CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 831 enrolled
Drug / intervention
Infanrix+Hib™ +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/NCT01449812
NCT01449812Phase 3Completed
CompareCT.gov

Immunogenicity and Safety of a Booster Dose of GlaxoSmithKline Biologicals' IPV (Poliorix™) and DTPa/Hib (Infanrix+Hib™) in Healthy Chinese Toddlers

GlaxoSmithKline·interventional·Posted Oct 10, 2011·Updated Jun 6, 2018

In Brief

A Phase 3 clinical trial evaluating Infanrix+Hib™ and Poliorix™ for Acellular Pertussis and 3 related conditions. Completed, enrolled 831 participants across 2 sites.

Detailed Summary

The purpose of this booster study is to evaluate the immune persistence in healthy Chinese subjects primed in study NCT01086423 with GSK Biologicals' Infanrix-IPV+Hib™ (DTPa-IPV/Hib) vaccine. The study will also evaluate the safety and immune response of these subjects to a booster dose of Infanrix-Hib™ (DTPa/Hib) and Poliorix™ (IPV) vaccine. This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT01086423).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcellular Pertussis, Tetanus, Diphtheria, Haemophilus Influenzae Type b
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 10, 2011
Enrollment StartOct 1, 2011
Primary CompletionJan 16, 2012
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 14.7 years ago

Interventions

Infanrix+Hib™biological

Intramuscular, one dose

Poliorix™biological

Intramuscular, one dose