At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 905 enrolled
Drug / intervention
nOPV2biological
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 III Open-label Randomized Controlled Study to Evaluate the Safety and Immunogenicity of nOPV2 at Different Intervals of Administration in Infants
In Brief
A Phase 3 clinical trial evaluating nOPV2 for Poliomyelitis. Completed, enrolled 905 participants across 2 sites.
Detailed Summary
Study to determine immunogenicity and safety following administration of 2 doses of novel oral poliovirus vaccine type 2 (nOPV2) given at different intervals of 1 week or 2 weeks or the standard 4-week interval in infants
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPoliomyelitis
CountriesDominican Republic
CollaboratorsBill and Melinda Gates Foundation
Timeline
Phase 3CompletedFinished
20222023202420252026
First PostedSep 2021
Enrollment StartDec 2021
Primary CompletionMay 2022
Study CompletionOct 2022
TodayJul 2026
First PostedSep 5, 2021
Enrollment StartDec 16, 2021
Primary CompletionMay 24, 2022
Study CompletionOct 25, 2022
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 4.8 years ago
Interventions
nOPV2biological
Novel Oral Poliomyelitis Type 2 Vaccine