Prevention of Cholera from the use of experimental oral cholera vaccine (Euvichol-Plus)
- Registration Number
- CTRI/2021/08/035344
- Lead Sponsor
- Techinvention lifecare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 416
1.Individuals aged 1 year to 60 years both inclusive
2.Voluntary written informed consent form for study participation provided by an individual or his/her legally acceptable representative. Subjects aged 12 to <18 years, must sign an assent for the study and a parent or a legal guardian have to sign the informed consent. Subject aged 7 to 11 years need to provide an oral consent/assent and the consent form must be signed by parent/legally acceptable representative. Less than 7 years no need of assent, LAR can give consent
3.An individual who can be followed up during the study period and is capable of complying with the study requirements.
4.Healthy subjects as determined by: Medical history, Physical examination and Clinical judgment of the investigator
1.History of cholera vaccinations or history of cholera.
2.History of hypersensitivity reactions to other preventative vaccinations.
3.Immune function disorders including immunodeficiency diseases.
4.38â?? or higher body temperature measured prior to investigational product dosing.
5.Diarrhea or abdominal pain lasting 2 weeks or longer within 6 months prior to study initiation. Also, administration of antidiarrheal drugs or antibiotics to treat diarrhea within 1 week prior to study initiation.
6.Abdominal pain, nausea, vomiting, or decreased appetite within 24 hours prior to study initiation.
7.Pregnant or lactating women should be excluded by performing urine pregnancy test during screening.
8.Children vaccinated within 1 month prior to study initiation or planned vaccination during the study.
9.Participants in another clinical trial with investigational product dosing within 6 months prior to study initiation.
10.An individual thought to have difficulty in participating the study due to severe chronic diseases, based on the judgment of the investigator.
11.An individual thought to have difficulty in participating the study due to other reasons, based on the judgment of the investigator
12.If female patient will get pregnant after first vaccination
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of seroconversion rate :The proportion of subjects with at least 4 times higher anti-V. cholerae O1 Ogawa and Inaba antibody titerTimepoint: 2 Weeks after the second dose (Visit 3) as compared to baseline titers prior to investigational product dosing (Visit 1).
- Secondary Outcome Measures
Name Time Method Assessment of seroconversion rate: The proportion of subjects with at least 4 times higher anti-V. cholerae O139 antibody titerTimepoint: 2 Weeks after the second dose (Visit 3) as compared to baseline titers prior to investigational product dosing (Visit 1);â?¢Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) as measured by anti-V. Cholerae O1 Ogawa and Inaba antibody titerTimepoint: 2 Weeks after the second dose (Visit 3) as compared to baseline titers prior to investigational product dosing (Visit 1).;â?¢Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) as measured by anti-V. Cholerae O139 antibody titerTimepoint: 2 Weeks after the second dose (Visit 3) as compared to baseline titers prior to investigational product dosing (Visit 1).