At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 480 enrolled
Drug / intervention
GSK2202083A vaccine +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.
Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 4 and 12 Months of Age
In Brief
A Phase 2 clinical trial evaluating GSK2202083A vaccine, Prevenar 13®, and 3 other interventions for Tetanus and 6 related conditions. Completed, enrolled 480 participants across 34 sites in 3 countries.
Detailed Summary
This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083 vaccine co-administered with Prevenar 13® at 2, 4 and 12 months of age and with Rotarix™ at 2 and 4 months of age.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTetanus, Hepatitis B, Haemophilus Influenzae Type b, Poliomyelitis, Acellular Pertussis, Diphtheria, Neisseria Meningitidis
CountriesCanada, France, Germany
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2010
Enrollment StartMay 2010
Primary CompletionOct 2011
TodayJul 2026
First PostedMar 22, 2010
Enrollment StartMay 17, 2010
Primary CompletionOct 11, 2011
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 16.3 years ago
Interventions
GSK2202083A vaccinebiological
3 doses given at 2, 4 and 12 months of age
Prevenar 13®biological
3 co-administered doses
Infanrix hexa™biological
3 doses given at 2, 4 and 12 months of age
Menjugate®biological
3 co-administered doses
Rotarix™biological
Oral, two doses