At a glance
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Safety, Reactogenicity and Immunogenicity Following Booster Dose of GSK Biologicals´ Pneumococcal Conjugate Vaccine When Co-administered With a Booster Dose of Infanrix-IPV/Hib in Preterm Born Children at 16-18 Months of Age
In Brief
A Phase 3 clinical trial evaluating GSK Biologicals´ Pneumococcal Conjugate Vaccine (GSK1024850A) and Infanrix™-IPV/Hib for Infections, Streptococcal and Streptococcus Pneumoniae Vaccines. Completed, enrolled 245 participants across 7 sites in 2 countries.
Detailed Summary
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a booster dose of GlaxoSmithKline (GSK) Biologicals´ pneumococcal conjugate vaccine co-administered with a booster dose of DTPa-IPV/Hib (Infanrix-IPV/Hib) in preterm born children at the age of 16-18 months. 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 =NCT00390910 ). Subjects participating in this study should have received three doses of pneumococcal vaccine in the primary study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study Details
Timeline
Interventions
Single dose, intramuscular injection
Single dose, intramuscular injection