JPRN-jRCT2051200067已完成3 期
Immunogenicity and Safety of High-Dose Quadrivalent Influenza Vaccine (SP0178) Administered by Intramuscular Route versus Standard-Dose Quadrivalent Influenza Vaccine by Subcutaneous Route in Subjects 60 Years of Age and Older in Japan
Tanaka Tomoyuki0 个研究点目标入组 2,100 人开始时间: 2020年10月20日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,100
研究概览
简要总结
QIV-HD administered by IM route was superior to QIV-SD administered by SC route in terms of HAI GMTs and seroconversion rates for the 4 virus strains contained in QIV SD 28 days post-vaccination in all subjects 60 years of age and older. The vaccination with QIV-HD was found to be safe and well tolerated among subjects 60 years of age and older, with no safety concerns compared with QIV-SD.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 60age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Aged >= 60 years on the day of inclusion
- •- Able to attend all scheduled visits and to comply with all study procedures
排除标准
- •- Participation at the time of study enrollment (or in the 4 weeks preceding the study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
- •- Receipt of any vaccination with live vaccines within the past 27 days preceding the study vaccination or any vaccination with inactivated vaccines within the past 6 days preceding the study vaccination, or planned receipt of any vaccine prior to V02
- •- Previous vaccination against influenza (in the preceding 6 months) with either the study vaccine or another vaccine
- •- Receipt of immune globulins, blood or blood-derived products in the past 3 months
- •- 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 eggs, chicken proteins, or any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the study or to a vaccine containing any of the same substances
- •- Thrombocytopenia or bleeding disorder, contraindicating intramuscular (IM) vaccination based on Investigator's judgment
- •- Alcohol or substance abuse that, in the opinion of the Investigator might interfere with the study conduct or completion.
- •- Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion
- •- 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 (i.e.,parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study
- •- Personal or family history of Guillain-Barre syndrome
- •- 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)
- •- Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature >=37.5 C). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
- •- History of convulsions
- •- Any condition that in the opinion of the Investigator could interfere with the evaluation of the vaccine
研究者
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