BridgeMD
Tests treatment safety and results for Active Immunisation for Chikungunya Virus Infection
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.
ClinicalTrials.gov ID: NCT07555392
What this study is testing
What is BBV87 Chikungunya vaccine?
BBV87 Chikungunya vaccine is an investigational medicine, being studied as a potential treatment for active immunisation for chikungunya virus infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 65
You may be able to join if
- 1. Healthy male and female people 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 people who are sexually active or married and female people who are sexually active or married and are of child-bearing potential should be...
You likely can't join if
- 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...
- 4\. Any clinically significant laboratory values or illness or any other current or pre-existing health condition (e.g. any major pulmonary...
- 5\. History of allergic/hypersensitivity reactions or anaphylaxis to any vaccine or components of study vaccine.
- 6\. Subject has any acute illness (moderate or severe) at the time of vaccination and/or fever (oral temperature ≥ 38°C or ≥ 100.4 °F) within 48...
- 7\. Subject has history of cancer, organ transplant, any other clinically significant immunosuppressive condition or autoimmune disease (e.g...
See the full eligibility criteria
- 1. Healthy male and female people 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 people who are sexually active or married and female people 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...
- 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...
- 5\. History of allergic/hypersensitivity reactions or anaphylaxis to any vaccine or components of study vaccine.
- 6\. Subject has any acute illness (moderate or severe) at the time of vaccination and/or fever (oral temperature ≥ 38°C or ≥ 100.4 °F) within 48 hours prior to vaccination.
- 7\. Subject has history of cancer, organ transplant, any other clinically significant immunosuppressive condition or autoimmune disease (e.g. Systemic Lupus Erythematosus, autoimmune thyroid disease). 8. people who are...
- 11\. Current (within 14 days before Visit 1) or anticipated concomitant immune-modifying or immunosuppressive therapy (excluding inhaled, topical skin, or eye drop-containing corticosteroids, low-dose methotrexate, or...
- 12\. Administration of blood or blood product derivatives or any immunoglobulin preparation, 90 days before Visit 1.
- 13\. Active addictive drug or alcohol use or dependence that, in the opinion of the Investigator, would interfere with adherence to study requirements or assessment of immunologic endpoints.
- 14\. Participating in a clinical trial of any vaccine, including CHIKV, within 30 days before Visit 1 or planning to participate during the study.
- 15\. Any other condition which in the opinion of the Investigator may affect subject's safety or participation.
The study team makes the final eligibility decision.
Where it's taking place
- Guwahati, Assam, India
- Patna, Bihar, India
- Raipur, Chhattisgarh, India
- Mumbai, Goa, India
- Rohtak, Haryana, India
- Bhubaneswar, Odisha, India
- Ajmer, Rajasthan, India
- Bikaner, Rajasthan, India
- Delhi, The National Capital Territory (nct) of Delhi, India
- Rishikesh, Uttarakhand, India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guwahati, Assam, India; Patna, Bihar, India; Raipur, Chhattisgarh, India; Mumbai, Goa, India; Rohtak, Haryana, India; Bhubaneswar, Odisha, India and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.