Actively Recruiting
A Seamless Phase II/III, Observer-blind, to Evaluate Immunogenicity and Safety of Chikungunya Virus Vaccine in Healthy Subjects 12-65Years of Age.
Led by Bharat Biotech International Limited · Updated on 2026-04-29
1000
Participants Needed
10
Research Sites
71 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Seamless Phase II/III, Observer-blind, to Evaluate Immunogenicity and Safety of Chikungunya Virus Vaccine in Healthy Subjects 12-65Years of Age.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy males and females aged 12 to 65 years (inclusive)
- Willing to give voluntary written informed consent and/or assent before joining the study
- Able to understand and follow study procedures and complete a subject diary
- Agree to storage and future use of biological samples for Chikungunya virus research
- Sexually active or married males and females of child-bearing potential must agree to use effective birth control for at least 3 months after the last vaccine dose
You will not qualify if you...
- History of rheumatoid arthritis or moderate/severe arthritis or joint pain within 90 days before Visit 1
- Known diagnosis of diabetes mellitus (Type 1 or 2)
- History of degenerative neurological diseases like Guillain Barre Syndrome or Multiple Sclerosis
- Any significant illness, abnormal lab values, or health condition that may affect safety or study results
- History of allergic reactions or anaphylaxis to any vaccine or vaccine components
- Acute illness or fever (temperature 38°C or higher) within 48 hours before vaccination
- History of cancer, organ transplant, immunosuppressive conditions, or autoimmune diseases
- Pregnant or breastfeeding women
- Major surgery or radiation therapy within 4 weeks before Visit 1
- Known or suspected HIV, Hepatitis B infection, or other communicable diseases
- Current or planned immune-modifying or immunosuppressive therapy within 14 days before Visit 1
- Received blood products or immunoglobulins within 90 days before Visit 1
- Active drug or alcohol addiction affecting study adherence
- Participation in another vaccine clinical trial within 30 days before Visit 1
- Any other condition that may affect safety or study participation according to the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
All India Institute of Medical Sciences
Guwahati, Assam, India, 7811101
Not Yet Recruiting
2
All India Institute of Medical Sciences
Patna, Bihar, India, 801507
Not Yet Recruiting
3
All India Institute of Medical Sciences
Raipur, Chhattisgarh, India, 492099
Not Yet Recruiting
4
Redkar Hospital and Research Centre
Mumbai, Goa, India, 403513
Actively Recruiting
5
PGIMS
Rohtak, Haryana, India, 124001
Not Yet Recruiting
6
IMS & SUM Hospital bhubaneshwar Institute of Medical Sciences & SUM Hospital
Bhubaneswar, Odisha, India, 751003
Actively Recruiting
7
Jawahar Lal Nehru medical College
Ajmer, Rajasthan, India, 305001
Not Yet Recruiting
8
Sardar Patel Medical College
Bikaner, Rajasthan, India, 334001
Not Yet Recruiting
9
Guru Teg Bahadur Hospital
Delhi, The National Capital Territory (nct) of Delhi, India, 110029
Actively Recruiting
10
AIIMS Rishikesh Department of Community Medicine
Rishikesh, Uttarakhand, India, 249203
Not Yet Recruiting
Research Team
D
Dr Badri Narayan Patnaik
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
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