Trials / Completed
CompletedNCT04193215
V114 and Acute Otitis Media (V114-032/PNEU-ERA)
A Study of V114 and Acute Otitis Media in Children (PNEU-ERA)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 7,119 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 42 Days – 90 Days
- Healthy volunteers
- Accepted
Summary
The primary objective is to evaluate V114 in the prevention of vaccine-type acute otitis media (VT-AOM) and the safety of V114 with respect to the proportion of participants with serious adverse events (SAEs) through completion of the study. The primary hypothesis is that V114 is superior to no V114 in preventing VT-AOM as assessed by the incidence of VT-AOM.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | V114 | IM injection |
| OTHER | Pediatric vaccines | Standard of care vaccines administered according to the local recommended schedule. |
Timeline
- Start date
- 2020-09-12
- Primary completion
- 2025-12-22
- Completion
- 2025-12-22
- First posted
- 2019-12-10
- Last updated
- 2026-01-22
Locations
13 sites across 1 country: Thailand
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04193215. Inclusion in this directory is not an endorsement.