At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 283 enrolled
Drug / intervention
Infanrix™ penta +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 a New Formulation of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine Administered as a Booster Dose to 18-23 Months Old Children
In Brief
A Phase 4 clinical trial evaluating Infanrix™ penta and Infanrix™ hexa for Poliomyelitis and 4 related conditions. Completed, enrolled 283 participants across 3 sites.
Detailed Summary
The new formulation administered as a 4th consecutive dose will be compared to the current formulation of the vaccine in this partially double blind study. The study will be double-blind with respect to the two DTPa-HBV-IPV/Hib groups. The study will be open with respect to the DTPa-HBV-IPV group.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPoliomyelitis, Acellular Pertussis, Tetanus, Diphtheria, Hepatitis B
CountriesRussia
Collaborators--
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 2008
Enrollment StartFeb 2008
Primary CompletionJun 2008
TodayJul 2026
First PostedFeb 11, 2008
Enrollment StartFeb 14, 2008
Primary CompletionJun 25, 2008
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 18.4 years ago
Interventions
Infanrix™ pentabiological
Subjects received a booster dose
Infanrix™ hexabiological
Subjects received a booster dose