To Evaluate Safety of Oral Cholera Vaccine Hillchol® (BBV131) (Hillchol131)
Cholera
About this trial
This is an interventional prevention trial for Cholera
Eligibility Criteria
Inclusion Criteria: Participants /Legally acceptable representatives who have the ability to provide written informed consent. Participants of either gender of age > 1 year. Expressed interest and availability to fulfill the study requirements. Willing to receive two doses of the vaccine at the specific study site. Willing to be contacted on the phone to assess adverse events and for study reminders. Agrees not to participate in another clinical study at any time during the study period. Exclusion Criteria: Any history of anaphylaxis in relation to vaccination. Participants with Immune function disorders including immunodeficiency diseases, or taking immunosuppressive/cytotoxic agents. An individual is thought to have difficulty participating in the study due to severe chronic diseases, based on the judgment of the investigator. Participants with 38℃ or higher body temperature measured within 24 hours or at the time of investigational product dosing. Abdominal pain, nausea, vomiting, or decreased appetite within 24 hours before study initiation Diarrhea or administration of anti-diarrheal drugs or antibiotics to treat diarrhea within 1 week before study initiation. Other vaccination within 4 weeks before study initiation. Diarrhea or abdominal pain lasting 2 weeks or longer within 6 months before study initiation. Participation in another clinical trial. History of cholera vaccinations or history of cholera diarrhea. Pregnancy, lactation or willingness/intention to become pregnant during the study.
Sites / Locations
- King George Hospital, Visakhapatnam
- Rajarajeswari Medical College and Hospital
- All India Institute of Medical Sciences, PatnaRecruiting
- Pt BD Sharma,PGIMS/UHS. RohtakRecruiting
- Jeevan Rekha Hospital, BelgaumRecruiting
- Gillurkar Multispecialty HospitalRecruiting
- Malla Reddy Narayana Multi Speciality Hospital
- Rana Hospital Pvt LtdRecruiting
- New Leelamani Hospital Pvt LtdRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Group-I (Age: ≥18)
Group-II (Age: ≥5 to <18)
Group-III (Age: ≥1 to <5)
Group-I (Age: ≥18) In this group, a total of 600 participants aged ≥18 will be enrolled and administered two doses of Hillchol® (BBV131) on day 0 and 14.
Group-II (Age: ≥5 to <18): In this group, a total of 600 participants aged ≥5 to <18 will be enrolled and administered two doses of Hillchol® (BBV131) on day 0 and 14.
Group-III (Age: ≥1 to <5): In this group, a total of 600 participants aged ≥1 to <5 will be enrolled and administered two doses of Hillchol® (BBV131) on day 0 and 14