A Seamless Phase II/III, Observer-blind, to Evaluate Immunogenicity and Safety of Chikungunya Vir… (NCT07555392) | Clinical Trial Compass
RecruitingPhase 2/3
A Seamless Phase II/III, Observer-blind, to Evaluate Immunogenicity and Safety of Chikungunya Virus Vaccine in Healthy Subjects 12-65Years of Age.
India1,000 participantsStarted 2026-04-20
Plain-language 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
Who can participate
Age range12 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria: 1. Healthy male and female subjects aged between 12 to 65 years (both inclusive).
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.
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Exclusion Criteria: 1. History of rheumatoid arthritis and moderate or severe arthritis or arthralgia within past 90 days prior to Visit 1.
2\. Subject a known case of diabetes mellitus (Type 1 and 2). 3. History of degenerative neurological disease (e.g. Guillain Barre Syndrome, Multiple Sclerosis).
4\. Any clinically significant laboratory values or illness or any other current or pre-existing health condition (e.g. any major pulmonary, cardiovascular, renal, neurological, metabolic, gastro-intestinal, hepato-biliary, haematological functional abnormality, mental or physical disability, blood dyscrasia, major congenital defects, etc.) which in the opinion of the Investigator may affect the safety of the subject or the study endpoints.
5\. H…
What they're measuring
1
Geometric mean titres of CHIKV antibodies estimation
Timeframe: 28 days following Dose 2 (Visit 3-DAY 56)
2
Seroconversion percentage
Timeframe: 28 days following Dose 2 (Visit 3-DAY 56)
3
Geometric mean titres of CHIKV antibodies estimation of 3 lots
Timeframe: 28 days following Dose 2 (Visit 3-DAY 56)