To Evaluate Safety of Oral Cholera Vaccine Hillchol® (BBV131)

NCT05732766
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Phase
Phase 3
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Recruitment status
Unknown
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Participants
1,800
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Lead sponsor
Bharat Biotech International Limited
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Start date
2023-02-04
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Number of sites
9
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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.
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Acronym
Hillchol131
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Short title
To Evaluate Safety of Oral Cholera Vaccine Hillchol® (BBV131)
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Official title
A Phase III Randomized, Modified Double-blind, Multi-centric, Comparative Study, to Evaluate Non-inferiority, Immunogenicity and Safety Cholera Vaccine Hillchol® (BBV131) to the Comparator Vaccine Shanchol™ and Hillchol® Lot Consistency
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Unknown
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Phase
Phase 3
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Study type
Interventional
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Completion date
2023-08-01
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First posted
2023-02-17
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Registry last updated
2023-02-17
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Primary completion date
2023-03-01
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Start date
2023-02-04
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Participants
1,800
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Participant count basis
Estimated
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Planned participants
1,800
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Protocol amendments
0
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Number of sites
9
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Bharat Biotech International Limited
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05732766
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ClinicalTrials.gov ID
NCT05732766
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Prevention
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Immediate reaction

    Timeframe: Within 30 mins of administration of each dose

    Adverse reactions after administration of each dose

  2. solicited adverse events

    Timeframe: 7-days

    Incidence, intensity, and the causality of all solicited adverse events during the 7-day follow up period after each dose.

  3. unsolicited adverse events

    Timeframe: 7-days

    Incidence, intensity, and the causality of unsolicited adverse events during the 7-day followup period after each dose.

  4. Serious Adverse Events (SAEs)

    Timeframe: V- :1Baseline (Day 0),V- 2: (Day 14+2),V-3: (Day 28+2),V- 4: (Day 56±7),V-5: (Day 90±7) and V- 6: (Day 180±7)

    Incidence, intensity, and the causality of all adverse events and Serious Adverse Events (SAEs) during the entire study period.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Children, Adults, Older adults
Minimum age
1 Year
Maximum age
99 Years
Healthy volunteers
Yes

  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.

    1. Willing to receive two doses of the vaccine at the specific study site.
    2. Willing to be contacted on the phone to assess adverse events and for study reminders.

  4. Agrees not to participate in another clinical study at any time during the study period.

  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.
Sources for eligibility
clinicaltrials.gov

  • King George Hospital, VisakhapatnamVisakhapatnam, IndiaNot yet recruiting
  • Rajarajeswari Medical College and HospitalKambīpura, IndiaNot yet recruiting
  • All India Institute of Medical Sciences, PatnaPatna, IndiaRecruiting
  • Pt BD Sharma,PGIMS/UHS. RohtakRohtak, IndiaRecruiting
  • Jeevan Rekha Hospital, BelgaumBelagavi, IndiaRecruiting
  • Gillurkar Multispecialty HospitalNagpur, IndiaRecruiting
  • Malla Reddy Narayana Multi Speciality HospitalHyderabad, IndiaNot yet recruiting
  • Rana Hospital Pvt LtdGorakhpur, IndiaRecruiting
  • New Leelamani Hospital Pvt LtdKanpur, IndiaRecruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)