NCT01175083

Immunization of Children Between 8 Weeks and 2 Years of Age With GSK Pneumococcal Vaccine GSK1024850A

Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Pneumococcal Vaccine 1024850A When Administered to Children Between 8 Weeks and 2 Years of Age

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 8 Weeks – 23 Months
• Healthy volunteers: Accepted

Summary

The aim of the study is to evaluate the immunogenicity, safety and reactogenicity of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A. Children that are below 6 months at the time of enrolment will also receive the DTPw-HBV/Hib and OPV vaccines.

Detailed description

This protocol posting has been updated according to Protocol Amendment 2, September 2010. The impacted sections are arms and inclusion criteria.

Conditions

• Infections, Streptococcal

Interventions

Type	Name	Description
BIOLOGICAL	GSK1024850A (Synflorix)	2, 3 or 4 intramuscular injection
BIOLOGICAL	Tritanrix-HepB/Hib	Intramuscular injection, 4 doses
BIOLOGICAL	Polio Sabin	4 oral doses

Timeline

• Start date: 2011-06-01
• Primary completion: 2013-01-17
• Completion: 2013-05-23
• First posted: 2010-08-04
• Last updated: 2019-06-06
• Results posted: 2019-06-06

Locations

1 site across 1 country: Burkina Faso