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A Phase III Randomized, Modified Double-blind, Multi-centric, Comparative Study, to Evaluate the Non-inferiority of Immunogenicity and Safety of Hillchol® (BBV131)to Shanchol™ Along With Lot-to-lot Consistency of Hillchol®(BBV131).

NCT05507229 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1800

Last updated 2022-08-18

No results posted yet for this study

Summary

A Phase III randomized, modified double-blind, multi-centric, comparative study, to evaluate the noninferiority 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 3(1350):1(450) ratio. In each group 600 participants will be enrolled and among 600 participants 450 participants will receive any lot of Hillchol® (BBV131) and 150 participants will receive Shanchol™.

DSMB and report:After completion of 7 days post 1st dose for 40 participants (Hillchol (BBV131):10-Lot-I,10-Lot-II,10-Lot-III and 10-shanchol) in the Group I, safety data of these participants will be reviewed by Data Safety Monitoring Board (DSMB) and based on their recommendation, study will progress by recruiting remaining 560 participants in the group I and starting recruitment of participants for group II.

After completion of 7 days post 1st dose for 40 participants (Hillchol (BBV131):10-Lot-I,10-Lot-II,10-Lot-III and 10-shanchol) in the Group II, safety data of these participants will be reviewed by Data Safety Monitoring Board (DSMB) and based on their recommendation, study will progress by recruiting remaining 560 participants in the group II and starting recruitment of participants for group III.

After completion of 7 days post 1st dose for 40 participants (Hillchol (BBV131): 10-Lot-I, 10-Lot-II, 10-Lot-III and 10-shanchol) in the Group III, safety data of these subjects will be reviewed by Data Safety Monitoring Board (DSMB) and based on their recommendation, study will progress by recruiting remaining 560 participants in the group III.

A Final report will be generated, based on the safety and immunogenicity of the oral cholera vaccine (Hillchol®) will be notified to the Data safety monitoring board and Central Drugs Standard Control Organization (CDSCO), India.

Conditions

  • Cholera

Interventions

BIOLOGICAL

Hillchol vaccine

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 strain expressing approximately 50% each of Ogawa and Inaba O1 LPS antigens.

BIOLOGICAL

Shanchol Vaccine

Shanchol™ (Killed Bivalent (O1 and O139) Whole Cell Oral Cholera Vaccine)

Sponsors & Collaborators

  • Bharat Biotech International Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-22
Primary Completion
2022-07-30
Completion
2022-10-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05507229 on ClinicalTrials.gov