Age-descending Study to Evaluate the Safety and Immunogenicity of the Cholera Conjugate Vaccine in Adults and Children

Recruiting Phase 2 Interventional Study
Cholera Vaccination
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.
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At a Glance
Age
1 – 45
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Prevention
Participants needed
390 (estimated)
Sponsor
International Vaccine Institute · Other
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About This Trial

This phase II study is intended to determine the immunogenicity and safety of single dose and two doses of OSP:rTTHc cholera conjugate vaccine (CCV) with or without alum adjuvant. The study will guide the future dosing schedule and formulation of CCV (with or without Aluminum phosphate adjuvant) expected to be needed in adults and children in cholera-endemic region.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Individuals aged 1 to 45 years at consent 2. Participants/ Participants' legally authorized representative (LAR) willing to provide written informed consent to participate in the study voluntarily 3. Participants who can comply with the study requirements 4. Individuals in go…
Contacts

Naveena D'Cor, MD

+82 2 8811 000

naveena.dcor@ivi.int

CONTACT

Tarun Saluja, MD

+82 2 8811 000

Tarun.Saluja@ivi.int

CONTACT