ACTRN12617001086358已完成4 期
A prospective pilot study investigating the impact of obesity on seroprotection after influenza vaccination in children aged 9-17 years.
Women's and Children's Hospital0 个研究点目标入组 44 人开始时间: 2017年7月26日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
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
- 9 Years 至 17 Years（—）
- 性别
- All
入选标准
- •All participants must satisfy ALL the following criteria at study entry:
- •1. Participants are healthy children aged between 9-17 years at the time of enrolment.
- •2. Participants who, in the opinion of the study staff, can and will comply with the requirements of the protocol (eg return for follow-up visits, blood collection).
- •3. Participants who can provide assent and have a parent willing to provide consent.
- •Additional criteria specific to cases and controls include:
- •Cases - Obese children (BMI >=95th percentile for age and gender) aged 9-17 years. Total number to be enrolled is 25 cases.
- •Controls - Non-obese children (BMI 5th - <95th percentile for age and gender) aged 9-17 years. Total number to be enrolled is 25 controls.
排除标准
- •Presence of any of the following criteria will exclude the subject from receipt of influenza vaccination as part of the study:
- •1. History of serious medical conditions (eg cardiac, respiratory, renal, hepatic disorders, diabetes mellitus requiring treatment with insulin).
- •2. Any syndromal and/or endocrinological causes for obesity.
- •3. History of seasonal influenza vaccination within the last six months prior to enrolment.
- •4. History of any immunosuppressive condition (eg HIV infection) or on immunosuppressing medication.
- •5. Any contraindication to influenza immunisation according to the Australian Immunisation Handbook.
- •6. Anaphylaxis following a previous dose of any influenza vaccine
- •7. Anaphylaxis following any vaccine component.
- •8. History of egg allergy.
- •9. History of Guillain Barre syndrome.
- •10. Bleeding diathesis or condition associated with prolonged bleeding that may contraindicate intramuscular injection or blood draw.
- •11. Any major illness that, in the investigator’s judgment, will substantially increase the risk associated with the subject’s participation in the study, or interfere with the evaluation of the study objectives.
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