PACTR202101499206800招募中3 期
A randomized, observer-blind, non-inferiority trial to evaluatealternative human papillomavirus (HPV) vaccination schedules in females in West Africa
Medical Research Council Unit The Gambia at LSHTM0 个研究点目标入组 1,720 人开始时间: 2020年7月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,720
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
- 年龄范围
- 6 Year(s) 至 12 Year(s)（—）
- 性别
- Female
入选标准
- •Signed/thumb-printed informed consent obtained from the participant’s parent (4 to 17 year-olds) or signed/thumb-printed informed consent obtained from the participant (18 years and above)
- •Signed/thumb-printed assent obtained from the participant (12 to 17 year-olds only).
- •Documented verbal assent obtained from the participant (6 to 11 year-olds only)
- •Participant is of female sex (based on participant/parent self-report)
- •Participant is between 4 and 26 years of age inclusive
- •Parent/participant is willing and judged able to comply with the necessary study procedures
- •Parent/participant does not have established plans to leave the study area for a prolonged period/indefinitely during the 3 year follow-up period
- •Participant is resident within the study area (no fixed boundaries will be set and decisions will be made on a case-by-case basis by the study team taking into account not only distance but also transport links, accessibility for the purposes of safety data collection, willingness of the parent/participant to travel)
- •Place of residence of the participant must be readily identifiable
排除标准
- •Receipt of other investigational medicinal products (IMP) in a period of 12 months prior to the day of randomization and vaccination or plans to receive IMP during the trial.
- •Presence of significant chronic health problems requiring long-term medication or medical follow-up including respiratory, cardiac, gastrointestinal, hepatic, renal, neurological, musculoskeletal, haematological or other conditions based on parental history and physical examination of the participant20. Participants with known sickle cell disease (but not sickle cell trait) will be excluded.
- •History of severe allergic reactions to any prior vaccine or to any component of the study vaccine (including alum (amorphous aluminum hydroxyphosphate sulphate), yeast or Benzonase). Severe allergic reactions are defined as reactions requiring urgent medical intervention including reactions with any degree of cardiorespiratory compromise. The occurrence of a mild rash without other associated symptoms or signs does not generally represent an exclusion. Allergic reactions should be distinguished from the local and systemic reactogenicity expected in the first few days following vaccination which is not an exclusion to vaccination
- •Prior receipt of an HPV vaccine
- •Receipt of any vaccine in the 28 days prior to randomization and vaccination‡
- •History of thrombocytopenia or coagulation disorders which represent contraindications in intramuscular (IM) vaccination
- •Known congenital or acquired immune deficiency or history strongly indicative of abnormal immune function. HIV testing will not be undertaken as part of the routine screening procedures due to the relatively low prevalence of HIV expected in the population (~1-3%) and the established safety and immunogenicity profile of Gardasil in HIV positive individuals [167-171].
- •Receipt of medications or other treatments known to suppress the immune system in a period of 12 months prior to the day of randomization or plans to receive such medications and treatments
研究者
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