At a glance
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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
In Brief
A Phase 3 clinical trial evaluating Synflorix, Tritanrix-HepB, and 4 other interventions for Infections, Streptococcal. Completed, enrolled 756 participants across 7 sites in 2 countries.
Detailed 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)
Study Details
Timeline
Interventions
Intramuscular injection, 1 dose
Intramuscular injection, 1 dose
Reconstituted with Tritanrix-Hep B before injection
Oral, 1 dose
Intramuscular injection, 1 dose
Intramuscular injection, 1 dose