NCT01094171

Study to Evaluate the Safety of Co-administration of GSK Biologicals' Poliorix and Infanrix in Healthy Children in Russia

A Phase IV (Not Interventional), Open-label, Multicentre Study to Evaluate the Reactogenicity and Safety of Co-administration of GlaxoSmithKline Biologicals' DTPa (Infanrix) and IPV (Poliorix) Vaccines Administered as Three-dose Primary Immunisation Course at 3, 4.5 and 6 Months of Age in Healthy Children in Russian Federation

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 3 Months – 6 Months
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess reactogenicity and safety of simultaneous administration of GSK Biologicals' inactivated poliomyelitis vaccine Poliorix and GSK Biologicals' DTPa-vaccine Infanrix vaccines in healthy children in Russian Federation in their first year of life according to National Calendar of Prophylactic Immunisation of Russian Federation.

Conditions

• Poliomyelitis

Interventions

Type	Name	Description
BIOLOGICAL	Poliorix TM	Intramuscular administration, 3 doses
BIOLOGICAL	Infanrix TM	Intramuscular administration, 3 doses

Timeline

• Start date: 2010-12-03
• Primary completion: 2012-10-27
• Completion: 2012-10-27
• First posted: 2010-03-26
• Last updated: 2019-03-11
• Results posted: 2013-12-30

Locations

2 sites across 1 country: Russia