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临床试验/NCT04886596
NCT04886596已完成3 期

A Phase 3, Randomized, Placebo-controlled, Observer-blind, Multi-country Study to Demonstrate the Efficacy of a Single Dose and Annual Revaccination Doses of GSK's RSVPreF3 OA Investigational Vaccine in Adults Aged 60 Years and Above

GlaxoSmithKline1 个研究点 分布在 1 个国家目标入组 26,675 人开始时间: 2021年5月25日最近更新:
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适应症
干预措施
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试验速览

阶段
3 期
状态
已完成
入组人数
26,675
试验地点
1
主要终点
Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated Lower Respiratory Tract Disease (LRTD) During the First Season Following a Single Dose of the RSVPreF3 OA Vaccine
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study will evaluate the efficacy of the RSVPreF3 OA investigational vaccine in preventing Lower Respiratory Tract Disease (LRTD) caused by RSV in adults ≥60 years of age following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses in Northern Hemisphere (NH) and in Southern Hemisphere (SH). This study will also assess if the vaccine is safe and induces an immune response.

详细描述

Dose 1 Period will be conducted in 2 parts: Part 1: Participants in RSVPreF3 groups will receive lots 1, 2 and 3 of the investigational vaccine before Season 1. Part 2: Will be initiated when the vaccine lots in part 1 are exhausted at the study sites and participants in RSVPreF3 group will receive lot 4 of the investigational vaccine before Season 1.

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

This is an observer blind study.

入排标准

年龄范围
60 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
是

入选标准

  • •A male or female ≥ 60 YOA at the time of first vaccination, who live in the community (community dwelling participants) or in a long-term care facility (LTCF participants).
  • •Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
  • •Note: In case of physical incapacity that would preclude the self-completion of the diary cards and/or questionnaires, either site staff can assist the participant (for activities performed during site visits) or the participant may assign a caregiver to assist him/her with this activity (for activities performed at home or in the LTCF). However, at no time, the site staff or caregiver will evaluate the participant's health status while answering diaries and/or questionnaires or make decisions on behalf of the participant
  • •Written or witnessed informed consent obtained from the participant prior to performance of any study specific procedure.
  • •Participants who are medically stable in the opinion of the investigator at the time of first vaccination. Participants with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease, are allowed to participate in this study if considered by the investigator as medically stable.

排除标准

  • •Medical conditions
  • •Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination (no laboratory testing required).
  • •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
  • •Hypersensitivity to latex.
  • •Serious or unstable chronic illness.
  • •Any history of dementia or any medical condition that moderately or severely impairs cognition.
  • •Note: If deemed necessary for clinical evaluation, the investigator can use tools such as Mini-Mental State Exam (MMSE), Mini-Cog or Montreal Cognitive Assessment (MoCA) to determine cognition levels of the participant.
  • •Recurrent or un-controlled neurological disorders or seizures. Participants with medically-controlled active neurological diseases can be enrolled in the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol.
  • •Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.
  • •Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
  • •Prior/Concomitant therapy
  • •Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study vaccine during the period beginning 30 days before the first study vaccine administration, or planned use during the study period.
  • •Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before each dose and ending 30 days after each dose of study vaccine administration, with the exception of inactivated and subunit influenza vaccines which can be administered up to 14 days before or from 14 days after each study vaccination.
  • •Previous vaccination with an RSV vaccine.
  • •Administration of long-acting immune-modifying drugs or planned administration at any time during the study period.
  • •Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the first study vaccine or planned administration during the study period.
  • •Chronic administration (defined as more than 14 consecutive days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to the first study vaccine administration or planned administration during the study period. For corticosteroids, this will mean prednisone ≥20 mg/day, or equivalent. Inhaled and topical steroids are allowed.
  • •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 vaccine/product (drug or medical device).
  • •Other exclusions
  • •History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures.
  • •Bedridden participants.
  • •Planned move during the study period that will prohibit participating in the trial until study end. This includes:
  • •Planned move during the study period to another LTCF that will prohibit participation in the trial until study end.
  • •Planned move from the community to a LTCF that will prohibit participation in the trial until study end.
  • •Participation of any study personnel or their immediate dependants, family, or household members.
  • •Planned leave or holiday of 4 consecutive weeks or more during the RSV seasons* covered by the study, that would prohibit the reporting of ARI cases and attendance to ARI visit.
  • •RSV seasons are from October to April in NH and from March to September in SH.

研究组 & 干预措施

RSVPreF3 Group

Experimental

Participants received a single dose of the RSVPreF3 OA vaccine at Day 1. Before the second vaccination participants in this group were re-randomized into 2 as: a group that received placebo every subsequent year, and a group that received an additional dose of RSVPreF3 OA vaccine every subsequent year of the study.

干预措施: RSVPreF3 OA vaccine (Biological)

Placebo Group

Placebo Comparator

Participants received 1 dose of placebo at Day 1 and an additional dose of placebo every subsequent year of the study.

干预措施: Placebo (Biological)

结局指标

主要结局

Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated Lower Respiratory Tract Disease (LRTD) During the First Season Following a Single Dose of the RSVPreF3 OA Vaccine

时间窗: From Day 15 post-vaccination up to end of season 1 in the Northern Hemisphere (NH) [a median of approximately 6.7 months (6.9 months in NH and 3.5 months in Southern Hemisphere [SH])]

First episode of Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated LRTD during the first season was assessed. The case definition for RSV-confirmed LRTD is as follows: Presence of at least one RSV-positive swab detected by RT-PCR.

次要结局

  • Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD Over Several Seasons Following a Single Dose of the RSVPreF3 OA Vaccine(From Day 15 post first vaccination up to end of season 2 and up to end of season 3 in the Northern Hemisphere [NH] (assessed approximately over 2 and 3 years in NH))
  • Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD Over Several Seasons Following Annual Revaccination Doses of the RSVPreF3 OA Vaccine(From Day 15 post first vaccination up to end of season 2 and up to end of season 3 in the NH (assessed approximately over 2 and 3 years in NH))
  • Number of Participants With First Episode of RT-PCR Confirmed RSV Subtype A and Subtype B LRTD Over 3 Seasons Following a Single Dose of the RSVPreF3 OA Vaccine(From Day 15 post first vaccination up to end of season 3 in the NH (assessed approximately over 3 years in NH, and 2.5-3 years in SH))
  • Number of Participants With First Episode of RT-PCR Confirmed RSV Subtype A and Subtype B LRTD Over 3 Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following 1 Annual Revaccination Dose(From Day 15 post first vaccination up to end of season 3 in the NH (assessed approximately over 3 years in NH, and 2.5-3 years in SH))
  • Number of Participants With First Episode of RT-PCR Confirmed LRTD Caused by Human Metapneumovirus (hMPV) up to the End of Season 1 Following a Single Dose of the RSVPreF3 OA Vaccine(From Day 15 post-vaccination up to end of season 1 in the SH [a median of approximately 11.5 months (11.6 months in NH and 9.1 months in SH)])
  • Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD, by Age Categories Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses(From Day 15 post first vaccination up to end of season 3 in the NH (assessed approximately over 3 years in NH and 2.5-3 years in SH))
  • Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by RSV Season Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses(From Day 15 post first dose or start of the RSV season to the first occurrence of RSV-confirmed LRTD at each RSV season (assessed approximately over 7 months at each season [Seasons 1 and 2 in SH, Seasons 1, 2 and 3 in NH]))
  • Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Year Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses(From Day 15 post first dose and each revaccination dose up to next dose or end of study (assessed approximately over a year after each vaccination [at Year 1, Year 2 and Year 3]))
  • Number of Participants With First Episode of RT-PCR Confirmed RSV A and /or B Associated LRTD, Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses(From Day 15 post first dose to the first occurrence of RSV LRTD (assessed approximately over 3 years in the NH and 2.5-3 years in SH))
  • Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Comorbidities Using Charlson Comorbidity Index Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses(From Day 15 post first vaccination up to end of season 3 in the NH (assessed approximately over 3 years in NH and 2.5-3 years in SH))
  • Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Comorbidities According to Comorbidities of Interest Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses(From Day 15 post first vaccination up to end of season 3 in the NH (assessed approximately over 3 years in NH and 2.5-3 years in SH))
  • Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Frailty Status Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses(From Day 15 post first vaccination up to end of season 3 in the NH (assessed approximately over 3 years in NH and 2.5-3 years in SH))
  • Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated Severe LRTD Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses(From Day 15 post first vaccination up to end of season 3 in the NH (assessed approximately over 3 years in NH and 2.5-3 years in SH))
  • Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses(From Day 15 post first vaccination up to end of season 3 in the NH (assessed approximately over 3 years in NH and 2.5-3 years in SH))
  • Number of Participants With First Episode of Any ARI or Any LRTD Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses(From Day 15 post first vaccination up to study end (approximately 3 years for NH and 2.5-3 years for SH))
  • Number of Hospitalizations Due to RSV-confirmed Respiratory Diseases or Due to Complication Related to RSV-confirmed Respiratory Diseases, Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study(From Day 15 post-first vaccination up to study end (approximately 3 years for NH and 2.5-3 years for SH))
  • Number of Hospitalizations Due to Any Respiratory Diseases or Due to a Complication Related to Any Respiratory Diseases, During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study(From Day 15 post-first vaccination up to study end (approximately 3 years for NH and 2.5-3 years for SH))
  • Number of Complications Related to RSV-confirmed ARI During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study(From Day 15 post-first vaccination up to study end (approximately 3 years for NH and 2.5-3 years for SH))
  • Number of Complications Related to Any ARI During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study(From Day 15 post-first vaccination up to study end (approximately 3 years for NH and 2.5-3 years for SH))
  • Maximum Influenza Patient-Reported Outcome (Flu-PRO) Chest Score for the Participants With RT-PCR-confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses(During the first 7 days from the onset of ARI symptoms (assessed from Day 15 post first vaccination dose until end of study [approximately 3 years in NH and 2.5-3 years in SH]))
  • Least Square Mean Flu-PRO Total Score for the Participants With RT-PCR-confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses(During the first 7 days from the onset of ARI symptoms (assessed from Day 15 post first vaccination dose until end of study [approximately 3 years in NH and 2.5-3 years in SH]))
  • EuroQol 5-dimension Health Questionnaire (EQ-5D) Utility Score for Participants With RT-PCR-confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses(At the ARI visit (assessed from Day 15 post first vaccination dose until end of study- approximately 3 years in NH and 2.5-3 years in SH))
  • Least Square Mean of Short Form-12 (SF-12) Health Survey for Participants With RT-PCR Confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses(At the ARI visit (assessed from one-month post first vaccination dose until end of study- approximately 3 years in NH and 2.5-3 years in SH))
  • Duration in Days of RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes(From Day 15 post first dose to end of Season 1, from 15 days post-second dose administration to end of Season 2, and from start to end of Season 3 [all seasons summing approximately 3 years in NH and 2.5-3 years in SH])
  • Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 1(From Day 15 post-dose 1 administration up to end of season 1 in the SH [a median of approximately 11.5 months (11.6 months in NH and 9.1 months in SH)])
  • Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2(From Day 15 post-dose 2 administration up to end of Season 2 in SH (a median of approximately 11.9 months [11.9 months in NH and 7.5 months in SH]))
  • Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3(From start of Season 3 up to end of Season 3 in NH (a median of approximately 7 months))
  • Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 1(From Day 15 post-dose 1 administration up to end of season 1 in the SH [a median of approximately 11.5 months (11.6 months in NH and 9.1 months in SH)])
  • Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2(From Day 15 post-dose 2 administration up to end of Season 2 in SH (a median of approximately 11.9 months [11.9 months in NH and 7.5 months in SH]))
  • Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3(From start of Season 3 up to end of Season 3 in NH (a median of approximately 7 months))
  • Number of Participants With RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes According to Severity(Assessed during the study period (approximately 3 years for NH and 2.5-3 years for SH))
  • RSVPreF3 Specific Immunoglobulin G(IgG) Antibody Concentrations(At pre-dose 1 (Day 1), Day 31 post-dose 1, pre-season 2 (approximately 10-17 months post Day 1 in NH; 12-21 months post Day 1 in SH) and pre-season 3 (approximately 24-27 months post Day 1, only in NH))
  • RSV A Neutralizing Antibody Titers(At pre-dose 1 (Day 1), Day 31 post-dose 1, pre-season 2 (approximately 10-17 months post Day 1 in NH; 12-21 months post Day 1 in SH) and pre-season 3 (approximately 24-27 months post Day 1, only in NH))
  • RSV B Neutralizing Antibody Titers(At pre-dose 1 (Day 1), Day 31 post-dose 1, pre-season 2 (approximately 10-17 months post Day 1 in NH; 12-21 months post Day 1 in SH) and pre-season 3 (approximately 24-27 months post Day 1, only in NH))
  • Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events(During the 4-day follow up period after first vaccination (Day 1), second vaccination (administered pre-season 2) and after the third vaccination (administered pre-season 3 -only applicable for participants in NH]))
  • Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events(During the 4-day follow up period after first vaccination (Day 1), second vaccination (administered pre-season 2) and after the third vaccination (administered pre-season 3 -only applicable for participants in NH]))
  • Number of Days With Solicited Administration Site Adverse Events(During the 4-day follow up period after first vaccination (Day 1), second vaccination (administered pre-season 2) and after the third vaccination (administered pre-season 3 -only applicable for participants in NH]))
  • Number of Days With Solicited Systemic Adverse Events(During the 4-day follow up period after first vaccination (Day 1), second vaccination (administered pre-season 2) and after the third vaccination (administered pre-season 3 -only applicable for participants in NH]))
  • Number of Participants With Any Unsolicited AEs(During the 30-day follow up period after first vaccination (Day 1), second vaccination (administered pre-season 2) and after the third vaccination (administered pre-season 3 -only applicable for participants in NH))
  • Number of Participants With Serious Adverse Events (SAEs)(From the day of the vaccination up to 6 months after each vaccination (first vaccination: at Day 1, second vaccination: at pre-season 2 and the third vaccination: at pre-season 3 -only applicable for participants in NH]))
  • Number of Participants With Potential Immune Mediated Diseases (pIMDs)(From the day of the vaccination up to 6 months after each vaccination (first vaccination: at Day 1, second vaccination: at pre-season 2 and the third vaccination: at pre-season 3 -only applicable for participants in NH]))
  • Number of Participants With Related SAEs(From Day 1 up to study end (approximately 3 years for NH and 2.5-3 years for SH))
  • Number of Participants With Fatal SAEs(From Day 1 up to study end (approximately 3 years for NH and 2.5-3 years for SH))
  • Number of Participants With Related pIMDs(From Day 1 up to study end (approximately 3 years for NH and 2.5-3 years for SH))

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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