CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 454 enrolled
Drug / intervention
Infanrix™-IPV+Hib +4 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/NCT01309646
NCT01309646Phase 3Completed
CompareCT.gov

Immunogenicity and Safety of GlaxoSmithKline Biologicals' DTPa-IPV/Hib (Infanrix™-IPV+Hib) Vaccine in Healthy Korean Infants

GlaxoSmithKline·interventional·Posted Mar 7, 2011·Updated Nov 27, 2019

In Brief

A Phase 3 clinical trial evaluating Infanrix™-IPV+Hib, Infanrix™ IPV, and 3 other interventions for Poliomyelitis and 4 related conditions. Completed, enrolled 454 participants across 11 sites.

Detailed Summary

This study is designed to evaluate the safety and immunogenicity of Infanrix™-IPV+Hib vaccine when administered as a primary vaccination course to healthy Korean infants at 2, 4 and 6 months of age.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPoliomyelitis, Tetanus, Acellular Pertussis, Diphtheria, Haemophilus Influenzae Type b
CountriesSouth Korea
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 7, 2011
Enrollment StartMar 4, 2011
Primary CompletionFeb 24, 2012
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 15.3 years ago

Interventions

Infanrix™-IPV+Hibbiological

Intramuscular, 3 doses

Infanrix™ IPVbiological

Intramuscular, 3 doses

Hiberix™biological

Intramuscular, 3 doses

Synflorix™biological

Intramuscular, 3 doses

Rotarix™biological

Oral, 2 doses