NCT00513409

Assess Reacto- and Immunogenicity of Pneumococcal Conjugate Vaccine When Given as Booster or a 2 Dose Catch up Schedule

Phase II, Observer-blind Follow-up Study to Assess reacto-and Immunogenicity of GSK Biologicals' Pneumococcal Conjugate Vaccine (GSK1024850A), When Given as Booster in Primed Children or as 2-dose Catch-up in Unprimed Children.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 163 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Months – 21 Months
• Healthy volunteers: Accepted

Summary

This is a booster study in 2 groups of healthy children less than 3 years old to measure the reactogenicity, safety and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine, when given as a booster or as a two-dose catch-up vaccination. This protocol posting deals with objectives and outcome measures of the booster phase. The objectives and outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00338351).

Detailed description

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

Conditions

• Infections, Streptococcal

Interventions

Type	Name	Description
BIOLOGICAL	Synflorix	Intramuscular injection, 1 or 2 doses
BIOLOGICAL	Infanrix Hexa	1 Intramuscular injection
BIOLOGICAL	Havrix	1 Intramuscular injection

Timeline

• Start date: 2007-08-22
• Primary completion: 2008-02-20
• Completion: 2008-08-28
• First posted: 2007-08-08
• Last updated: 2018-12-19
• Results posted: 2009-08-11

Locations

1 site across 1 country: Chile