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

Completed · Phase 3

Conditions studied: Healthy Subjects

In brief

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.

Key facts

Study ID

NCT00761631

Run by

Pfizer

People needed

1200

Starts

2008-11-18

Expected to finish

2010-08-10

Last updated by the study team

2026-07-21

Who can join

Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Central Arkansas Pediatric Clinic — Benton, Arkansas, United States
• Northwest Arkansas Pediatric Clinic — Fayetteville, Arkansas, United States
• The Children's Clinic of Jonesboro, PA — Jonesboro, Arkansas, United States
• Arkansas Pediatric Clinic — Little Rock, Arkansas, United States
• Little Rock Children's Clinic, PA — Little Rock, Arkansas, United States
• Edinger Medical Group — Fountain Valley, California, United States
• Loma Linda University — Loma Linda, California, United States
• Loma Linda University — Loma Linda, California, United States
• UCLA School of Medicine - Center for Vaccine Research — Torrance, California, United States
• USF College of Medicine — Tampa, Florida, United States
• Pediatric and Adolescent Medicine, PA — Marietta, Georgia, United States
• Pediatric and Adolescent Medicine, PA — Woodstock, Georgia, United States
• Northern Illinois Research Associates — DeKalb, Illinois, United States
• Pediatric Infectious Diseases — Louisville, Kentucky, United States
• Pediatric Infectious Diseases — Louisville, Kentucky, United States
• Aspen Medical Group — Saint Paul, Minnesota, United States
• Primary Care Pediatric Clinic — Lebanon, New Hampshire, United States
• Hunterdon Pediatrics Associates — Whitehouse Station, New Jersey, United States
• Elmwood Pediatric Group — Rochester, New York, United States
• Cary Pediatric Center — Cary, North Carolina, United States
• MedCenter One/ Q&R Clinic — Bismarck, North Dakota, United States
• Dakota Clinicl / Innovis Hospital — Fargo, North Dakota, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Shelly Senders & Associates — Cleveland, Ohio, United States
• Oklahoma State University Center for Health — Tulsa, Oklahoma, United States

Full record on ClinicalTrials.gov

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