NCT01746108

Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Pneumococcal Vaccine (Synflorix™) When Administered to Children Who Are at an Increased Risk of Pneumococcal Infection

Immunogenicity, Safety and Reactogenicity Study of GSK Biologicals' Pneumococcal Vaccine (Synflorix™) When Administered to Children Who Are at an Increased Risk of Pneumococcal Infection

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Accepted

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.

Detailed description

The protocol has been amended to clarify the definition of priming status to consider for inclusion of subjects in the primed groups.

Conditions

• Infections, Streptococcal
• Streptococcus Pneumoniae Vaccines

Interventions

Type	Name	Description
BIOLOGICAL	Synflorix™	1 or 2 doses depending on the priming status, intramuscularly in the non-dominant deltoid muscle or the thigh.

Timeline

• Start date: 2013-06-18
• Primary completion: 2015-06-29
• Completion: 2015-06-29
• First posted: 2012-12-10
• Last updated: 2019-07-09
• Results posted: 2017-01-09

Locations

6 sites across 2 countries: Poland, Russia