At a glance
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Immunogenicity, Safety and Reactogenicity Study of GSK Biologicals' Pneumococcal Vaccine (Synflorix™) When Administered to Children Who Are at an Increased Risk of Pneumococcal Infection
In Brief
A Phase 3 clinical trial evaluating Synflorix™ for Infections, Streptococcal and Streptococcus Pneumoniae Vaccines. Completed, enrolled 52 participants across 6 sites in 2 countries.
Detailed Summary
The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of GSK Biologicals' 10Pn-PD-DiT vaccine in children aged between 2 and 17 years of age having asplenia, splenic dysfunction or complement deficiencies. In addition, this study will include an age-matched control group of healthy children aged 24-59 months in order to descriptively compare the immunogenicity of 10Pn-PD-DiT vaccine in the at-risk population to that of the general, healthy population one month after each pneumococcal vaccination.
Study Details
Timeline
Interventions
1 or 2 doses depending on the priming status, intramuscularly in the non-dominant deltoid muscle or the thigh.