NCT01106092

Study to Evaluate the Immunogenicity and Reactogenicity of a Booster Dose of GSK2036874A Vaccine in Healthy Toddlers

Immunogenicity and Reactogenicity of a Booster Dose of GlaxoSmithKline Biologicals' GSK2036874A Vaccine in Healthy Toddlers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 312 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 12 Months – 24 Months
• Healthy volunteers: Accepted

Summary

The purpose of the study is to assess the immunogenicity and safety of three formulations of GSK Biologicals' GSK2036874A vaccine compared to Zilbrix™/Hib and Poliorix™ vaccines administered concomitantly, when administered as a single booster dose to healthy poliovirus-primed toddlers aged 12-24 months.

Detailed description

The study will be conducted in a partially double-blinded manner. The study will be double-blinded with respect to the three GSK2036874A formulation groups and open-label with respect to the Control Group.

Conditions

• Haemophilus Influenzae Type b
• Tetanus
• Hepatitis B
• Whole Cell Pertussis
• Diphtheria
• Poliomyelitis Vaccines

Interventions

Type	Name	Description
BIOLOGICAL	GSK2036874A vaccine	Intramuscular, single dose
BIOLOGICAL	Zilbrix™/Hib vaccine	Intramuscular, single dose
BIOLOGICAL	Poliorix™	Intramuscular, single dose

Timeline

• Start date: 2010-05-13
• Primary completion: 2010-09-02
• Completion: 2010-09-02
• First posted: 2010-04-19
• Last updated: 2019-10-01
• Results posted: 2017-04-12

Locations

1 site across 1 country: Philippines