Trial to Evaluate Immunogenicity Non-Inferiority, Safety and Lot-to-Lot Consistency of Biovac OCV-S to Euvichol®-Plus
Recruiting
Phase 3
Interventional Study
Cholera Vaccination
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 1 – 45
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 2,824 (estimated)
- Sponsor
- International Vaccine Institute · Other
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
This Phase I/III clinical trial is intended to establish the immunogenicity and safety profile of Biovac OCV-S compared to available WHO pre-qualified vaccine Euvichol®-Plus in healthy adults and children and in adult people living with HIV (PLWH). The lot-to-lot consistency of Biovac OCV-S in healthy adults will also be determined.
Trial Locations
Loading…
Loading trial locations…
Eligibility Criteria
Inclusion Criteria:
Inclusion Criteria (for healthy/HIV-negative cohorts A, B and C)
1. Healthy participants aged 1 to 45 years at consent
2. Participants/Parent(s)/Legally Authorized Representative (LAR) willing to provide informed consent/assent
3. HIV negative
4. Not pregnant or lactating
Incl…
Contacts
Dr. Naveena D'Cor Project Technical Lead / Study Medical Monitor, MD
+82 2 8811 000
CONTACT