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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, Active-Controlled, Double-blind Trial of the Safety, Tolerability, and Immunologic Non-Inferiority of a 13-valent Pneumococcal Conjugate Vaccine Compared to a 7-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in Germany.

Clinical Trial Summary

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to 7-valent pneumococcal conjugate (Prevenar/Prevenar®, 7vPnC), when given concomitantly with Infanrix hexa at 2, 3, 4, months (infant series) and at 11-12 months of age (toddler dose) in Germany.

Clinical Trial Description

n/a

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00366340
Study type Interventional
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact
Status Completed
Phase Phase 3
Start date October 2006
Completion date August 2008
View Details
See also
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Completed NCT00580684 - Study Comparing Prevenar® to Pneumo 23 in Reducing Carriage in Children Phase 4
Completed NCT00366678 - Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants Phase 3
Completed NCT00384059 - 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 NCT00366548 - 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
Completed NCT00294294 - Study Evaluating Treatment of Fever in Children Who Have Been Vaccinated With Prevenar and Infanrix Hexa Phase 4
Completed NCT00708682 - Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants in Mexico Phase 3
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