An Open-label, Multi-centre, Randomised, Comparative Study of the Immunogenicity and Safety of an Inactivated Split-Virion Influenza Vaccine Administered by Intradermal Route (Flu-ID 15μg) Versus an Inactivated Adjuvanted Influenza Vaccine Administered by Intramuscular Route in Subjects 65 Years of Age or Older
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 795
- 试验地点
- 8
- 主要终点
- Immunogenicity Anti-Haemagglutinin (Anti-HA) antibody titres (1/dil) for the three strains obtained on Day 21 after vaccination.
研究概览
简要总结
Primary objective:
* Immunogenicity To demonstrate that the influenza vaccine administered by intradermal route at least as immunogenic as the adjuvanted influenza vaccine administered by intramuscular route at the same dosage in term of HA antibody titres
Secondary objectives
-
Immunogenicity
-
To describe the immune response 21 days after vaccination with the influenza vaccine administered by ID route versus the adjuvanted influenza vaccine administered by IM route..
-
To describe the compliance of both vaccines administered with the European Medicine Agency (EMEA) Note for Guidance immunogenicity criteria, specific for elderly subjects
-
Safety
- To describe the safety profile after vaccination in each group
-
Acceptability
-
To describe the pain at the injection site
-
To describe the comfort of the injection
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
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 65 years or older on the day of inclusion
排除标准
- •Febrile illness (oral temperature ≥37.5°C) on the day of inclusion
- •Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination
- •Unstable chronic illness
- •Congenital or acquired immunodeficiency,
- •Any blood or blood-derived product in the past 3 months
- •Current abuse of alcohol or drug addiction
- •Any vaccination in the past 4 weeks or planned in the 4 weeks following study vaccination
- •Any vaccination against influenza in the past 6 months
- •Subjects who previously received a vaccination against influenza by intradermal route
研究组 & 干预措施
1
Inactivated Split-Virion Influenza Vaccine for Intradermal Route
干预措施: Flu-ID 15μg (Biological)
2
Inactivated adjuvanted Influenza Vaccine for Intramuscular Route
干预措施: Inactivated adjuvanted Influenza Vaccine (Biological)
结局指标
主要结局
Immunogenicity Anti-Haemagglutinin (Anti-HA) antibody titres (1/dil) for the three strains obtained on Day 21 after vaccination.
时间窗: 21 days
次要结局
- Immunogenicity The derived endpoints will be: - Anti-HA individual titre ratios [Day 21 / Day 0](21 days)
- Occurrence of some solicited adverse reactions occurring from D0 to D3 after vaccination as defined by the EMEA Note for Guidance [CPMP/BWP/214/96](3 days)
- Immunogenicity The derived endpoints will be: - Seroprotection status [anti-HA individual titre ≥40 (1/dil)] on Day 21(21 days)
- Seroconversion or significant increase status at Day 21:anti-HA individual post-vaccination titre ≥40 (1/dil) on D21 for subjects with a pre-vaccination anti-HA individual titre <10 (1/dil) on D0(21 days)
- Seroconversion or significant increase status at D21: ≥4-fold increase from pre- to post-vaccination anti-HA individual titre on D21 for subjects with a pre-vaccination anti-HA individual titre ≥10 (1/dil)(21 days)
- Occurrence, time to onset, number of days of occurrence, and intensity of solicited injection site adverse reactions and systemic adverse reactions occurring from D0 to D7 after vaccination(7 days)
- Occurrence, nature (MedDRA PT), time to onset, duration, intensity, and relationship to vaccination (only for systemic adverse events) of unsolicited (spontaneously reported) adverse events (injection site and systemic) occurring from D0 to visit 2(21 days (plus or minus 3 days))
- Occurrence, nature (MedDRA PT), time to onset, duration, intensity, and relationship to vaccination (only for systemic adverse events) of serious adverse events occurring from D0 to visit 2(21 days (plus or minus 3 days))
- Intensity of pain at the time of injection evaluated just after vaccination on D0 using a Verbal Rating Scale(1 day (day of vaccination))
- Answers to the Vaccination Comfort Questionnaire completed on D21(21 days)