Immunogenicity and Safety Study of Pneumococcal 7-Valent Conjugate Vaccine in Sickle Cell Disease Infants.

Phase 4

Terminated

• Conditions: Pneumococcal Infections

• Registration Number: NCT00368186
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

The primary objectives of this study were to assess the immunogenicity and the tolerance of the heptavalent pneumococcal conjugate vaccine (Prevenar) in young infants (2 months of age) with sickle cell disease when administred at 2,3, and 4 months of age.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-05
• Study Completion: 2002-11
• Status Verified: 2006-08
• Study First Submitted: 2006-08-21
• Study First Submitted QC: 2006-08-23
• Last Update Submitted: 2006-08-23
• Study First Posted: 2006-08-24
• Last Update Posted: 2006-08-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Antibody responses to pneumococcal capsular polysaccharides antigens contained in PCV7 vaccine; local and systemic reactions.

Secondary Outcome Measures

Name	Time	Method
Opsonophagocytic activity; S. pneumoniae nasopharyngeal carriage.