NCT04091451已完成3 期
A Phase III, Randomized, Observer-blind, Placebo Controlled, Multicenter Clinical Trial to Assess Herpes Zoster Recurrence and the Reactogenicity, Safety and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine (HZ/su) When Administered Intramuscularly on a 0 and 2 Month Schedule to Adults ≥50 Years of Age With a Prior Episode of Herpes Zoster
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,430
- 试验地点
- 1
- 主要终点
- Incidence Rate of Confirmed Herpes Zoster (HZ) Cases
研究概览
简要总结
The purpose of this study was to assess the safety and immunogenicity of GSK Biologicals' HZ/su vaccine when given on a two-dose schedule to adults aged 50 years and above who had a previous episode of Herpes Zoster (HZ).
详细描述
The study will be conducted in 2 epochs: Epoch 001- starting from visit day 1, followed by visit month 2 and then Visit 3 at one month post last vaccination (Month 3). Epoch 002- Starting with monthly contact after Visit 3 (Month 3) and ending at 26 months from the enrolment date.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects and/or subject's LAR(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol
- •Written informed consent obtained from the subject/subject's LAR(s) prior to performance of any study specific procedure.
- •A male or female ≥ 50 YOA at the time of the first vaccination.
- •Subjects with a history of HZ. Confirmation of the prior HZ diagnosis can be done by one of the following three methods:
- •Clinically diagnosed HZ:
- •OR Laboratory diagnosed HZ: OR
- •HZ diagnosed by an adjudication committee: Female subjects of non-childbearing potential may be enrolled in the study.
- •Non-childbearing potential is defined as current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy, bilateral salpingectomy or post-menopause.
- •Female subjects of childbearing potential may be enrolled in the study if the subject:
- •has practiced adequate contraception for 30 days prior to vaccination, and
- •has a negative pregnancy test on the day of vaccination, and
- •has agreed to continue adequate contraception for 2 months after completion of the vaccination series.
排除标准
- •Subjects who at time of study entry or during the maximum period of anticipated study participation are/will become part of the population recommended to receive a zoster vaccine per existing local or national immunization practices will be excluded from study participation.
- •Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the first dose of study vaccine, or planned use during the study period.
- •Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
- •Onset of HZ in the past 6 months or any ongoing symptoms from a prior HZ episode.
- •Chronic antiviral use for HZ prophylaxis.
- •History of >1 prior episode of HZ.
- •A history of disseminated HZ, cutaneous or associated with visceral disease or associated with neurologic disease caused by VZV infection.
- •Use or anticipated use of immunosuppressants or immune-modifying drugs during the period starting six months prior to study start and during the whole study period. This includes chronic administration of corticosteroids, long-acting immune-modifying agents or immunosuppressive/cytotoxic therapy
- •Administration or planned administration of a vaccine not foreseen by the study protocol within the period starting 30 days before the first dose of study vaccine and ending 30 days after the last dose of study vaccine. However, licensed pneumococcal vaccines and non-replicating vaccines 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 vaccine.
- •Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product
- •Previous vaccination against VZV or HZ.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
- •Acute disease and/or fever at the time of enrolment.
- •Administration of immunoglobulins and/or any blood products during the period starting 3 months before the first dose of study vaccine or planned administration during the study period.
- •Pregnant or lactating female.
- •Female planning to become pregnant or planning to discontinue contraceptive precautions in the period up to 2 months after completion of the vaccination series.
研究组 & 干预措施
HZ/su Group
Experimental
Participants with a prior episode of HZ randomized to the HZ/su group were scheduled to receive 2 doses of HZ/su vaccine, one at Day 1 and one at Month 2.
干预措施: Herpes Zoster subunit (HZ/su) vaccine (GSK1437173A) (Biological)
Placebo Group
Placebo Comparator
Participants with a prior episode of HZ randomized to the Placebo group were scheduled to receive 2 doses of placebo, one at Day 1 and one at Month 2.
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence Rate of Confirmed Herpes Zoster (HZ) Cases
时间窗: From 30 days post-second vaccination (Month 3) until study end (duration of approximately 2 years to 4 years and 5 months)
A suspected case of HZ is defined as a new unilateral rash accompanied by pain (broadly defined to include allodynia, pruritus or other sensations) and no alternative diagnosis. A suspected case of HZ was confirmed by an algorithm that included Polymerase Chain Reaction (PCR) and the HZ Ascertainment Committee (HZAC) determination. The incidence rate (n/T) of confirmed HZ cases, expressed in terms of 1000 person-years rate, was calculated as the number of participants reporting at least one confirmed HZ case (n) in a group, over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 1000.
次要结局
- Incidence Rate of Confirmed HZ Cases(From first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months))
- Number of Participants With Any and Grade 3 Solicited Administration Site Events(Within 7 days after each vaccination (occurring at Day 1 and Month 2))
- Duration in Days of Solicited Administration Site Events(Within 7 days after each vaccination (occurring at Day 1 and Month 2))
- Number of Participants With Any, Grade 3 and Related Solicited Systemic Events(Within 7 days after each vaccination (occurring at Day 1 and Month 2))
- Duration in Days of Solicited Systemic Events(Within 7 days after each vaccination (occurring at Day 1 and Month 2))
- Number of Participants With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)(Within 30 days after each vaccination (occurring at Day 1 and Month 2))
- Number of Participants With Any and Related Serious Adverse Events (SAEs)(From first vaccination (Day 1) to 30 days post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses))
- Number of Participants With Any and Related Potential Immune-mediated Diseases (pIMDs)(From first vaccination (Day 1) to 30 days post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses))
- Number of Participants With Any and Related SAEs(From 30 days post-last vaccination until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses))
- Number of Participants With Any and Related pIMDs(From 30 days post-last vaccination until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses))
- Number of Participants With SAEs Related to Investigational Vaccine, Related to Study Participation or to GSK Concomitant Medication/Vaccine(From first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months))
- Percentage of Participants With Vaccine Response for Anti-glycoprotein E (Anti-gE) Antibodies as Determined by Enzyme Linked Immunosorbent Assay (ELISA)(At Month 2 and Month 3)
- Anti-gE Antibody Concentrations Expressed as Geometric Mean Concentrations (GMCs) as Determined by ELISA(At Day 1, Month 2 and Month 3)
研究者
研究点 (1)
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