A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Immunogenicity and Safety of Ad26.RSV.preF-based Vaccine and High-dose Seasonal Influenza Vaccine, With and Without Coadministration, in Adults Aged 65 Years and Older
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 777
- 试验地点
- 12
- 主要终点
- Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Against Each of the Four Influenza Vaccine Strains as Measured by HI Assay
研究概览
简要总结
The purpose of this study is to evaluate the immunogenicity and safety of Ad26.RSV.preF-based vaccine and quadrivalent high-dose seasonal influenza vaccine when administered either concomitantly or separately.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to adhere to the prohibitions and restrictions specified in this protocol
- •In the investigator's clinical judgment, the participant must be in stable health at the time of vaccination. Participants will be included on the basis of medical history and vital signs performed between informed consent from (ICF) signature and vaccination
- •Before randomization, a participant must be not intending to conceive by any methods, postmenopausal or surgically sterile
- •From the time of vaccination through 3 months after vaccination, agrees not to donate blood
- •Must be willing to provide verifiable identification, have means to be contacted and to contact the investigator during the study
- •Participant must be able to work with smartphones/tablets/computers
排除标准
- •History of malignancy within 5 years before screening not in the following categories: a) participants with squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix may be enrolled at the discretion of the investigator; b) participants with a history of malignancy within 5 years before screening, with minimal risk of recurrence per investigator's judgement, can be enrolled
- •Known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine)
- •History of severe allergic reactions (example, anaphylaxis) to any component of the Quadrivalent high-dose influenza vaccine, including egg protein, or following a previous dose of any influenza vaccine
- •Has abnormal function of the immune system resulting from either clinical condition, chronic or recurrent use of systemic corticosteroids within 2 months prior to study vaccination, or immunomodulating agents within 6 months prior to study vaccination
- •Per medical history, participant has chronic active hepatitis B or hepatitis C infection
- •History of acute polyneuropathy (example, Guillain-Barre syndrome) or chronic idiopathic demyelinating polyneuropathy
- •Has a serious chronic disorder, example, chronic obstructive pulmonary disease or congestive heart failure, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, Alzheimer's disease, or has any condition, including conditions placing the participant at high risk for severe influenza, for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments
- •Received vaccination with seasonal influenza vaccine for the current influenza season in the Northern Hemisphere
研究组 & 干预措施
Group 1: Coadministration (CoAd) Group
Participants will receive Ad26.RSV.preF-based vaccine and quadrivalent high dose influenza vaccine concomitantly on Day 1 and placebo on Day 29.
干预措施: Ad26.RSV.preF-based vaccine (Biological)
Group 1: Coadministration (CoAd) Group
Participants will receive Ad26.RSV.preF-based vaccine and quadrivalent high dose influenza vaccine concomitantly on Day 1 and placebo on Day 29.
干预措施: Quadrivalent High-dose Influenza Vaccine (Biological)
Group 1: Coadministration (CoAd) Group
Participants will receive Ad26.RSV.preF-based vaccine and quadrivalent high dose influenza vaccine concomitantly on Day 1 and placebo on Day 29.
干预措施: Placebo (Biological)
Group 2: Control Group
Participants will receive placebo and quadrivalent high-dose influenza vaccine on Day 1 and Ad26.RSV.preF-based vaccine on Day 29.
干预措施: Ad26.RSV.preF-based vaccine (Biological)
Group 2: Control Group
Participants will receive placebo and quadrivalent high-dose influenza vaccine on Day 1 and Ad26.RSV.preF-based vaccine on Day 29.
干预措施: Quadrivalent High-dose Influenza Vaccine (Biological)
Group 2: Control Group
Participants will receive placebo and quadrivalent high-dose influenza vaccine on Day 1 and Ad26.RSV.preF-based vaccine on Day 29.
干预措施: Placebo (Biological)
结局指标
主要结局
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Against Each of the Four Influenza Vaccine Strains as Measured by HI Assay
时间窗: 28 days after vaccination with Fluzone on Day 1 (Day 29)
Hemagglutination is a phenomenon by which the hemagglutinin protein of influenza viruses can bind to sialic acid receptors on the red blood cell membrane, thereby forming clumps and is the basis for the HI assay. GMTs of HI antibodies against each of the four influenza vaccine strains as measured by HI assay at 28 days after the administration of a quadrivalent high-dose seasonal influenza vaccine (fluzone) were reported. The analysis was performed on 2 influenza A strains \[A/Victoria and A/Tasmania\] and 2 influenza B strains \[B/Washington and B/Phuket\]).
GMTs of Prefusion F-protein (preF) Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) on Day 29
时间窗: 28 days after vaccination with Ad26.RSV.preF-based vaccine on Day 1 (Day 29)
GMTs of preF antibodies at 28 days after the administration of Ad26.RSV.preF-based vaccine as assessed by ELISA on Day 29 were reported. This outcome measure was planned to be analyzed for specified arm only.
GMTs of PreF Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) on Day 57
时间窗: 28 days after vaccination with Ad26.RSV.preF-based vaccine on Day 29 (Day 57)
GMTs of preF antibodies at 28 days after the administration of Ad26.RSV.preF-based vaccine as assessed by ELISA on Day 57 were reported. This outcome measure was planned to be analyzed for specified arm only.
次要结局
- Number of Participants With Solicited Local AEs After Study Vaccination 2(Up to 7 days after study vaccination 2 on Day 29 (Day 36))
- Number of Participants With Solicited Systemic AEs After Study Vaccination 2(Up to 7 days after study vaccination 2 on Day 29 (Day 36))
- Number of Participants With Unsolicited AEs After Study Vaccination 1(Up to 28 days after study vaccination 1 on Day 1 (Day 29))
- Number of Participants With Solicited Local Adverse Events (AEs) After Study Vaccination 1(Up to 7 days after study vaccination 1 on Day 1 (Day 8))
- Number of Participants With Solicited Systemic AEs After Study Vaccination 1(Up to 7 days after study vaccination 1 on Day 1 (Day 8))
- Number of Participants With Unsolicited AEs After Study Vaccination 2(Up to 28 days after study vaccination 2 on Day 29 (Day 57))
- Number of Participants With Serious Adverse Events (SAEs) Up to Study Vaccination 1(From Day 1 up to Day 29)
- Number of Participants With Serious Adverse Events (SAEs) Up to Study Vaccination 2(From Day 29 up to 6 months after study vaccination 2 (up to 7 months))
- Number of Participants With Adverse Events of Special Interest (AESI) Up to Study Vaccination 2(From Day 29 up to 6 months after study vaccination 2 (up to 7 months))
- Number of Seroconverted Participants After 28 Days of Administration of Influenza Vaccine(28 days after vaccination with fluzone on Day 1 (up to Day 29))
- Number of Participants With Adverse Events of Special Interest (AESI) Up to Study Vaccination 1(From Day 1 up to Day 29)
- Number of Seroprotected Participants After 28 Days of Administration of Influenza Vaccine(28 days after vaccination with fluzone on Day 1 (up to Day 29))