CTRI/2021/09/036179招募中2 期
A Seamless Phase II/III, Observer-blind, Multi-centre, RandomizedClinical Trial to Evaluate Immunogenicity and Safety of BBV87, anInactivated Chikungunya Virus Vaccine in Healthy Subjects 12-65Years of Age - CHIKV 2/3 Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Healthy male and female subjects aged between 12 to 65 years (both inclusive).
- •-Subject or Subjectââ?¬•s Parent should be willing to give voluntary written informed consent and/or assent prior to inclusion in the study.
- •-Must be able to comprehend and comply with study requirements and procedures and be able and willing to complete subject diary.
- •-Willing to consent to the storage and future use of biological samples for CHIKV related research.
- •-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.
排除标准
- •-History of rheumatoid arthritis and moderate or severe arthritis or arthralgia within past 90 days prior to Screening visit.
- •-Subject a known case of diabetes mellitus (Type 1 and 2).
- •-History of degenerative neurological disease (e.g. Guillain Barre Syndrome, Multiple Sclerosis).
- •-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.
- •-History of allergic/hypersensitivity reactions or anaphylaxis to any vaccine or components of study vaccine.
- •-Subject has any acute illness (moderate or severe) at the time of vaccination and/or fever (oral temperature ââ?°Â¥ 38Ã?°C or ââ?°Â¥ 100.4 Ã?°F) within 48 hours prior to vaccination.
- •-Subject has history of cancer, organ transplant, any other clinically significant immunosuppressive condition or autoimmune disease (e.g. Systemic Lupus Erythematosus, autoimmune thyroid disease).
- •-Subject has history of cancer, organ transplant, any other clinically significant immunosuppressive condition or autoimmune disease (e.g. Systemic Lupus Erythematosus, autoimmune thyroid disease).
- •-Subjects who are pregnant or breast feeding.
- •-Prior major surgery or any radiation therapy within 4 weeks of Screening visit.
- •-Positive serologic test for HIV 1 and 2, hepatitis B surface antigen (HBsAg); or any potentially communicable infectious disease as determined by the Investigator.
- •-Current (within 14 days prior to Screening visit) or anticipated concomitant immune-modifying or immunosuppressive therapy (excluding inhaled, topical skin or eye drop-containing corticosteroids, low-dose methotrexate, or corticosteroids at a dose less than 20 mg/day).
- •-Receipt of licensed vaccines within 30 days prior to first vaccination.
- •-Administration of blood, blood products and/or plasma derivatives or any immunoglobulin preparation 90 days prior to screening visit.
- •- 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.
- •-Participating in another clinical trial within 30 days prior to Screening visit or planning to participate during the study
- •-History of participation in Investigational Chikungunya virus vaccine trial.
- •-Any other condition which in the opinion of the Investigator may affect subjectââ?¬•s safety or participation
研究者
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