CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 985 enrolled
Drug / intervention
Infanrix-IPV/Hib™ +2 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/NCT01086423
NCT01086423Phase 3Completed
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Immunogenicity and Safety of GlaxoSmithKline Biologicals' DTPa-IPV/Hib (Infanrix-IPV+Hib™) in Infants

GlaxoSmithKline·interventional·Posted Mar 15, 2010·Updated Jun 6, 2018

In Brief

A Phase 3 clinical trial evaluating Infanrix-IPV/Hib™, Infanrix Hib™, and 1 other intervention for Tetanus and 4 related conditions. Completed, enrolled 985 participants across 2 sites.

Detailed Summary

The purpose of the study is to evaluate the immunogenicity and reactogenicity of Infanrix-IPV/Hib™ vaccine when administered to healthy Chinese infants at 2, 3 and 4 or 3, 4 and 5 months of age.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTetanus, Poliomyelitis, Acellular Pertussis, Diphtheria, Haemophilus Influenzae Type b
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 15, 2010
Enrollment StartMar 1, 2010
Primary CompletionNov 19, 2010
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 16.3 years ago

Interventions

Infanrix-IPV/Hib™biological

Intramuscular, three doses

Infanrix Hib™biological

Intramuscular, three doses

Poliorix™biological

Intramuscular, three doses