Immunogenicity and Safety of a High-Dose Quadrivalent Influenza Vaccine Administered by the Intramuscular Route in Subjects 60 Years of Age and Older - QHD00011

Sanofi-aventis0 个研究点目标入组 340 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Sanofi-aventis
入组人数: 340

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 99（—）

入选标准

•- Sixty years of age and older on the day of inclusion;
•- Able to attend all scheduled visits and to comply with all trial procedures

排除标准

•- Participant is pregnant, or lactating, or of childbearing potential and not
•using an effective method of contraception or abstinence from at least 4 weeks
•prior to vaccination until at least 4 weeks after vaccination. To be considered
•of non-childbearing potential, a female must be post-menopausal for at least 1
•year, or surgically sterile;
•- Participation at the time of study enrollment (or in the 4 weeks [28 days]
•preceding the trial vaccination) or planned participation during the present
•trial period in another clinical trial investigating a vaccine, drug, medical
•device, or medical procedure;
•- Receipt of any vaccine in the 4 weeks (28 days) preceding the trial
•vaccination or planned receipt of any vaccine prior to V02;
•- Previous vaccination against influenza (in the previous 6 months) with either
•the trial vaccine or another vaccine;
•- Receipt of immune globulins, blood or blood-derived products in the past 3
•- Known or suspected congenital or acquired immunodeficiency; or receipt of
•immunosuppressive therapy, such as anti-cancer chemotherapy or radiation
•therapy, within the preceding 6 months; or long-term systemic corticosteroid
•therapy (prednisone or equivalent for more than 2 consecutive weeks within the
•past 3 months);
•- Known systemic hypersensitivity to any of the vaccine components, or history
•of a life-threatening reaction to the vaccines used in the trial or to a
•vaccine containing any of the same substances;
•- Thrombocytopenia or bleeding disorder, contraindicating intramuscular (IM)
•vaccination based on Investigator*s judgement
•- Alcohol or substance abuse that, in the opinion of the Investigator might
•interfere with the trial conduct or completion
•- Chronic illness that, in the opinion of the Investigator, is at a stage where
•it might interfere with trial conduct or completion
•- Moderate or severe acute illness/infection (according to Investigator
•judgment) or febrile illness (temperature * 38.0°C) on the day of vaccination.
•A prospective participant should not be included in the study until the
•condition has resolved or the febrile event has subsided
•- Identified as an Investigator or employee of the Investigator or study center
•with direct involvement in the proposed study, or identified as an immediate
•family member (ie, parent, spouse, natural or adopted child) of the
•Investigator or employee with direct involvement in the proposed study
•- Personal or family history of Guillain Barré syndrome (GBS);
•- Neoplastic disease or any hematologic malignancy (except localized skin or
•prostate cancer that is stable at the time of vaccination in the absence of
•therapy and participants who have a history of neoplastic disease and have been
•disease free for * 5 years)

研究者

发起方

Sanofi-aventis

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