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Study Evaluating Prevenar Immunogenicity in High Risk Children

Vaccines, Pneumococcal Conjugate Vaccine Clinical Trial

Official title:
To Evaluate the Humoral Immune Response to a Conjugated Pneumococcus Vaccine 7-Valent (Prevenar®) in Children From High Risk Groups.

Clinical Trial Summary

To determine immunogenicity of the heptavalent CRM197 pneumococcal conjugate in children with immunodeficiency condition. To evaluate tolerability of Prevenar® in that population.

Clinical Trial Description

This study will require 24 months to be completed. Each child will participate for a period of time according to age of the 1st dose of vaccination: infants up to 6 months of age will be evaluated for 5 months; infants between 7 to 11 months will be evaluated for 3 months; children between 12 months up to 9 years of age will be evaluate for 2 months ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

  • Vaccines, Pneumococcal Conjugate Vaccine
Clinical Trial Details
NCT number NCT00581620
Study type Interventional
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact
Status Completed
Phase Phase 4
Start date November 2002
Completion date September 2007
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 NCT00475033 - Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Phase 3
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