NCT00950833

Long-term Follow-up Study of Children Previously Primed With GSK Pneumococcal Vaccine (GSK1024850A) and of Unprimed Children

Vaccination Course in Children Primed and Boosted With Pneumococcal Vaccine GSK 1024850A and in Age-matched Unprimed Children

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 466 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 31 Months – 44 Months
• Healthy volunteers: Accepted

Summary

The objective of this study is to evaluate the immune memory through the administration of an additional dose of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A, the antibody persistence and long-term effect on nasopharyngeal carriage of S. pneumoniae and H. influenzae in subjects primed and boosted with GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A in previous primary and booster studies. For subjects that did not receive the investigational vaccine during the primary and booster study, the objective is to evaluate immunogenicity, safety and reactogenicity of a 2-dose catch-up vaccination with GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A. This protocol posting deals with objectives \& outcome measures of the extension phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT00370318). The objectives \& outcome measures of the booster phase are presented in a separate protocol posting (NCT00496015).

Detailed description

This protocol posting has been updated according to Protocol Amendment 1, July 2009

Conditions

• Infections, Streptococcal

Interventions

Type	Name	Description
BIOLOGICAL	Pneumococcal vaccine GSK1024850A	1 or 2 intramuscular injections

Timeline

• Start date: 2009-08-10
• Primary completion: 2010-09-16
• Completion: 2010-10-27
• First posted: 2009-08-03
• Last updated: 2018-09-20
• Results posted: 2017-08-07

Locations

10 sites across 1 country: Czechia