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Study Evaluating 13-valent Pneumococcal Conjugate Vaccine In Healthy Infants

Vaccines, Pneumococcal Clinical Trial

Official title:
A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of Three Lots of 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in the United States

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00444457
Study type Interventional
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact
Status Completed
Phase Phase 3
Start date May 2007
Completion date June 2009
View Details
See also
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Completed NCT00366340 - Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants. Phase 3
Completed NCT00368966 - Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants. Phase 3
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Completed NCT00708682 - Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants in Mexico Phase 3
Completed NCT00474539 - Study Evaluating a 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants Phase 3
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