Immunogenicity of Two Dosages of Inactivated, Split-Virion Influenza Vaccine Administered by Intradermal Route in Comparison With Intramuscular Vaccination With Vaxigrip® in Adults
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,150
- 试验地点
- 8
- 主要终点
- To provide information concerning the immunogenicity of Inactivated, Split-Virion Influenza Vaccine.
研究概览
简要总结
This is a follow-up of a previous dose-ranging study aimed at investigating 2 doses of the trivalent inactivated split virion influenza vaccine when administered by intradermal route with that of the current pharmaceutical presentation administered by intramuscular route.
Primary Objective:
To assess the immunogenicity of two pharmaceutical presentations of the trivalent inactivated split virion influenza vaccine 21 days after a single injection in subjects aged 18 to 57 years.
Secondary Objective:
To evaluate the safety profile during the 21-day period following each vaccination in each study group
详细描述
This is an open (for the administration route) and double-blind (only for the two dosages administered at year 0 by using the investigational administration route) randomized trial conducted in subjects aged 18 to 60 years. The subjects will receive three vaccine injections at 1-year interval.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 57 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject aged between 18 and 57 years (i.e., less than 60 at the last vaccination)
- •For woman of child-bearing potential, negative urine pregnancy test at V#01
- •Use of effective contraception prior to and during the trial
- •Subject available during the trial period
- •Subject able to read and understand the informed consent form
- •Informed consent form signed and dated by the subject prior to any protocol-required intervention (and Visit 05 and Visit 07, respectively).
排除标准
- •Self-reported allergy to egg proteins, chick proteins, or any of the constituents of the vaccine, in particular, neomycin, formaldehyde, and octoxinol 9
- •Acute febrile disease within the 72 hours preceding V#01, or axillary temperature >37.5°C the day of inclusion, prior to vaccination (>37.0°C Czech Republic)
- •Subject with an aggravation of existing chronic illness (heart disease, respiratory disease, etc.)
- •Vaccination against influenza within the 6 months preceding V#01
- •Any vaccination within the 28 days preceding V#01 or scheduled between V#01 and V#02
- •Breast-feeding
- •Immunosuppressive therapy including long term systemic corticotherapy (20 mg/day of prednisolone or equivalent for >2 weeks) or cancer therapy within the month preceding V#01 or ongoing
- •Immunoglobulin injection within the 3 months preceding V#01
- •Subject taking part or planned to take part in another clinical trial (3 months before and through the trial duration)
- •Subject having received extracted pituitary hormones
- •Subjects who participated in the GID01 study (Lithuanian centers)
研究组 & 干预措施
3
干预措施: Inactivated, split-virion influenza vaccine (Biological)
2
干预措施: Inactivated, split-virion influenza vaccine (Biological)
1
干预措施: Inactivated, split-virion influenza vaccine (Biological)
结局指标
主要结局
To provide information concerning the immunogenicity of Inactivated, Split-Virion Influenza Vaccine.
时间窗: 21days post-vaccination
To provide information concerning the safety of Inactivated, Split-Virion Influenza Vaccine
时间窗: 21 days post-vaccination and entire study duration
次要结局
未报告次要终点