CTRI/2022/02/040060已完成3 期
A phase 3, randomized, observer-blind, placebo- controlled, multi-centre study to evaluate the immune response and safety of the Herpes Zoster subunit vaccine when administered intramuscularly on a 2-dose schedule in adults aged 50 years and older in India. - ZOSTER-081
GlaxoSmithKline Biologicals SA GSK Rue de lInstitut Rixensart0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
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
入选标准
- •All participants must satisfy ALL the following criteria at study entry
- •1 Participants and/or participants LAR who in
- •the opinion of the investigator can and will comply with the requirements of the
- •protocol (e.g. completion of the diary cards return for follow-up visits)
- •2 A male or female aged 50 YOA or older at the time of the first study intervention
- •3 Healthy participants or medically stable patients as established by medical history
- •and clinical examination before entering into the study
- •4 Female participants of non-childbearing potential may be enrolled in the study
- •5 Written or witnessed/thumb printed informed consent obtained from the participant
- •and/or participants LAR(s) after the study has been explained according to local
- •regulatory requirements and prior to performance of any study-specific procedure
- •6 Female participants of childbearing potential may be enrolled in the study if the
- •participant-
- •- has practiced adequate contraception for 1 month prior to study intervention
- •administration and
- •- has a negative pregnancy test on the day of study intervention administration
- •- has agreed to continue adequate contraception during the entire treatment period
- •and for 2 months after completion of the study intervention administration
排除标准
- •The following criteria should be checked at the time of study entry. The potential
- •participant MAY NOT be included in the study if ANY exclusion criterion applies
- •1 MEDICAL CONDITIONS
- •Any other clinical condition that in the opinion of the investigator might pose
- •additional risk to the participant due to participation in the study.
- •History of any reaction or hypersensitivity likely to be exacerbated by any
- •component of the study intervention(s) or study materials or equipment.
- •Acute or chronic clinically significant pulmonary cardiovascular hepatic or renal
- •functional abnormality, as determined by medical history, physical examination or
- •laboratory screening tests.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition,
- •based on medical history and physical examination (no laboratory testing required).
- •History of HZ.
- •Significant underlying illness that in the opinion of the investigator would be
- •expected to prevent completion of the study (e.g. life-threatening disease likely to
- •limit survival to less than 4 years).
- •2 PRIOR CONCOMITANT THERAPY
- •Planned administration/administration of a vaccine not foreseen by the study
- •protocol in the period starting 30 days before first dose and ending 30 days after the
- •last dose of study intervention administration with the exception of licensed
- •pneumococcal vaccines and non-replicating vaccines (i.e. inactivated and subunit
- •vaccines including inactivated and subunit influenza vaccines, with or without
- •adjuvant for seasonal or pandemic flu) may be administered up until 8 days prior to
- •Dose 1 and/or Dose 2 and/or at least 14 days after any dose of study intervention.
- •In case an emergency mass vaccination for an unforeseen public health threat (e.g. a
- •pandemic) is recommended and/or organized by the public health authorities, outside
- •the routine immunization programme, the time period described above can be
- •reduced if necessary for that vaccine provided it is used according to local
- •governmental recommendations and that the Sponsor is notified accordingly.
- •Planned administration of long-acting immune-modifying drugs at any time during
- •the study period (e.g. infliximab).
- •Administration of immunoglobulins and/or any blood products or plasma derivatives
- •during the period starting 3 months before the first dose of study intervention up to
- •1-month post-dose 2 (Month 3) or planned administration during the study period.
- •Chronic administration (defined as more than 14 days in total) of
- •immunosuppressants or other immune-modifying drugs during the period starting 3
- •months prior to the first study intervention dose. For corticosteroids, this will mean
- •prednisone equivalent or greater than 20 mg/day or equivalent is not allowed. Inhaled
- •intra- articular and topical steroids are allowed.
- •Previous vaccination against varicella or HZ.
- •3 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).
- •4 OTHER EXC
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