NCT01030822

Booster and Catch-up Vaccination With Vaccine GSK1024850A

Booster Vaccination With Pneumococcal Vaccine GSK1024850A in Primed Children and Catch-up Vaccination in Unprimed Children

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 282 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 9 Months – 18 Months
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of pneumococcal vaccine GSK1024850A administered either at 9-18 months or 15-18 months of age in children primed in primary study NCT00814710. This study also aims to assess the persistence of antibodies induced following primary vaccination with pneumococcal vaccine GSK1024850A in primary study NCT00814710 prior to booster vaccination and following vaccination in the present study at approximately 24 months of age. The study is also designed to evaluate the immunogenicity, safety and reactogenicity of pneumococcal vaccine GSK1024850A when administered as a catch-up vaccination (2+1) in the second year of life in children unprimed with vaccine GSK1024850A in study NCT00814710.

Detailed description

The study is randomized for primed subjects and non-randomized for unprimed subjects. The protocol posting has been updated according to the amendment of the protocol dated 16 April 2010. The age range at the time of randomization of subjects primed in study NCT00814710 and the age range for booster vaccination of one of the groups has been extended.

Conditions

• Infections, Streptococcal

Interventions

Type	Name	Description
BIOLOGICAL	Pneumococcal vaccine GSK1024850A	Intramuscular injection, administered as a single dose
BIOLOGICAL	Pneumococcal vaccine GSK1024850A	Intramuscular injection, 3 doses

Timeline

• Start date: 2010-04-02
• Primary completion: 2011-08-19
• Completion: 2011-08-19
• First posted: 2009-12-14
• Last updated: 2018-09-20
• Results posted: 2017-02-28

Locations

4 sites across 1 country: India