Actively Recruiting
Age-descending Study to Evaluate the Safety and Immunogenicity of the Cholera Conjugate Vaccine in Adults and Children
Led by International Vaccine Institute · Updated on 2026-04-03
390
Participants Needed
1
Research Sites
98 weeks
Total Duration
On this page
Sponsors
I
International Vaccine Institute
Lead Sponsor
E
EuBiologics Co.,Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Age-descending Study to Evaluate the Safety and Immunogenicity of the Cholera Conjugate Vaccine in Adults and Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals aged 1 to 45 years at consent
- Willing to provide written informed consent voluntarily
- Able to comply with study requirements
- In good health based on medical history, physical exam, and investigator judgment
You will not qualify if you...
- Known allergy to vaccine components or other medications
- Major congenital abnormalities
- Known immune disorders including HIV infection
- Use of systemic steroids or immunosuppressive drugs within past 6 months
- Any chronic disease or condition that may compromise safety or study assessment
- Behavioral, cognitive, psychiatric, or neurological disorders interfering with participation
- History of splenectomy
- Known bleeding disorders
- Receipt of blood products or immunoglobulins within past 3 months
- Receipt of other vaccines within 4 weeks before first dose or planned within 4 weeks after last dose
- Active or previous Vibrio cholerae infection
- Severe diarrhea requiring medical care lasting 24+ hours in last 6 months
- Prior cholera vaccine within last 5 years
- Pregnant or lactating females
- Females of childbearing potential not agreeing to effective birth control from 4 weeks before screening to 12 weeks after vaccination
- Participation in another clinical trial within 6 months before or during this study
- Research staff or family members involved in the trial
- Investigator may exclude participants based on medical judgment
- Children under 5 years old with low weight-for-height or height-for-age Z scores less than -2
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
KAVI-Institute of Clinical Research, University
Nairobi, Kenyatta National Hospital Complex, Kenya, 19676
Actively Recruiting
Research Team
N
Naveena D'Cor, MD
CONTACT
T
Tarun Saluja, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
6
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