drugset / Trial / NCT01094171

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

NCT01094171

Phase 4 Completed 400 enrolled GlaxoSmithKline
NaSingle-groupOpen-labelPrevention

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.

Timeline

Start
2010-12-03
Primary completion
2012-10-27
Completion
2012-10-27

Publications

  • Background Romanenko VV et al. (2016) Safety and reactogenicity of inactivated vaccine for polio prevention (Poliorix ™) output and DTP vaccine (Infanrix ™) in a joint application for trehdozovoy scheme in healthy children in Russia. Ural Med Jq. 9(142):138-144.

Drugs

EvaluationDrugModalityDoseRoute
Subject Adacel Vaccine Intramuscular
Subject Poliorix™ Vaccine Intramuscular

Indications