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Study Evaluating a 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 a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With a Meningococcal C-Tetanus Toxoid Conjugate Vaccine and Other Routine Pediatric Vaccinations in Spain

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 Prevenar (7vPnC), when given concomitantly with routine paediatric vaccinations in Spain.

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 NCT00474539
Study type Interventional
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact
Status Completed
Phase Phase 3
Start date July 2007
Completion date March 2009
View Details
See also
  Status Clinical Trial Phase
Completed NCT00373958 - Study Comparing 13-valent Pneumococcal Conjugate Vaccine With 7-valent Pneumococcal Conjugate Vaccine Phase 3
Completed NCT00580684 - Study Comparing Prevenar® to Pneumo 23 in Reducing Carriage in Children Phase 4
Completed NCT00368966 - Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants. Phase 3
Completed NCT00366899 - Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Infants Phase 3
Completed NCT00366340 - 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 NCT00366678 - Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants Phase 3
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
Completed NCT01086397 - Epidemiologic Study Of The Distribution Of Vaccine-Type Streptococcus Pneumoniae Serotypes In Adults In The US With Community-Acquired Pneumonia N/A