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Pneumococcal Vaccine Booster Study in Healthy Children 12-18 Mths Old Previously Primed With the Same Vaccines

Infections, Streptococcal Clinical Trial

Official title:
Booster Vaccination Course With the Pneumococcal Vaccine GSK 1024850A, DTPw-HBV/Hib and OPV or IPV in Children Who Completed the Primary Vaccination Course in Study 107007

Clinical Trial Summary

The purpose of this observer blind study is to assess the safety in terms of fever >39°C (rectal temperature) and the immunogenicity in terms of antibody response following a booster vaccination with pneumococcal vaccine GSK 1024850A at 12 to 18 months of age in children previously primed with the same vaccines including a pneumococcal conjugate vaccine co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined vaccine and OPV or IPV vaccines. Subjects participating in this study should have received three doses of pneumococcal conjugate vaccine in the primary study.

This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00344318)

Clinical Trial Description

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00547248
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 3
Start date October 22, 2007
Completion date October 7, 2008
View Details
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