A prospective, randomized, two arm, singleblind, parallel, active controlled, multicentre,phase III clinical study to evaluate theimmunogenicity and safety of InactivatedInfluenza vaccine (split virion) I.P.(Tetravalent) of M/s Cadila HealthcareLimited in healthy children aged 6 months to17 years
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 304
- 试验地点
- 4
- 主要终点
- Fulfilment of serologic criteria set by the USFDA for licensure of seasonal
研究概览
简要总结
This is a randomized, single blind, parallel group, multicentre phase III clinical trial to evaluate the immunogenicity and safety of Inactivated Tetravalent Influenza vaccine (split virion) of M/s Cadila Healthcare Limited compared to Vaxigrip (Influenza vaccine (Split Virion, Inactivated) Manufactured by Sanofi Pasteur SA, (France)) in healthy children. Three hundred and four subjects will be randomized to receive either Inactivated Tetravalent Influenza vaccine (split virion) of M/s Cadila Healthcare Limited or Vaxigrip (Influenza vaccine (Split Virion, Inactivated) Manufactured by Sanofi Pasteur SA, (France)) according to the centralized computer generated randomization plan. The enrolled subjects will be divided into three cohorts: Cohort 1 (9 to 17 years), Cohort 2 (3 to 8 years) and Cohort 3 (6 to 35 months). Subjects in Cohort 1 (9 to 17 years) will receive a single dose of Inactivated Influenza vaccine at the baseline visitas per their allocated study group and will be followed up on visit 2 (day 14), visit 3 (day 28, immunogenicity assessment) and visit 4 (day 42, end of study). Subjects in Cohort 2 (3 to 8 years) and Cohort 3 (6 to 35 months) will receive two doses of Inactivated Influenza vaccine at baseline visit and visit 3 (28 days after first vaccination) as per their allocated study group and will be followed on visit 2 (day 14), visit 4 (14 days after second vaccination), visit 5 (28 days after second vaccination,
immunological assessment) and visit 6 (42 days after second vaccination). A pre vaccination and a post vaccination (day 28 after last dose) blood sample will be collected to determine antibody titres attained after vaccination using haemaglutination inhibition assay against the vaccine strains of A/H1N1, A/H3N2, B/Victoria and B/Yamagata. Assessment of vaccine shall be based on the serologic criteria set by the USFDA for licensure of seasonal inactivated Influenza vaccines in pediatric population. The end points for the study are Seroconversion rate, Seroprotection rate and Geometric Mean Titres for all the four viral strains in the two groups, 28 days after last vaccination. The safety of the vaccine will be assessed by recording the adverse events occurring during the entire course of the study
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
- 6.00 Month(s) 至 17.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy subject of either gender 6 months to 17 years of age
- •Written informed consent from subject’s either parent (mother / father) and written assent from subjects more than 7 years of age
- •Subject’s either parent (mother / father) literate 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 vaccine, egg, chicken proteins, aminoglycoside antibiotics
- •Subjects with history of administration of any influenza vaccine 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 ≥ 37.5°C) 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 girls & female subjects of child bearing age 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
Fulfilment of serologic criteria set by the USFDA for licensure of seasonal
时间窗: 28 days after | last vaccination
inactivated Influenza vaccines in pediatric population in Test group
时间窗: 28 days after | last vaccination
次要结局
- Seroprotection rate for all the four viral strains in the two groups, 28 days after(last vaccination)
- Seroconversion rate for all the four viral strains in the two groups, 28 days(after last vaccination)
- Geometric mean titres for all the four viral strains in the two groups, 28 days(after last vaccination)