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

NCT04642079

CompletedPhase 3

Sponsor: Pfizer

Conditions: Pneumococcal Disease

Interventions: 20vPnC

Countries: United States

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

Eligibility overview

Sex: ALL

Age: 15 Months to 17 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility 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
Locations (43)
  • Fayetteville, Arkansas, United States
  • Jonesboro, Arkansas, United States
  • Jonesboro, Arkansas, United States
  • San Diego, California, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Tampa, Florida, United States
  • Chamblee, Georgia, United States
  • Idaho Falls, Idaho, United States
  • Sioux City, Iowa, United States
  • Newton, Kansas, United States
  • Bardstown, Kentucky, United States
  • Lexington, Kentucky, United States
  • Gulfport, Mississippi, United States
  • Grand Island, Nebraska, United States
  • Lincoln, Nebraska, United States
  • Lincoln, Nebraska, United States
  • Norfolk, Nebraska, United States
  • Omaha, Nebraska, United States
  • Omaha, Nebraska, United States
  • Henderson, Nevada, United States
  • Albuquerque, New Mexico, United States
  • Binghamton, New York, United States
  • Dayton, Ohio, United States
  • Dayton, Ohio, United States
  • Dayton, Ohio, United States
  • Erie, Pennsylvania, United States
  • Fort Washington, Pennsylvania, United States
  • North Charleston, South Carolina, United States
  • Austin, Texas, United States
  • + 13 more on CT.gov