EUCTR2021-003804-42-NO进行中（未招募）1 期
Immunogenicity, molecular profiling and safety of a marketed quadrivalent influenza vaccine (Vaxigrip Tetra) administered by the intramuscular route in children 3-11 years old
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1)Healthy children or children with well-controlled pre-existing medical conditions (as concluded from the medical history with a stable regimen for at least 2 weeks prior to study entry , physical examination, and clinical judgment) age range = 3 and = 11 years old.
- •2)Signed informed consent from parents/guardians.
- •3)Parents/guardians able to understand and comply with the study protocol requirements, including availability for all scheduled visits of the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 50
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1)Acute illness, at the time of study vaccine administration (once acute illness is resolved, participants will be re-revaluated for eligibility).
- •2)Recorded fever (for eligibility purpose defined as a body temperature greater than 37.5°C) within 3 days prior to study vaccine administration (once fever/acute illness is resolved, participants will be re-evaluated for eligibility by the investigator).
- •3)Current or previous, laboratory confirmed case of influenza during the past 6 months, based on anamnesis or medical record (if available) at screening visit.
- •4)Household contact with and/or intimate exposure to an individual with any laboratory confirmed influenza infection during the past 6 months prior to vaccination.
- •5)History of severe allergic reactions after previous vaccinations or hypersensitivity to any study vaccine components (ovalbumin, egg proteins), neomycin, formaldehyde or octoxynol-9.
- •6)Previous history of Guillain Barré Syndrome.
- •7)Any confirmed or suspected condition with impaired/altered function of immune system (e.g. immunodeficient or autoimmune conditions).
- •8)Having any bleeding disorder which is considered as a contraindication to intramuscular injection or blood draw according to the opinion of the investigator
- •9)Chronic administration (defined as more than 14 days) of immunosuppressant or other immune-modifying drugs within three months prior to the study vaccination or planned use throughout the study period. (For corticosteroids, this means prednisone, or equivalent, = 0.5 mg/kg per day. Inhaled, intranasal and topical steroids are allowed.
- •10)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 subjects who have a history of neoplastic disease and have been disease-free for =5 years).
- •11)Administration of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 3 months or planned use throughout the study period.
- •12)Administration of any vaccine within 28 days prior to enrolment in the study or planned administration of any vaccine during study participation.
- •13)Use of any investigational or non-registered drug or vaccine within 30 days prior to the administration of study vaccines or planned during the study.
- •14)Having received systemic antibiotic treatment within 3 days prior to enrolment.
- •15)Acute or chronic, clinically significant pulmonary, cardiovascular, metabolic, neurological, hepatic, or renal functional abnormality, as determined by medical history or physical examination if uncontrolled or without appropriate treatment
- •16)Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the volunteer participating in the study or make it unlikely that the participant could complete the protocol.
- •For the second vaccine dose the exclusion criteria are:
- •1)Previous influenza vaccination before study start, as these children only require one vaccination.
- •2)Acute illness, at the time of study vaccine administration (once acute illness is resolved, participants will be re-revaluated for eligibility).
- •3)Recorded fever (for eligibility purpose defined as a body temperature greater than 37.5°C) within 3 days prior to study vaccine administration (once fever/acute illness is resolved, participants will be re-evaluated for eligibility by the investigator).
- •4)History of severe allergic reactions
研究者
相似试验
尚未招募
4 期
Immunity against Influenza virus disease and safety of FluQuadri (marketed vaccine with protection against 4 types of influenza virus) in children of age between 6 and 12 monthsCTRI/2021/10/037161Seth GS Medical College and KEM Hospital
已完成
4 期
Immunity against Influenza virus disease and safety of FluQuadri (marketed vaccine with protection against 4 types of influenza virus) in participants 60 years of age and olderCTRI/2020/09/027913Seth GSMC and KEM Hospital100
尚未招募
4 期
Immunity against Influenza virus disease and safety of FluQuadri (marketed vaccine with protection against 4 types of influenza virus) in children of age between 3 and 8 yearsCTRI/2021/10/037159Seth GS Medical College KEM Hospital
进行中（未招募）
1 期
Immunity to influenza virus disease and safety of Vaxigrip Tetra® (commercial vaccine with protection against 4 types of influenza virus) in participants 60 years and olderInfluenzaEUCTR2021-003307-18-BEniversity of Antwerp50
已完成
1 期
Investigating of the Immunogenicity and Safety of Lactococcus Lactis Vaccine Related to Human Papillomavirus Type 16IRCT20190504043464N1Iran University of Medical Sciences200