NCT01616459

Immunogenicity and Safety of Two Formulations of GSK Biologicals' Pneumococcal Vaccine (2830929A and 2830930A) When Administered in Healthy Infants

Immunogenicity and Safety Study of Two Formulations of GlaxoSmithKline (GSK) Biologicals' Pneumococcal Vaccine (2830929A and 2830930A) When Administered in Healthy Infants

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 953 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 6 Weeks – 12 Weeks
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the immunogenicity, reactogenicity and safety of two formulations of GSK Biologicals' pneumococcal vaccine (2830929A and 2830930A) administered as 3-dose primary vaccination during the first 6 months of life followed by a booster dose in the second year of life. To comply with the routine infant immunisation program, the licensed GSK Biologicals DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine will be co-administered in infants with the pneumococcal study vaccines.

Detailed description

The purpose of this study is to assess the immunogenicity of the two formulations of GSK Biologicals' pneumococcal vaccine 2830929A (11-valent vaccine or 11Pn vaccine) and 2830930A (12-valent vaccine or 12Pn vaccine), when administered as 3-dose primary vaccination during the first 6 months of life followed by a booster dose in the second year of life, when compared to immune responses to the licensed vaccines Synflorix™ and Prevnar 13™, and to assess the reactogenicity and safety of these two same investigational formulations when administered according to this schedule. To comply with the routine infant immunisation program, the licensed GSK Biologicals DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine will be co-administered in infants with the pneumococcal study vaccines.

Conditions

• Infections, Streptococcal

Interventions

Type	Name	Description
BIOLOGICAL	Pneumococcal conjugate vaccine GSK2830929A	Intramuscular injection
BIOLOGICAL	Pneumococcal conjugate vaccine GSK2830930A	Intramuscular injection
BIOLOGICAL	Synflorix™	Intramuscular injection
BIOLOGICAL	Prevnar 13™	Intramuscular injection
BIOLOGICAL	Infanrix hexa™	Intramuscular injection

Timeline

• Start date: 2012-07-11
• Primary completion: 2013-04-25
• Completion: 2014-01-22
• First posted: 2012-06-11
• Last updated: 2019-07-16
• Results posted: 2014-06-16

Locations

42 sites across 4 countries: Czechia, Germany, Poland, Spain