CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 957 enrolled
Drug / intervention
PoliorixTM +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.

Search/NCT01323647
NCT01323647Phase 3Completed

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

GlaxoSmithKline·interventional·Posted Mar 25, 2011·Updated Feb 11, 2019

In Brief

A Phase 3 clinical trial evaluating PoliorixTM and Infanrix+Hib for Poliomyelitis. Completed, enrolled 957 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPoliomyelitis
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 25, 2011
Enrollment StartApr 25, 2011
Primary CompletionSep 19, 2011
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 15.3 years ago

Interventions

PoliorixTMbiological

Single dose, intramuscular administration

Infanrix+Hibbiological

Single dose, intramuscular injection. Part of the local standard of care. No outcome measures associated.