NCT01027845

Primary and Booster Vaccination Study With Pneumococcal Vaccine GSK1024850A in Healthy Japanese Children

Immunogenicity, Safety and Reactogenicity of GlaxoSmithKline Biologicals' Pneumococcal Vaccine GSK1024850A Following Primary and Booster Vaccination of Healthy Japanese Children

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 90 Days – 118 Days
• Healthy volunteers: Accepted

Summary

This study will aim to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' 10-valent pneumococcal conjugate vaccine GSK1024850A when co-administered with Japanese DTPa vaccine as a 3-dose primary immunization course in healthy Japanese children at 3, 4 and 5 months of age and as a booster vaccination at 17-19 months of age.

Conditions

• Infections, Streptococcal

Interventions

Type	Name	Description
BIOLOGICAL	Pneumococcal vaccine GSK1024850A	Intramuscular injection, 4 doses
BIOLOGICAL	DTPa	Subcutaneous injection, 4 doses

Timeline

• Start date: 2009-12-08
• Primary completion: 2010-08-13
• Completion: 2011-09-17
• First posted: 2009-12-09
• Last updated: 2019-11-29
• Results posted: 2019-11-29

Locations

16 sites across 1 country: Japan