A prospective, randomized, two arm, single blind, parallel, active controlled, multicentre, phase II/III clinical study to evaluate the immunogenicity and safety of Inactivated Tetravalent Influenza vaccine (split virion) of M/s Cadila Healthcare Limited compared to marketed Inactivated Trivalent Influenza vaccine in healthy adults
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 入组人数
- 348
- 试验地点
- 7
- 主要终点
- 1.Serologic parameters set by the Committee for Medicinal Products for Human Use (CHMP) for influenza vaccines
研究概览
简要总结
This is a randomized, single blind, parallel group,multicentre, non-inferiority phase II/III clinical trial to evaluate theimmunogenicity and safety of Inactivated Tetravalent Influenza vaccine (splitvirion) of M/s Cadila Healthcare Limited compared to Vaxigrip (Influenzavaccine (Split Virion, Inactivated) Manufactured by Sanofi Pasteur SA, (France))in healthy adults. Three hundred and forty eight subjects will be randomized toreceive either Inactivated Tetravalent Influenza vaccine (split virion) of M/sCadila Healthcare Limited or Vaxigrip (Influenza vaccine (Split Virion,Inactivated) Manufactured by Sanofi Pasteur SA, (France)) according to thecentralized computer generated randomization plan. A pre vaccination and a postvaccination (day 21) blood sample will be collected to determine antibodytitres attained after vaccination using haemaglutination inhibition assay againstthe vaccine strains of A/H1N1, A/H3N2, B/Victoria and B/Yamagata. Assessment ofvaccine shall be based on the serologic parameters set by the Committee forMedicinal Products for Human Use (CHMP) for influenza vaccines. The end pointsfor the study are Seroconversion rate, Seroprotection rate and Geometric Mean Titresfor all the four viral strains in the two groups at the end of study. Theresults will also be stratified by age groups (adults: ≥18 to 60 years; andelderly: >60 years). The safety of the vaccine will be assessed by recordingthe adverse events occurring during the entire course of the study (42 days)
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy subject of either gender ≥ 18 years of age
- •Written informed consent from subjects
- •Adult subjects literature enough to fill the diary card.
排除标准
- •Past history of hypersensitivity reaction, neurological disorder (Guillain–Barré syndrome or others) or any serious adverse event to any component of influenza vaccine, egg, chicken proteins, aminoglycoside antibiotics
- •Subjects with history of administration of any influenza vaccine within the past 6 months or subjects with laboratory confirmed influenza in past
- •Subjects with thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy
- •Subjects with confirmed or suspected immunosuppressive or immunodeficiency disorder; or subjects on any immunosuppressive or immunostimulant therapy
- •Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, hematological or immunological disorder
- •Subjects with febrile illness (temperature ≥ 100.4°F) at the time of enrolment, or acute respiratory pathology or infections requiring systemic antibiotic or antiviral therapy during the preceding 7 days
- •Subjects administered blood, blood containing products or immunoglobulins within the last 3 months or planned administration during the study
- •Any other vaccine administration within the last 30 days or planned to be administered during the study period
- •Pregnant and lactating women & female subjects not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization)
- •Participation in another clinical trial in the past 3 months.
结局指标
主要结局
1.Serologic parameters set by the Committee for Medicinal Products for Human Use (CHMP) for influenza vaccines
时间窗: 21 days following vaccination
2. Seroconversion rate for all the four viral strains in the two groups at the end of study
时间窗: 21 days following vaccination
次要结局
- Geometric mean titres for all the four viral strains in the two groups at the end of the study(21 days following vaccination)
- Seroprotection rate for all the four viral strains in the two groups at the end of the study(21 days following vaccination)
- Local and systemic adverse events reported during the study(42 days following vaccination)