At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 467 enrolled
Drug / intervention
Infanrix™ +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.
Immunogenicity and Reactogenicity Study of GlaxoSmithKline Biologicals' Infanrix™/Hib Vaccine Administered as a Booster Dose to 18-24 Months Old Children
In Brief
A Phase 3 clinical trial evaluating Infanrix™ and Hiberix™ for Acellular Pertussis and 2 related conditions. Completed, enrolled 467 participants across 3 sites.
Detailed Summary
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 = NCT00412854). This Phase IIIB study will compare GSK Biologicals' DTPa/Hib vaccine to separately administered DTPa and Hib vaccines in Chinese children 18 to 24 months of age, in terms of safety and immunogenicity.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcellular Pertussis, Diphtheria, Tetanus
CountriesChina
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2008
First PostedJun 2008
Primary CompletionJul 2008
TodayJul 2026
First PostedJun 12, 2008
Enrollment StartJun 7, 2008
Primary CompletionJul 26, 2008
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 18.1 years ago
Interventions
Infanrix™biological
Intramuscular injection, one dose
Hiberix™biological
Intramuscular injection, one dose