At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 421 enrolled
Drug / intervention
GSK2202083A vaccine +3 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 Safety Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 3 and 4 Months of Age
In Brief
A Phase 2 clinical trial evaluating GSK2202083A vaccine, 10-valent pneumococcal vaccine (GSK 1024850A), and 2 other interventions for Tetanus and 6 related conditions. Completed, enrolled 421 participants across 9 sites.
Detailed Summary
This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine co-administered with GSK Biologicals' 10-valent pneumococcal conjugate (GSK1024850A) vaccine given as a three-dose primary vaccination course at 2, 3 and 4 months of age.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTetanus, Diphtheria, Haemophilus Influenzae Type b, Poliomyelitis, Acellular Pertussis, Hepatitis B, Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b-Neisseria Meni
CountriesPoland
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2009
First PostedSep 2009
Primary CompletionJan 2010
TodayJul 2026
First PostedSep 2, 2009
Enrollment StartAug 13, 2009
Primary CompletionJan 27, 2010
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 16.8 years ago
Interventions
GSK2202083A vaccinebiological
Intramuscular, three doses
10-valent pneumococcal vaccine (GSK 1024850A)biological
Intramuscular, three doses
Infanrix hexa™biological
Intramuscular, three doses
Menjugate®biological
Intramuscular, two doses