A Seamless Phase II/III, Observer-blind, Multi-centre, Randomized Clinical Trial to Evaluate Immunogenicity and Safety of BBV87, an Inactivated Chikungunya Virus Vaccine in Healthy Subjects 12-65 Years of Age.
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
A Seamless Phase II/III, Observer-blind, Multi-centre, Randomized Clinical Trial to Evaluate Immunogenicity and Safety of BBV87, an Inactivated Chikungunya Virus Vaccine in Healthy Subjects 12-65 Years of Age
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 65
Healthy Volunteers: f
View:
• 2\. Subject or Subject's Parent should be willing to give voluntary written informed consent and/or assent prior to inclusion in the study.
• 3\. Must be able to comprehend and comply with study requirements and procedures and be able and willing to complete subject diary.
• 4\. Willing to consent to the storage and future use of biological samples for CHIKV related research.
• 5\. Male subjects who are sexually active or married and female subjects who are sexually active or married and are of child-bearing potential should be willing to follow effective birth control\* methods for at least 3 months after the last dose of vaccine.
• \-
Locations
Other Locations
India
Jawahar Lal Nehru medical College
NOT_YET_RECRUITING
Ajmer
IMS & SUM Hospital bhubaneshwar Institute of Medical Sciences & SUM Hospital
RECRUITING
Bhubaneswar
Sardar Patel Medical College
NOT_YET_RECRUITING
Bikaner
Guru Teg Bahadur Hospital
RECRUITING
Delhi
All India Institute of Medical Sciences
NOT_YET_RECRUITING
Guwahati
Redkar Hospital and Research Centre
RECRUITING
Mumbai
All India Institute of Medical Sciences
NOT_YET_RECRUITING
Patna
All India Institute of Medical Sciences
NOT_YET_RECRUITING
Raipur
AIIMS Rishikesh Department of Community Medicine
NOT_YET_RECRUITING
Rishikesh
PGIMS
NOT_YET_RECRUITING
Rohtak
Contact Information
Primary
Dr Badri Narayan Patnaik
badri5633@bharatbiotech.com
914023480567
Time Frame
Start Date:2026-04-20
Estimated Completion Date:2027-08-30
Participants
Target number of participants:1000
Treatments
Experimental: Group A- Chikungunya vaccine
BBV87 Chikungunya vaccine LOT 1- Dose 1 is administered intramuscularly in the deltoid region of the arm. Dose 2 of the study vaccine will be administered at Visit 2 (28+5 days following Dose 1).
Experimental: Group B-Chikungunya vaccine
BBV87 Chikungunya vaccine LOT 2- Dose 1 is administered intramuscularly in the deltoid region of the arm. Dose 2 of the study vaccine will be administered at Visit 2 (28+5 days following Dose 1).
Experimental: Group C-Chikungunya vaccine
BBV87 Chikungunya vaccine LOT 3- Dose 1 is administered intramuscularly in the deltoid region of the arm. Dose 2 of the study vaccine will be administered at Visit 2 (28+5 days following Dose 1).
Placebo_comparator: Group D-Placebo
Placebo - Dose 1 is administered intramuscularly in the deltoid region of the arm. Dose 2 will be administered at Visit 2 (28+5 days following Dose 1).