None listed
Conditions
Interventions
Intervention1: HillChol®(BBV131): (Whole cell inactivated Stable Hikojima expressing both
Inaba and Ogawa LPS) inactivated bacteria of a stable recombinant Vibrio
cholerae O1 El Tor Hikojima serotype
Sponsors
Bharat Biotech International Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Participants/Legally Acceptable representatives who have ability to provide written informed consent. 2.Ability to provide written informed consent (by the parents or legally acceptable/authorized representative (LAR) and assent by the children (verbal/oral assent for the children of age between 1-12 years, and written assent for the children of age between >12 to 18 years). 3.Participants of either gender of age > 1 year. 4.Expressed interest and availability to fulfil the study requirements. a.Willing to receive two doses of the vaccine at the specific study site. b.Willing to be contacted on the phone to assess adverse events and for study reminders. 5.Agrees not to participate in another clinical study at any time during the study period.
Exclusion criteria
Exclusion criteria: 1.Any history of anaphylaxis in relation to vaccination. 2.Participant with Immune function disorders including immunodeficiency diseases, or taking immunosuppressive/cytotoxic agents. 3.An individual 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 prior to study initiation. 6.Diarrhea or administration of anti-diarrheal drugs or antibiotics to treat diarrhea within 1 week prior to study initiation. 7.Other vaccination within 4week prior to study initiation. 8.Diarrhea or abdominal pain lasting 2 weeks or longer within 6 months prior to study initiation. 9.Participation in another clinical trial 10.History of Cholera vaccinations or history of confirmed cholera infection 11.Pregnancy, lactation or willingness/intention to become pregnant during the study. 12.Immunoglobulin within 3 months prior to study vaccination, during and 21 days following the last dose of study vaccination 13.Anti-cytokine anti-bodies within 3 months prior to study vaccination, during and 21 days following the last dose of study vaccination. 14.Any kind of blood products within 3 months prior to study vaccination and 21 days following the last dose of study vaccination. 15. Immunosuppressants and immune modifying agents within 6 months prior to study vaccination and 21 days following the last dose of study vaccination. 16.History of cancer 17.History of any psychiatric condition likely to affect participation in the study 18.Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of participants achieving seroconversion against 1.Ogawa serotype 2.Inaba serotypeTimepoint: 1) 14 days after 2 doses of test or comparator vaccine. 2) 14 days after 2 doses of test or comparator vaccine. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Geometric Mean Titers (GMT) of anti-Ogawa antibodies 2.GMT of anti-Inaba antibodies 3.Immediate reaction: Within 30 mins of administration of each dose. 4.Incidence, intensity, the causality of all solicited adverse events. 5.Incidence, intensity, the causality of unsolicited adverse events. 6.Incidence, intensity, the causality of all adverse events and Serious Adverse Events (SAEs)Timepoint: 1) Two weeks after 2 doses of Test or comparator vaccine. 2)Two weeks after 2 doses of Test or comparator vaccine. 3)7-day follow-up period after each dose. 4)14-day follow-up period after each dose. | — |
Countries
India
Contacts
Public ContactDr V Krishna Mohan
Bharat Biotech International Limited
Outcome results
None listed