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
- 试验地点
- 10
- 主要终点
- To evaluate the efficacy of Quadrivalent Seasonal Influenza VLP vaccine of Cadila Pharmaceuticals Limited, India based on HI antibody response for at least one of the criteria i.e. seroconversion rate, seroprotection rate and increase in geometric mean HI titer.
研究概览
简要总结
This is a phase-III, prospective, randomized, double-blind, active-controlled, parallel, multicentric, clinical trial to evaluate the immunogenicity and safety of Quadrivalent Seasonal Influenza VLP Vaccine in healthy pediatric and adult population of different age groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 6.00 Month(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy subjects of either gender, with more than 6 month (included) to ≤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, subject’s parent(s) or LAR(s) agrees to comply with protocol requirements and able to sign and date a written, ICF and assent form.
- •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-Barré 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.
- •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.
结局指标
主要结局
To evaluate the efficacy of Quadrivalent Seasonal Influenza VLP vaccine of Cadila Pharmaceuticals Limited, India based on HI antibody response for at least one of the criteria i.e. seroconversion rate, seroprotection rate and increase in geometric mean HI titer.
时间窗: 28 days after last vaccination for all age groups
次要结局
- To evaluate the safety and tolerability of study vaccines.(Solicited AE: 7 days after vaccination for all age groups)
- Comparison of Immunogenicity results between test and reference vaccine for all four vaccine strains(28 days after last vaccination for all age group)
研究者
研究点 (10)
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