None listed
Conditions
Interventions
Intervention1: HillChol® (BBV131): V. Cholerae (O1 EI Tor Hikojima Serotype recombinant strain) formaldehyde Inactivated Whole Cell administerd as 1.5ml on ay 0 and day 14 by oral
Control Intervention
Sponsors
Bharat Biotech international limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants /Legally acceptable representatives who have the ability to provide written informed consent. 2. Participants of either gender of age . 1 year. 3. Expressed interest and availability to fulfill the study requirements. a. Willing to receive two doses of the vaccine at the specific study site.
Exclusion criteria
Exclusion criteria: 1. Any history of anaphylaxis in relation to vaccination. 2. Participants with Immune function disorders including immunodeficiency diseases, or taking immunosuppressive/cytotoxic agents. 3. An individual is thought to have difficulty participating in the study due to severe chronic diseases, based on the judgment of the investigator. 4. Participants with 38? or higher body temperature measured within 24 hours or at the time of investigational product dosing. 5. Abdominal pain, nausea, vomiting, or decreased appetite within 24 hours before study initiation 6. Diarrhea or administration of anti-diarrheal drugs or antibiotics to treat diarrhea within 1 week before study initiation. 7. Other vaccination within 4 weeks before study initiation. 8. Diarrhea or abdominal pain lasting 2 weeks or longer within 6 months before study initiation. 9. Participation in another clinical trial. 10. History of cholera vaccinations or history of cholera diarrhea. 11. Pregnancy, lactation or willingness/intention to become pregnant during the study. 12. History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ). 13. History of any psychiatric condition likely to affect participation in the study. 14. Suspected or known current alcohol abuse is defined by an alcohol intake of greater than 42 units every week. 15. Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the study or would render the subject unable to comply with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the frequency and severity of all solicited and unsolicited adverse events after administration of two doses of Hillchol® (BBV131) among all three age groups.Timepoint: Day 0 and 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| not applicableTimepoint: not applicable | — |
Countries
India
Contacts
Public ContactDrVKrishna Mohan
Bharat Biotech international limited
Outcome results
None listed