NCT05219253已完成3 期
A Phase 3, Randomised, 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
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
- 288
- 试验地点
- 1
- 主要终点
- Percentage of Participants Showing a Vaccine Response for Anti-glycoprotein E (gE)
研究概览
简要总结
The purpose of this study was to evaluate the humoral immunogenicity and safety of 2 doses of GSK Biologicals' Herpes Zoster subunit vaccine (HZ/su) administered for the prevention of Herpes Zoster (HZ) in adults aged 50 years of age (YOA) or older from India.
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)
盲法说明
Data was collected in an observer-blind manner.
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
- •Participants and/or participant's legally acceptable representative(s) (LAR) who in the opinion of the investigator, can and will comply with the requirements of the protocol.
- •Written or witnessed/thumb printed informed consent obtained from the participant and/or participant's LAR(s) after the study has been explained according to local regulatory requirements and prior to performance of any study-specific procedure.
- •A male or female aged 50 YOA or older at the time of the first study intervention.
- •Healthy participants or medically stable patients as established by medical history and clinical examination before entering into the study.
- •Female participants of non-childbearing potential may be enrolled in the study.
- •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, and
- •has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the study intervention administration series.
排除标准
- •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) vaccine or study materials or equipment.
- •Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by 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.
- •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 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 organised by the public health authorities, outside the routine immunisation 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.
- •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 vaccine. For corticosteroids, this will mean prednisone equivalent ≥ 20 mg/day or equivalent is not allowed. Inhaled, intra-articular and topical steroids are allowed.
- •Previous vaccination against varicella or HZ.
- •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).
- •Other exclusions
- •Pregnant or lactating female.
- •Female planning to become pregnant or planning to discontinue contraceptive precautions within 2 months of last study intervention administration.
- •Indications of drug abuse or excess alcohol use as deemed by investigator to potentially confound safety assessments or render participant unable or unlikely to adhere to protocol requirements.
研究组 & 干预措施
HZ/su Group
Experimental
Participants randomized to the HZ/su group received two doses of HZ/su vaccine, administered at Day 1 and Month 2.
干预措施: HZ/su (Biological)
Placebo Group
Placebo Comparator
Participants randomized to the Placebo group received two doses of Placebo, administered at Day 1 and Month 2.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Showing a Vaccine Response for Anti-glycoprotein E (gE)
时间窗: At 1 month post-Dose 2 of study intervention administration (Month 3)
A participant with vaccine response for anti-gE was defined as a participant with: * at least a 4-fold greater post-last vaccination anti-gE antibody (Ab) concentration as compared to the pre-vaccination anti-gE Ab concentration, for participants who were seropositive at baseline, or * at least a 4-fold greater post-last vaccination anti-gE Ab concentration as compared to the anti-gE Ab cut-off value for seropositivity, for participants who were seronegative at baseline.
次要结局
- Percentage of Participants Reporting Solicited Administration Site Events(Within 7 days after each study intervention dose and across doses (vaccine/placebo administered at Day 1 and Month 2))
- Percentage of Participants Reporting Unsolicited Adverse Events (AEs)(Within 30 days after any study intervention dose administration (vaccine/placebo administered at Day 1 and Month 2))
- Percentage of Participants Reporting Serious Adverse Events (SAEs)(From Dose 1 (Day 1) up to 30 days post-last study intervention dose)
- Percentage of Participants Reporting Potential Immune-mediated Diseases (pIMDs)(From Dose 1 (Day 1) up to 30 days post-last study intervention dose)
- Percentage of Participants Reporting SAEs(From Dose 1 (Day 1) up to study end (Month 8))
- Anti-gE Antibody Concentrations Expressed as Geometric Mean Concentrations (GMCs) and Between-group GMC Ratios(At 1 month post-Dose 2 of study intervention administration (Month 3))
- Percentage of Participants Reporting Solicited Systemic Events(Within 7 days after each study intervention dose and across doses (vaccine/placebo administered at Day 1 and Month 2))
- Anti-gE Antibody Concentrations Expressed as GMCs(At pre-study intervention administration (Day 1) and at 1 month post-Dose 2 of study intervention administration (Month 3))
- Percentage of Participants Seropositive for Anti-gE Antibodies(At pre-study intervention administration (Day 1) and at 1 month post-Dose 2 of study intervention administration (Month 3))
- Percentage of Participants Reporting pIMDs(From Dose 1 (Day 1) up to study end (Month 8))
- Mean Geometric Increase (MGI) of Anti-gE Antibody Concentrations(At 1 month post-Dose 2 of study intervention administration (Month 3) compared to pre-study intervention administration (Day 1))
研究者
研究点 (1)
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