NCT01204658

Safety & Immunogenicity of Pneumococcal Vaccine 2189242A Co-administered With DTPa-HBV-IPV/Hib in Healthy Infants

Safety, Reactogenicity & Immunogenicity of GSK Biologicals' Pneumococcal Vaccine 2189242A When Co-administered With DTPa-HBV-IPV/Hib Vaccine in Healthy Infants

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 576 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 6 Weeks – 14 Weeks
• Healthy volunteers: Accepted

Summary

This study will assess the safety, reactogenicity and immunogenicity of two formulations of GSK Biologicals' pneumococcal vaccine 2189242A given as a 3-dose primary vaccination course during the first 6 months of life followed by a booster dose at 12-15 months of age and co-administered with DTPa-HBV-IPV/Hib vaccine.

Detailed description

This study will assess the safety, reactogenicity, immunogenicity and persistence of two formulations of GSK Biologicals' pneumococcal vaccine 2189242A \[high dose (HD) or low dose (LD)\] given as a 3-dose primary vaccination course during the first 6 months of life followed by a booster dose at 12-15 months of age when co-administered with Infanrix hexa™ and compared to the vaccination with Synflorix™ and with Prevnar 13™ similarly co-administered with the Infanrix hexa™ vaccine.

Conditions

• Infections, Streptococcal

Interventions

Type	Name	Description
BIOLOGICAL	Pneumococcal vaccine GSK 2189242A (LD formulation 1)	Intramuscular injection
BIOLOGICAL	Pneumococcal vaccine GSK 2189242A (HD formulation 2)	Intramuscular injection
BIOLOGICAL	Synflorix	Intramuscular injection
BIOLOGICAL	Prevenar 13	Intramuscular injection
BIOLOGICAL	Infanrix Hexa (DTPa-HBV-IPV/Hib)	Intramuscular injection

Timeline

• Start date: 2010-09-27
• Primary completion: 2011-11-03
• Completion: 2012-10-01
• First posted: 2010-09-17
• Last updated: 2019-05-29
• Results posted: 2016-09-28

Locations

24 sites across 4 countries: Czechia, Germany, Poland, Sweden