None listed
Conditions
Interventions
Intervention1: Euvichol-Plus vaccine: Euvichol-Plus vaccine is a bivalent (O1 and O139) inactivated whole cell Oral Cholera Vaccine (OCV) containing killed whole cells of Vibrio cholerae O1 and Vibrio
Sponsors
Techinvention lifecare Pvt Ltd
Clinical Research Network India CRO
Eligibility
Inclusion criteria
Inclusion criteria: 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 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
India
Contacts
Public ContactDr Nidhi Singh
Clinical Research Network India
Outcome results
None listed