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Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants

Vaccines, Pneumococcal Conjugate Vaccine 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 Routine Pediatric Vaccinations in Canada

Clinical Trial Summary

The purpose of this study will be to evaluate the safety, tolerability and immunogenicity of 13-valent pneumococcal conjugate vaccine in healthy infants given with routine pediatric vaccinations in Canada. Immune responses induced by the infant series (NeisVac-C® and Pentacel®)and toddler dose(NeisVac-C®)of routine pediatric vaccines when administered with 13-valent pneumococcal conjugate vaccine will be studied for noninferiority to the immune responses when administered with 7-valent pneumococcal conjugate vaccine. Safety profile and immunogenicity of 13-valent pneumococcal conjugate vaccine will also be evaluated.

Clinical Trial Description

n/a

Study Design

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

Related Conditions & MeSH terms

  • Vaccines, Pneumococcal Conjugate Vaccine
Clinical Trial Details
NCT number NCT00475033
Study type Interventional
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact
Status Completed
Phase Phase 3
Start date June 2007
Completion date May 2009
View Details
See also
  Status Clinical Trial Phase
Completed NCT00574795 - Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Japanese Infants Phase 3
Completed NCT00269672 - Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Elderly Subjects Phase 2
Completed NCT00580684 - Study Comparing Prevenar® to Pneumo 23 in Reducing Carriage in Children Phase 4
Completed NCT00500357 - Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Elderly Subjects Phase 3
Completed NCT00581620 - Study Evaluating Prevenar Immunogenicity in High Risk Children Phase 4
Completed NCT00980655 - Study to Evaluate 13 Valent Pneumococcal Conjugate Vaccine (13vPnC) Vaccine Followed by 23-valent Pneumococcal Polysaccharide Vaccine (23vPS) Vaccine in Allogeneic Hematopoietic Stem Cell Transplant Recipients Phase 3
Completed NCT00676091 - Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in Brazil Phase 3
Completed NCT00683410 - Post-Marketing Study of the Safety of Prevenar (Pneumococcal Conjugate Vaccine, 7-valent) N/A