Trials / Completed
CompletedNCT04760236
Immune Non-Inferiority, Safety and Lot-to-Lot Consistency of Oral Cholera Vaccine-Simplified Compared to Shanchol™
Phase III, Multicenter, Observer-Blinded, Randomized, Active Controlled Trial to Evaluate Immune Non-Inferiority, Safety and Lot-to-Lot Consistency of OCV-S Compared to Shanchol™ in 1 to 40 Years Old Healthy Nepalese Participants
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 2,530 (actual)
- Sponsor
- International Vaccine Institute · Academic / Other
- Sex
- All
- Age
- 1 Year – 40 Years
- Healthy volunteers
- Accepted
Summary
This study is to evaluate immune non-inferiority, safety and lot-to-lot consistency of OCV-S compared to Shanchol™ in 1 to 40 years old healthy Nepalese participants. The investigators hypothesize that the simplified formulation is able to induce non-inferior immunogenicity compared to licensed OCV, Shanchol™.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Oral Cholera Vaccine Simplified (OCV-S) | * Manufacturer: EuBiologics Co., Ltd. * Oral administration |
| BIOLOGICAL | Shanchol™ | * Manufacturer: Shantha Biotechnics * Oral administration |
Timeline
- Start date
- 2021-10-06
- Primary completion
- 2022-12-22
- Completion
- 2023-03-21
- First posted
- 2021-02-18
- Last updated
- 2023-06-22
Locations
4 sites across 1 country: Nepal
Source: ClinicalTrials.gov record NCT04760236. Inclusion in this directory is not an endorsement.