CTRI/2021/11/038282已完成3 期
A phase-III, randomized, double-blind, active-controlled, multi-center, clinical trial to evaluate the immunogenicity and safety of Quadrivalent seasonal influenza virus-like particle (VLP) vaccine of Cadila Pharmaceuticals Limited, India, in healthy human population.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 660
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
- •1.Healthy subjects of either gender, with more than 6 month (included) to ââ?°Â¤65 years of age with no prior history of influenza vaccination.
- •2.Subjects who are in good health at the time of randomization into the study.
- •3.For subjects aged 6 to 35 months only: born at full term of pregnancy ( >37
- •weeks) or birth weight >2.5 kg or both.
- •4.Subject, subjectââ?¬•s parent(s) or LAR(s) agrees to comply with protocol requirements and able to sign and date a written, ICF and assent form.
- •5.Documented negative test for human immunodeficiency virus (HIV-1/2),HBsAg or HCV.
- •6.Female subject with negative Urine pregnancy test.
排除标准
- •1.Any condition determined likely to interfere with evaluation of the vaccine or having potential health risk to the subject or make it unlikely that the subject would complete the study.
- •2.Subjects with history of administration of any influenza vaccine or subjects with laboratory confirmed influenza in past one year.
- •3.Screening serum transaminase or alkaline phosphatase, creatinine and total bilirubin >1.5 times of ULN.
- •4.History of hypersensitivity to any component of the vaccines.
- •5.Any known immunocompromising condition or immunosuppressive therapy within 6 months preceding enrolment.
- •6.History of any use of systemic glucocorticoids and influenza antiviral medication.
- •7.History of underlying medical conditions, seizures or any progressive neurological disease, any congenital abnormalities, including hemoglobinopathies.
- •8.Children and adolescents receiving aspirin- or salicylate-containing medications and who might be at risk for experiencing Reye syndrome after influenza virus infection.
- •9.History of multiple sclerosis, lupus, Guillain-BarrÃ?© syndrome, thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy.
- •10.Immunocompromised subjects
- •11.Subjects administered blood, blood containing products or Immunoglobulins within the last 3 months or planned administration during the study.
- •12.Any other vaccine administration within the last 30 days or planned to be administered during the study period.
- •13.Documented fever of > 100.4 Ã?°F or above as axillary temperature in the preceding 14 days before screening.
- •14.Pregnant and lactating girls and female subjects of child bearing age not using acceptable contraceptive measures.
- •15.Participation in another clinical trial during past 3 month prior to screening
研究者
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