At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 400 enrolled
Drug / intervention
Poliorix TM +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating Poliorix TM and Infanrix TM for Poliomyelitis. Completed, enrolled 400 participants across 2 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPoliomyelitis
CountriesRussia
Collaborators--
Timeline
Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2010
Enrollment StartDec 2010
Primary CompletionOct 2012
TodayJul 2026
First PostedMar 26, 2010
Enrollment StartDec 3, 2010
Primary CompletionOct 27, 2012
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 16.3 years ago
Interventions
Poliorix TMbiological
Intramuscular administration, 3 doses
Infanrix TMbiological
Intramuscular administration, 3 doses