At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 321 enrolled
Drug / intervention
Infanrix-IPV+Hib™biological
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.
Safety and Reactogenicity of GlaxoSmithKline Biologicals' DTPa-IPV/Hib (Infanrix-IPV+HibTM) in Healthy Vietnamese Toddlers
In Brief
A Phase 3 clinical trial evaluating Infanrix-IPV+Hib™ for Acellular Pertussis and 5 related conditions. Completed, enrolled 321 participants across 1 site.
Detailed Summary
This study aims to evaluate the safety and reactogenicity of a booster dose of Infanrix-IPV+Hib™ when administered to healthy Vietnamese toddlers at 12 to 24 months of age who were vaccinated previously against diphtheria, tetanus, and pertussis diseases within their first six months of lives.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcellular Pertussis, Haemophilus Influenzae Type b, Tetanus, Poliomyelitis, Diphtheria, Diphtheria-Tetanus-aPertussis-Poliomyelitis-Haemophilus Influenzae Type b Vaccines
CountriesVietnam
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 2012
Enrollment StartDec 2012
Primary CompletionApr 2013
TodayJul 2026
First PostedApr 16, 2012
Enrollment StartDec 8, 2012
Primary CompletionApr 9, 2013
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 14.2 years ago
Interventions
Infanrix-IPV+Hib™biological
Single dose administered intramuscularly (IM) into the anterolateral side of the right thigh.