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

NCT01094171 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2019-03-11

Study results available
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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

BIOLOGICAL

Poliorix TM

Intramuscular administration, 3 doses

BIOLOGICAL

Infanrix TM

Intramuscular administration, 3 doses

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Months
Max Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Russia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01094171 on ClinicalTrials.gov