Study Evaluating Prevenar Immunogenicity in High Risk Children

Phase 4

Completed

• Conditions: Vaccines, Pneumococcal Conjugate Vaccine

• Registration Number: NCT00581620
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

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

Detailed 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 Timeline

• Study Start: 2002-11
• Study Completion: 2007-09
• Status Verified: 2007-12
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2007-12-21
• Last Update Submitted: 2007-12-21
• Study First Posted: 2007-12-27
• Last Update Posted: 2007-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Children between 2 months to 9 years old.
• Children with HIV+; Sickle Cell disease; Neprotic symdrome; Chronic pulmonary disease
• No history of seizures

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To determine immunogenicity of the heptavalent CRM197 pneumococcal conjugate in children with immunodeficiency condition	4 months

Secondary Outcome Measures

Name	Time	Method
To evaluate tolerability of Prevenar* in that population.	4 months