed

839

Starts

2020-12-04

Expected to finish

2022-04-06

Last updated by the study team

2024-01-22

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Alliance for Multispecialty Research, LLC — Newton, Kansas, United States
• Kentucky Pediatric/ Adult Research — Bardstown, Kentucky, United States
• Michael W. Simon, M.D., PSC — Lexington, Kentucky, United States
• MedPharmics, LLC — Gulfport, Mississippi, United States
• Velocity Clinical Research, Grand Island — Grand Island, Nebraska, United States
• Midwest Children's Health Research Institute — Lincoln, Nebraska, United States
• Midwest Children's Health Research Institute — Lincoln, Nebraska, United States
• Velocity Clinical Research, Norfolk — Norfolk, Nebraska, United States
• Meridian Clinical Research, LLC — Omaha, Nebraska, United States
• Velocity Clinical Research, Sioux City — Omaha, Nebraska, United States
• Wr-Crcn, Llc — Henderson, Nevada, United States
• MedPharmic's, LLC — Albuquerque, New Mexico, United States
• Meridian Clinical Research, LLC — Binghamton, New York, United States
• Dayton Clinical Research — Dayton, Ohio, United States
• Ohio Pediatric Research Association Inc. — Dayton, Ohio, United States

Full record on ClinicalTrials.gov

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