ISRCTN70837239已完成1 期
Evaluation of heterosubtypic immune responses in older people before and after seasonal and pandemic influenza vaccination
niversity Hospitals of Leicester NHS Trust (UK)0 个研究点目标入组 520 人开始时间: 2010年4月23日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 520
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
- 性别
- All
入选标准
- •1. Healthy subjects aged greater than or equal to 18 years of age, either sex
- •2. Subjects willing to receive vaccine in the trial
- •3. Able to complete informed consent and attend study visits
排除标准
- •1. Receipt of another investigational agent within 4 weeks, or before completion of the safety follow-up period in another study, whichever is longer, prior to enrolment and unwilling to refuse participation in another clinical study through the end of the study
- •2. Subjects who experienced any acute disease or infection requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) within the past 7 days before Visit 1 or any visit where trial vaccination is planned
- •3. Subjects who experienced fever (defined as axillary temperature greater than or equal to 38.0°C) within 3 days prior to Visit 1
- •4. Subjects who are pregnant or breastfeeding
- •5. Females of childbearing potential who refuse to use an acceptable method of birth control for the duration of the study. Adequate contraception is defined as hormonal (e.g., oral, injection, transdermal patch, implant, cervical ring), barrier (e.g., condom with spermicide or diaphragm with spermicide), intrauterine device (e.g., IUD), or monogamous relationship with vasectomized partner who has been vasectomized for 6 months or more prior to the subject's study entry
- •6. Subjects with any serious disease, such as:
- •6.1. Cancer
- •6.2. Autoimmune disease (including rheumatoid arthritis)
- •6.3. Progressive chronic pulmonary disease (stable controlled respiratory disease including asthma is allowed)
- •6.4. Acute or progressive hepatic disease
- •6.5. Acute or progressive renal disease
- •7. Subjects for whom elective surgery is planned during the study period
- •8. Subjects with bleeding diathesis
- •9. Subjects with hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the study vaccine
- •10. Subjects with a history of any neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
- •11. Subjects with known or suspected impairment/alteration of immune function, for example, resulting from:
- •11.1. Receipt of immunosuppressive therapy (any corticosteroid therapy or cancer chemotherapy)
- •11.2. Receipt of immunostimulants
- •11.3. Receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months prior to Visit 1 or planned during the full length of the study
- •11.4. High risk for developing an immunocompromising disease
- •12. Receipt of another vaccine within 3 weeks prior to Visit 1 or planned vaccination within 3 weeks following the last study vaccination
- •13. Subjects with a history of (or current) drug or alcohol abuse that in the investigator's opinion would interfere with safety of the subject or the evaluation of study objectives
- •14. Subjects with any condition, which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives
研究者
相似试验
尚未招募
不适用
Study of host immune response in patients of fungal infection of skin.CTRI/2019/09/021297Indian Association of Dermatologists Venereologists and Leprologists
已完成
Unknown
Correlation of agni and immune response in students during University examinatioCTRI/2023/09/057238DR AKANKSHA D SHIRPURKAR30
尚未招募
4 期
Comparative evaluation of immunogenicity of various schedules and delivery options to provide fractional Dose Inactivated Poliovirus Vaccine in routine immunizatioCTRI/2017/02/007793Panacea Biotec Ltd800
已完成
4 期
Comparition of immunity and reaction of bOPV vaccine and tOPV vaccine in routine immunization schedule, with or without IPV vaccine administration at DTP3 vaccine contact: A controlled trialCTRI/2013/06/003722World health Organization900
已完成
不适用
Comparative evaluation of immunogenicity and reactogenicity of monovalent type 2 and 3 oral poliovirus vaccines (mOPV 2 and mOPV3) versus trivalent oral poliovirus vaccine (tOPV), and bivalent oral poliovirus vaccine (bOPV) versus monovalent types 1 and 3 oral poliovirus vaccines, respectively: a randomised double-blind trialISRCTN64725429Panacea Biotec Limited (India)900