NCT05568797已完成3 期
A Phase III, Open-label, Randomized, Controlled, Multi-country Study to Evaluate the Immune Response, Safety and Reactogenicity of an RSVPreF3 OA Investigational Vaccine When Co-administered With FLU aQIV (Inactivated Influenza Vaccine - Adjuvanted) 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
- 1,045
- 试验地点
- 1
- 主要终点
- Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 FLU Vaccine Strains Expressed as Group Geometric Mean Titers (GMTs) at 1 Month After FLU Vaccine Dose
研究概览
简要总结
The aim of this study is to assess the immunogenicity, safety and reactogenicity of the RSV PreFusion protein 3 older adult (RSVPreF3 OA) investigational vaccine when co-administered with an adjuvanted quadrivalent influenza (FLU aQIV) vaccine, in adults aged 65 years of age (YOA).
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 (e.g., completion of the electronic diary cards [eDiaries], return for follow-up visits, ability to access and utilize a phone or other electronic communications).
- •A male or female ≥ 65 YOA 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 study intervention administration. 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 study interventions, in particular any history of severe allergic reaction to egg protein or to a previous influenza vaccine.
- •Hypersensitivity to latex.
- •Guillain-Barré syndrome that occurred within 6 weeks of receipt of prior influenza vaccine.
- •Serious or unstable chronic illness.
- •Any history of dementia or any medical condition that moderately or severely impairs cognition.
- •Recurrent or uncontrolled 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.
- •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 dose of study interventions, 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. In the case of COVID-19 vaccines, this time window can be decreased to 14 days before and after each study intervention administration provided this COVID-19 vaccine use is in line with local governmental recommendations.
- •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 administration of first dose of study interventions 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 intervention dose 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 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.
- •Bedridden participants.
- •Planned move during the study conduct that prohibits participation until study end.
- •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-aQIV 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 vaccine (Biological)
Co-Ad Group
Experimental
Participants received one dose of FLU-aQIV 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 vaccine (Biological)
Control Group
Active Comparator
Participants received one dose of FLU-aQIV vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until end of study.
干预措施: RSVPreF3 OA vaccine (Biological)
Control Group
Active Comparator
Participants received one dose of FLU-aQIV vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until end of study.
干预措施: FLU vaccine (Biological)
结局指标
主要结局
Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 FLU Vaccine Strains Expressed as Group Geometric Mean Titers (GMTs) at 1 Month After FLU Vaccine Dose
时间窗: At 1 month after the FLU vaccine dose (Day 31 for both groups)
HI antibodies assessed were antibodies 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 flu strains.
RSV-B Neutralizing Antibody Titers Expressed as GMTs
时间窗: At 1 month after the RSVPreF3 OA dose (Day 31 for the CoAd Group and Day 61 for the Control Group)
RSV B neutralizing antibodies are given as GMTs and expressed as Estimated Dilution 60 (ED60).
RSV-A Neutralizing Antibody Titers Expressed as GMTs
时间窗: At 1 month after the RSVPreF3 OA dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group)
RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dilution 60 (ED60).
次要结局
- RSV-A Neutralization Antibody 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))
- HI Seroprotection Rate (SPR) for 4 FLU Vaccine Strains(At Day 1 (Baseline) and Day 31)
- HI Antibody Titers for 4 FLU Vaccine Strains Expressed as MGI(At 1 month after the FLU dose (Day 31 for both groups) compared to pre-vaccination (Day 1 for both groups))
- Percentage of Participants Reporting Each Solicited Administration Site Event After Each Vaccine Dose Administration(Within 7 days (the day of vaccination and 6 subsequent days) after each vaccine administration (vaccines administered at Day 1 for CoAd Group and at Day 1 and Day 31 for Control group))
- HI Seroconversion Rate (SCR) for 4 FLU Vaccine Strains(At 1 month after the FLU vaccine dose (Day 31 for both groups))
- RSV-B Neutralization Antibody 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))
- Titers for HI Antibodies Against 4 FLU Vaccine Strains(At Day 1 (Baseline) and Day 31)
- Percentage of Participants Reporting Each Solicited Systemic Event After Each Dose Administration(Within 7 days (the day of vaccination and 6 subsequent days) after each vaccine administration (vaccines administered at Day 1 and Day 31 for C-oAd Group and at Day 1 and Day 31 for Control group))
- Percentage of Participants Reporting at Least One Potential Immune-mediated Disease (pIMDs)(From Day 1 until 6 months after last vaccination (Month 6 for the Co-Ad Group, Month 7 for the Control group))
- Percentage of Participants Reporting Unsolicited Adverse Events (AEs)(Within 30 days (the day of vaccination and 29 subsequent days) after each vaccine administration)
- Percentage of Participants Reporting at Least One Serious Adverse Event (SAEs)(From Day 1 until 6 months after last vaccination (Month 6 for the Co-Ad Group, Month 7 for the Control group))
研究者
研究点 (1)
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