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Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Healthy Children Aged 15 Months to 17 Years
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Healthy Children Aged 15 Months to 17 Years

NCT00761631

CompletedPhase 3

Sponsor: Pfizer

Conditions: Healthy Subjects

Interventions: 13 valent pneumococcal conjugate vaccine

Countries: United States

This open-label, multicenter study is designed to evaluate the safety, tolerability and immunogenicity of 13-valent pneumococcal conjugate vaccine in healthy children aged more than 15 months up to less than 18 years.

Eligibility overview

Sex: ALL

Age: 15 Months to 18 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Male or female subjects \>15months to \<18years in good health, available for entire study period and reachable by phone, parents/legal guardian able and willing to complete all study procedures, written documentation from health professional showing prior vaccination with Prevnar (except for group 4).

Group 4 only:

* Negative urine pregnancy test for female subjects who are menstruating.

Exclusion Criteria:

* Previous reaction or contra-indication to pneumococcal vaccine or vaccine related component , bleeding diathesis, received blood transfusion or blood related products, immune deficiency,congenital malformation.

Group 4 only:

* Previous vaccination with Prevnar or any other pneumococcal vaccine.
* Pregnant or breastfeeding adolescent females.
Locations (36)
  • Benton, Arkansas, United States
  • Fayetteville, Arkansas, United States
  • Jonesboro, Arkansas, United States
  • Little Rock, Arkansas, United States
  • Little Rock, Arkansas, United States
  • Fountain Valley, California, United States
  • Loma Linda, California, United States
  • Loma Linda, California, United States
  • Torrance, California, United States
  • Tampa, Florida, United States
  • Marietta, Georgia, United States
  • Woodstock, Georgia, United States
  • DeKalb, Illinois, United States
  • Louisville, Kentucky, United States
  • Louisville, Kentucky, United States
  • Saint Paul, Minnesota, United States
  • Lebanon, New Hampshire, United States
  • Whitehouse Station, New Jersey, United States
  • Rochester, New York, United States
  • Cary, North Carolina, United States
  • Bismarck, North Dakota, United States
  • Fargo, North Dakota, United States
  • Cincinnati, Ohio, United States
  • Cleveland, Ohio, United States
  • Tulsa, Oklahoma, United States
  • Philadelphia, Pennsylvania, United States
  • Clarksville, Tennessee, United States
  • Galveston, Texas, United States
  • San Antonio, Texas, United States
  • Murray, Utah, United States
  • + 6 more on CT.gov