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Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

Vaccines, Pneumococcal Clinical Trial

Official title:
A Phase 3, Randomized, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine Manufactured With and Without Polysorbate 80 in Healthy Infants Given in a 2-, 3-, 4-, and 12-Month Schedule With Routine Pediatric Vaccinations

Clinical Trial Summary

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine manufactured with Polysorbate 80 compared to a 13-valent pneumococcal conjugate (13vPnC) manufactured without Polysorbate 80 when given concomitantly with routine paediatric vaccinations.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00366548
Study type Interventional
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact
Status Completed
Phase Phase 3
Start date November 2006
Completion date June 2008
View Details
See also
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Completed NCT00366899 - Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Infants Phase 3
Completed NCT00366678 - 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 NCT00366340 - Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants. Phase 3
Completed NCT00444457 - Study Evaluating 13-valent Pneumococcal Conjugate Vaccine In Healthy 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
Completed NCT01086397 - Epidemiologic Study Of The Distribution Of Vaccine-Type Streptococcus Pneumoniae Serotypes In Adults In The US With Community-Acquired Pneumonia N/A