NCT01323647

Immunogenicity and Safety of Booster Dose of PoliorixTM Vaccine in Previously Vaccinated Toddlers

Immunogenicity and Safety of a Booster Dose of GlaxoSmithKline Biologicals' IPV (PoliorixTM) in Healthy Chinese Toddlers

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 957 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Months – 24 Months
• Healthy volunteers: Accepted

Summary

This study aims to evaluate the persistence of anti-poliovirus antibodies in toddlers aged 18 months who were primed with oral polio vaccine (OPV) or inactivated polio vaccine (IPV) in the primary study. The study will also assess the immunogenicity and reactogenicity of a booster dose of IPV in subjects primed with three doses of IPV.

Detailed description

All subjects will also receive a booster dose of GSK Biologicals' DTPa/Hib vaccine (Infanrix+Hib) at Day 0. This vaccine will be provided as part of the local standard of care and will not be associated with any study endpoint.

Conditions

• Poliomyelitis

Interventions

Type	Name	Description
BIOLOGICAL	PoliorixTM	Single dose, intramuscular administration
BIOLOGICAL	Infanrix+Hib	Single dose, intramuscular injection. Part of the local standard of care. No outcome measures associated.

Timeline

• Start date: 2011-04-25
• Primary completion: 2011-09-19
• Completion: 2011-09-19
• First posted: 2011-03-25
• Last updated: 2019-02-11
• Results posted: 2016-12-07

Locations

2 sites across 1 country: China