At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 329 enrolled
Drug / intervention
HIL-214 +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 2, Multi-country, Randomized, Double-blind, Placebo-controlled Trial to Evaluate Safety and Immunogenicity When HIL-214 is Concomitantly Administered With Routine Pediatric Vaccines in Healthy Infants
In Brief
A Phase 3 clinical trial evaluating HIL-214 and Placebo for Gastroenteritis. Completed, enrolled 329 participants across 12 sites in 3 countries.
Detailed Summary
This is a phase 2, multi-country, randomized, double-blind, placebo-controlled trial to evaluate the immune response to routine pediatric vaccinations when co-administered with HIL-214 or placebo in healthy infants. This trial will also evaluate the safety profile of a 2-dose regimen of HIL-214 co-administered with routine pediatric vaccines.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastroenteritis
CountriesPanama, Puerto Rico, United States
Collaborators--
Timeline
Phase 3CompletedFinished
202420252026
First PostedMay 2023
Enrollment StartJun 2023
Primary CompletionJan 2024
Study CompletionJul 2024
TodayJul 2026
First PostedMay 1, 2023
Enrollment StartJun 10, 2023
Primary CompletionJan 19, 2024
Study CompletionJul 8, 2024
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 3.2 years ago
Interventions
HIL-214biological
2 injections - given at 4 months and the second at 6 months of age.
Placebobiological
2 injections - given at 4 months and the second at 6 months of age.