Study Evaluating 13-valent Pneumococcal Conjugate Vaccine In Healthy Infants

Completed · Phase 3

Conditions studied: Vaccines, Pneumococcal

In brief

The purpose of this study will be to evaluate safety, tolerability and immunogenicity of three lots of 13-valent pneumococcal vaccine given to healthy infants. Lots will be studied for consistency of the immune response, as well as for non-inferiority and safety as compared to 7-valent Pneumococcal Conjugate Vaccine.

Key facts

Study ID

NCT00444457

Run by

Wyeth is now a wholly owned subsidiary of Pfizer

People needed

1712

Starts

2007-05-01

Expected to finish

2009-06-01

Last updated by the study team

2012-10-15

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy 2 month old infants
• Available for the duration of the study and reachable by telephone
• Able to complete two blood drawing procedures during the study

You may not qualify if…

• Previous vaccination, contraindication or history of allergic reaction to vaccines or vaccine components
• Bleeding disorder, immune deficiency or significant chronic or congenital disease
• Previous receipt of blood products or immune globulin

Where it is running

• Study site — Conway, Arkansas, United States
• Study site — Fayetteville, Arkansas, United States
• Study site — Jonesboro, Arkansas, United States
• Study site — Little Rock, Arkansas, United States
• Study site — North Little Rock, Arkansas, United States
• Study site — Downey, California, United States
• Study site — Fontana, California, United States
• Study site — Fountain Valley, California, United States
• Study site — Lakewood, California, United States
• Study site — Loma Linda, California, United States
• Study site — Moreno Valley, California, United States
• Study site — Paramount, California, United States
• Study site — Riverside, California, United States
• Study site — Rolling Hills Estates, California, United States
• Study site — Boulder, Colorado, United States
• Study site — Longmont, Colorado, United States
• Study site — Norwich, Connecticut, United States
• Study site — Palm Beach Gardens, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Marietta, Georgia, United States
• Study site — Woodstock, Georgia, United States
• Study site — Nampa, Idaho, United States
• Study site — Chicago, Illinois, United States
• Study site — Benton, Arkansas, United States

Full record on ClinicalTrials.gov

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