ACTRN12622001185752招募中4 期
Optimising Q fever vaccination in Australia: Protecting our rural adolescents. Safety and immunogenicity of Q fever vaccine (Q-VAX®) in children aged 10 to <15 years.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 1,100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Prevention
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 10 Years 至 30 Years（—）
- 性别
- All
入选标准
- •For participants Aged >=15 to <=30 years (young adult cohort):
- •1. Willing and capable of providing written informed consent prior to the performance of any study-specific procedure: for participants Aged >=15 to <=30 years.
- •For participants ages 10 to <15 years (adolescent cohort):
- •2. Parents/ guardians willing and capable of providing written informed consent prior to the
- •performance of any study-specific procedure.
- •3. Aged 10 to <15 years (adolescent cohort) or Aged >=15 to <=30 years (young adult cohort) at the time of consent.
- •4. The participant must be in good health as determined by the investigator and/or study nurse, As established by pertinent medical history, physical examination and vital signs assessments performed at Screening.
- •5. The participant must be negative for both Q fever serology and skin test conducted at
- •screening visit prior to vaccination.
- •6. The participant and parent must be able to attend all scheduled visits and to understand and comply with planned study procedures, in the Investigator’s judgement.
排除标准
- •1. History of any major (per Investigator’s discretion) cardiovascular, renal, neurological, metabolic, gastrointestinal, hepato-biliary, uncontrolled hypertension and diabetes, clinically significant chronic pulmonary disease, immunological and autoimmune diseases or any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
- •2. History of / or current egg allergy.
- •3. Chronic use (more than 14 continuous days) of systemic corticosteroids within 30 days prior to Screening. Intra-articular, intra-bursal, or topical (skin or eyes) corticosteroids are permitted.
- •4. History of any haematological malignancy or active neoplastic disease (excluding nonmelanoma skin cancer that was successfully treated). Active is defined as having received treatment within the past 5 years.
- •5. History of clinically significant neurological disease (excluding simple febrile seizures), demyelinating disease or Guillain Barre syndrome.
- •6. Eczema or other significant skin lesion, infection or tattoo at the site of vaccination (left or right upper arm).
- •7. History of blood dyscrasia or significant disorder of coagulation that, in the opinion of the Investigator, contraindicates IM injection.
- •8. History of known or suspected hypersensitivity or any severe allergic reaction including anaphylaxis, generalised urticaria, angioedema, and other significant reaction to Q fever vaccine or any vaccine component, including egg protein, thiomersal or residues carried over from manufacture (such as formalin).
- •9. Presence of active viral or bacterial infection, with or without fever (oral temperature >=37.8 °C) at Screening or within 72 hours prior to vaccination, if determined by the Investigator to be of clinical significance (enrolment may be delayed for full recovery if acceptable to the Investigator).
- •10. Participating in any other clinical study and have received any other investigational product (i.e. study vaccine, drug, biologic or device) within 30 days or 5 half-lives (whichever is longer) prior to Screening, or are taking part in a non medication study which, in the opinion of the Investigator, would interfere with the interpretation of the assessments in this study.
- •11. Received or plans to receive a live-attenuated vaccine within 4 weeks before or after each study vaccination.
- •12. Received or plans to receive an inactivated vaccine within 2 weeks before or after study vaccination.
- •13. Received immunoglobulins and/or any blood or blood products within 3 months before vaccination or plans to receive any blood or blood products at any time during the study.
- •14. Has any psychiatric or cognitive disease that, in the opinion of the Investigator, may interfere with the participant's ability to participate in the study.
- •15. Contraindications to Q fever vaccination as listed in the current NHMRC Australian Immunisation Handbook 10th Edition or as listed in the Q-VAX Product Information.
- •16. History of medical documentation that supports a previous diagnosis of Q fever infection or history of previous Q fever vaccination.
- •17. Females known to be or planning on being pregnant at the time of vaccination.
研究者
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