At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 225 enrolled
Drug / intervention
Bexsero® +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.
A Phase 3, Open Label, Randomized, Controlled, Multi-Center Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Meningococcal B Recombinant Vaccine When Administered Concomitantly With Routine Vaccines to Healthy Infants in Taiwan.
In Brief
A Phase 3 clinical trial evaluating Bexsero® and Routine vaccines for Meningococcal Disease and Infections, Meningococcal. Completed, enrolled 225 participants across 2 sites.
Detailed Summary
Assess the safety and immunogenicity of a 3-dose schedule (at 2, 4, 6 months) of GSK Biologicals' Meningococcal B recombinant vaccine followed by a booster at 12 months when concomitantly administered with routine vaccines in healthy infants in Taiwan.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeningococcal Disease, Infections, Meningococcal
CountriesTaiwan
CollaboratorsNovartis Vaccines
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 2014
Enrollment StartSep 2014
Primary CompletionDec 2015
Study CompletionJun 2016
TodayJul 2026
First PostedJun 25, 2014
Enrollment StartSep 11, 2014
Primary CompletionDec 25, 2015
Study CompletionJun 17, 2016
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 12.0 years ago
Interventions
Bexsero®biological
Four doses administered in the anterolateral area of the right or left thigh.
Routine vaccinesbiological
Infanrix-IPV + Hib®, Prevenar-13®, Engerix-B®, Priorix® and Varilrix® administered in the anterolateral area of the right or left thigh.