NCT05559476已完成3 期
A Phase 3, Open-label, Randomized, Controlled, Multicountry Study to Evaluate the Immune Response, Safety and Reactogenicity of RSVPreF3 OA Investigational Vaccine When Co-administered With FLU HD Vaccine in Adults Aged 65 Years and Above
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
- 1,029
- 试验地点
- 1
- 主要终点
- RSV-A Neutralizing Titers Expressed as Group Geometric Mean Titers (GMTs)
研究概览
简要总结
The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the RSVPreF3 OA investigational vaccine when co-administered with the high dose quadrivalent influenza (FLU HD) vaccine in adults aged 65 years and above compared to separate administration of the vaccines.
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
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol
- •A male or female ≥65 years of age at the time of the first study intervention administration.
- •Participants living in the general community or in an assisted-living facility that provides minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living.
- •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 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 vaccines.
- •Hypersensitivity to latex.
- •History of Guillain Barré syndrome, or anaphylaxis.
- •Serious or unstable chronic illness.
- •Any history of dementia or any medical condition that moderately or severely impairs cognition.
- •Recurrent or un-controlled neurological disorders or seizures. Participants with medically-controlled active or chronic 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 (e.g. completion of diary cards, attend regular phone calls/study site visits).
- •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 interventions during the period beginning 30 days before the first study vaccine administration, or planned use during the study period.
- •Administration of an influenza vaccine during the 6 months preceding the study FLU vaccine administration.
- •Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first study intervention administration and ending 30 days after the last study intervention administration.
- •Note: 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 program, the time period described above can be reduced if necessary for that vaccine provided it is used according to the local governmental recommendations and that the Sponsor is notified accordingly.
- •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 dose of 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 vaccination 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 intervention (drug/invasive 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.
- •Planned move during the study conduct that prohibits participation until 1 month post-last vaccine administration.
- •Bedridden participants.
- •Participation of any study personnel or their immediate dependents, family, or household members.
研究组 & 干预措施
Co-Ad Group
Experimental
Participants received one dose of FLU-HD vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.
干预措施: RSVPreF3 OA investigational vaccine (Biological)
Co-Ad Group
Experimental
Participants received one dose of FLU-HD vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.
干预措施: FLU HD vaccine (Biological)
Control Group
Active Comparator
Participants received one dose of FLU-HD vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until the study end.
干预措施: RSVPreF3 OA investigational vaccine (Biological)
Control Group
Active Comparator
Participants received one dose of FLU-HD vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until the study end.
干预措施: FLU HD vaccine (Biological)
结局指标
主要结局
RSV-A Neutralizing Titers Expressed as Group Geometric Mean Titers (GMTs)
时间窗: At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group)
RSV-A neutralizing titers were given as group GMTs and expressed as Estimated Dilution 60 (ED60).
Hemagglutinin Inhibition (HI) Titers for 4 FLU Vaccine Strains Expressed as Group GMTs
时间窗: At 1 month after the FLU vaccine dose (Day 31 for both groups)
HI titers were assessed against the Flu A/Darwin/6/2021 H3N2, Flu A/Victoria/2570/2019 H1N1, Flu B/Austria/1359417/2021 Victoria, and Flu B/Phuket/3073/2013 Yamagata strains.
RSV-B Neutralizing Titers Expressed as Group GMTs
时间窗: At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group)
RSV-B neutralizing titers were given as group GMTs and expressed as Estimated Dilution 60 (ED60).
次要结局
- HI Titers for Each of the 4 FLU Vaccine Strains Expressed as GMT(At Day 1 and 1 month after FLU vaccine dose administration (Day 31 for both groups))
- HI Seroprotection Rate (SPR) for 4 FLU Vaccine Strains(At Day 1 and 1 month after FLU vaccine dose administration (Day 31 for both groups))
- HI Titers for 4 FLU Vaccine Strains, Expressed as MGI(At 1 month after the FLU vaccine dose administration (Day 31 for both groups))
- HI Seroconversion Rate (SCR) for 4 FLU Vaccine Strains(At 1 month after the FLU vaccine dose (Day 31 for both groups))
- Percentage of Participants Reporting Each Solicited Systemic Event After Each Vaccine Dose Administration(Within 4 days (the day of vaccination and 3 subsequent days) after each vaccination (administered on Day 1 and 31))
- RSV-A Neutralizing Titers Expressed as Mean Geometric Increase (MGI)(At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group) compared to pre-vaccination (Day 1 for Co-Ad group and Day 31 for Control group))
- RSV-B Neutralizing Titers Expressed as MGI(At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group) compared to pre-vaccination (Day 1 for Co-Ad group and Day 31 for Control group))
- Percentage of Participants With Solicited Administration Site Events After Each Vaccine Dose Administration(Within 4 days (the day of vaccination and 3 subsequent days) after each vaccination (administered on Day 1 and 31))
- Percentage of Participants Reporting Unsolicited Adverse Events (AEs)(Within 30 days after vaccine administration (the day of vaccination and 29 subsequent days after vaccination))
- Percentage of Participants Reporting Serious Adverse Events (SAEs)(From Day 1 up to study end (6 months after last vaccination - Month 6 for Co-Ad Group and Month 7 for Control group))
- Percentage of Participants Reporting Potential Immune-mediated Disease (pIMDs)(From Day 1 up to study end (6 months after last vaccination - Month 6 for Co-Ad Group and Month 7 for Control group))
研究者
研究点 (1)
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