At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 2,250 enrolled
Drug / intervention
Pneumosil +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, Randomized, Double-Blind Study of the Safety, Tolerability, Lot-to-Lot Consistency, Immunogenicity & Non-Interference With Concomitant Vaccinations of Serum Institute of PNEUMOSIL in Healthy Infants in The Gambia
In Brief
A Phase 3 clinical trial evaluating Pneumosil and Synflorix for Pneumonia, Pneumococcal. Completed, enrolled 2,250 participants across 1 site.
Detailed Summary
This study will examine the consistency of 3 batches of the Pneumosil vaccine by looking at the immune response in infants. In addition, the study will compare the immunogenicity of the Pneumosil vaccine to another WHO-prequalified vaccine, Synflorix.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPneumonia, Pneumococcal
CountriesThe Gambia
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
Enrollment StartJun 2017
First PostedJun 2017
Primary CompletionJun 2018
Study CompletionMay 2019
TodayJul 2026
First PostedJun 23, 2017
Enrollment StartJun 21, 2017
Primary CompletionJun 6, 2018
Study CompletionMay 9, 2019
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 9.0 years ago
Interventions
Pneumosilbiological
10-Valent Pneumococcal Conjugate Vaccine
Synflorixbiological
Pneumococcal conjugate vaccine (Non-Typeable Haemophilus influenzae (NTHi) protein D, diphtheria or tetanus toxoid conjugates) adsorbed