To Evaluate Safety of Oral Cholera Vaccine Hillchol® (BBV131) (NCT05732766) | Clinical Trial Compass
UnknownPhase 3
To Evaluate Safety of Oral Cholera Vaccine Hillchol® (BBV131)
India1,800 participantsStarted 2023-02-04
Plain-language summary
A Phase III randomized, modified double-blind, multi-centric, comparative study, to evaluate the non-inferiority of immunogenicity and safety of single strain oral cholera vaccine Hillchol® (BBV131) to the comparator vaccine Shanchol™ along with lot-to-lot consistency of Hillchol®(BBV131).
Study Population: A total of 1800 participants will be enrolled in three descending age groups(Group I- ≥18, Group II: ≥5 to \<18 and Group III: ≥1 to \<5). In each group,600 participants will be enrolled and will receive two doses of Hillchol® (BBV131) vaccine two weeks apart.
Who can participate
Age range1 Year – 99 Years
SexALL
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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.
What they're measuring
1
Immediate reaction
Timeframe: Within 30 mins of administration of each dose