NCT01449812

Immunogenicity and Safety Study of Booster Dose of GSK Biologicals' IPV (Poliorix™) and DTPa/Hib (Infanrix+Hib™) Vaccine

Immunogenicity and Safety of a Booster Dose of GlaxoSmithKline Biologicals' IPV (Poliorix™) and DTPa/Hib (Infanrix+Hib™) in Healthy Chinese Toddlers

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 831 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Months – 24 Months
• Healthy volunteers: Accepted

Summary

The purpose of this booster study is to evaluate the immune persistence in healthy Chinese subjects primed in study NCT01086423 with GSK Biologicals' Infanrix-IPV+Hib™ (DTPa-IPV/Hib) vaccine. The study will also evaluate the safety and immune response of these subjects to a booster dose of Infanrix-Hib™ (DTPa/Hib) and Poliorix™ (IPV) vaccine. This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT01086423).

Conditions

• Acellular Pertussis
• Tetanus
• Diphtheria
• Haemophilus Influenzae Type b

Interventions

Type	Name	Description
BIOLOGICAL	Infanrix+Hib™	Intramuscular, one dose
BIOLOGICAL	Poliorix™	Intramuscular, one dose

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-01-16
• Completion: 2012-01-16
• First posted: 2011-10-10
• Last updated: 2018-06-06
• Results posted: 2017-04-13

Locations

2 sites across 1 country: China