EUCTR2021-005319-30-IT招募中1 期
A phase 3b, open-label, multi-country, multi-centre, long-term follow-up study of ZOSTER-049 (follow-up of ZOSTER-006/022 studies) to assess the prophylactic efficacy, safety and persistence of immune response of a Herpes Zoster subunit vaccine and assessment of persistence of immune response and safety of 1 or 2 additional doses administered in ZOSTER-049 in 2 subgroups of older adults - ZOSTER-101
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 3,662
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
- •Participants and participant’s caregiver, who, in the opinion of the investigator, can and are willing to comply with the requirements of the protocol.
- •Written or witnessed/thumb printed informed consent obtained from the participant of the participant prior to performance of any study-specific procedure.
- •Medically stable participants as established by medical history and clinical examination before entering into the study.
- •Participants who completed ZOSTER-049 study (following at least 1 dose of HZ/su in ZOSTER-006/022 studies).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1356
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2306
排除标准
- •Medical conditions
- •Any clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
- •Prior/Concomitant therapy
- •Use of any investigational or non-registered product (drug, vaccine or medical device) for the treatment of HZ or Varicella Zoster Virus (VZV) infection at the time of enrolment or their planned use during the study period.
- •Previous vaccination against VZV or HZ and/or planned administration during the study of a VZV or HZ vaccine (including an investigational or non-registered vaccine other than HZ/su administered in studies ZOSTER-006/022 or ZOSTER-049).
- •Prior/Concurrent clinical study experience
- •Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/invasive medical device) for the prevention and/or treatment of HZ or VZV and which may have a possible activity against VZV.
研究者
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