An Open-label, Randomised, Multicentre Study to Evaluate the Immunogenicity and Safety of a Booster Dose of Diphtheria, Tetanus, Acellular Pertussis and Inactivated Poliomyelitis Adsorbed Vaccine (REPEVAX) Administered Concomitantly Versus Non-concomitantly With an Influenza Vaccine (VAXIGRIP) to Subjects of 60 Years of Age and Older
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 954
- 试验地点
- 20
- 主要终点
- Flu geometric mean of titres ratio
研究概览
简要总结
Primary objectives:
To demonstrate that REPEVAX and VAXIGRIP administered concomitantly in subjects 60 years of age and older are at least as immunogenic as REPEVAX or VAXIGRIP administered separately.
Secondary objectives:
•Secondary immunogenicity objectives: To describe the immune responses 28 days after concomitant or separate administration of REPEVAX and VAXIGRIP in subjects 60 years of age and older To describe the immune response of VAXIGRIP according to European Medicines Agency criteria in subjects 60 years of age and older (Note for Guidance, 1997: 28)
•Secondary safety objective: To describe the safety profile after vaccination in each group
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
- 60 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged ≥60 years
- •At least one documented booster dose with a tetanus- and diphtheria-containing vaccine between 5 and 15 years
- •No influenza vaccine administered during the last 6 months
排除标准
- •Receipt of a booster dose with a tetanus or diphtheria- or poliomyelitis- containing vaccine within the last 5 years
- •Receipt of pertussis-containing vaccine or pertussis disease within the last 10 years
- •Receipt of medication / vaccine that may interfere with study assessments
- •Febrile illness or moderate or severe acute illness/infection
- •History of hypersensitivity or anaphylactic or other allergic reactions to any of the vaccine components, or history of a life-threatening reaction to the study vaccines or a vaccine containing any of the same substances
- •History of Guillain Barré syndrome or brachial neuritis following a previous vaccination
- •History of encephalopathy of unknown origin within 7 days after immunization with a pertussis-containing vaccine or unstable neurological disorders
- •Known or suspected immune dysfunction
- •Thrombocytopenia, bleeding disorder or anticoagulants contraindicating intramuscular vaccination
- •Chronic disease that is unstable or any intercurrent illness that might interfere with the ability to participate fully in the study; or interfere with evaluation of the vaccine
研究组 & 干预措施
1- VAXIGRIP and REPEVAX concomitantly
干预措施: Concomitant administration (Biological)
2-REPEVAX 28 days after VAXIGRIP
干预措施: Separate administration (Biological)
结局指标
主要结局
Flu geometric mean of titres ratio
时间窗: 28 to 35 days after vaccine administration
Pertussis antibody titre
时间窗: 28 to 35 days after vaccine administration
Diphtheria seroprotection rate
时间窗: 28 to 35 days after vaccine administration
Tetanus seroprotection rate
时间窗: 28 to 35 days after vaccine administration
Polio seroprotection rate
时间窗: 28 to 35 days after vaccine administration
次要结局
- Number and proportion of Serious adverse events(From the first visit to the last visit of the subject)
- Unsolicited injection-site adverse reactions and systemic adverse events(From Day 0 to Day 28 following REPEVAX and/or VAXIGRIP vaccination)
- Solicited injection-site reactions, solicited systemic adverse reactions(From Day 0 to Day 7 following REPEVAX vaccination)