2023-510196-59-00已完成3 期
A Phase 3, open-label, randomized, controlled study to evaluate the immune response, safety and reactogenicity of RSVPreF3 OA investigational vaccine when co-administered with a COVID-19 mRNA vaccine (Omicron XBB.1.5) in adults aged 50 years and above.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 16
- 主要终点
- • RSV-A neutralization titers expressed as group GMT ratio 1 month after the RSVPreF3 OA investigational vaccine dose. • RSV-B neutralization titers expressed as group GMT ratio 1 month after the RSVPreF3 OA investigational vaccine dose.
研究概览
简要总结
• To demonstrate non-inferiority of humoral immune response to RSVPreF3 OA investigational vaccine when co-administered with a COVID 19 mRNA vaccine compared to RSVPreF3 OA investigational vaccine administered alone. • To demonstrate non-inferiority of humoral immune response to a COVID-19 mRNA vaccine when co-administered with the RSVPreF3 OA investigational vaccine compared to COVID-19 mRNA vaccine administered alone.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 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 diary cards, return for follow-up visits). INC#1
- •Written or witnessed informed consent obtained from the participant (participant must be able to understand the informed consent) prior to performance of any study-specific procedure. INC#2
- •A male/female of ≥50 YOA at the time of the first study intervention administration. INC#3
- •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. INC#4
- •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. INC#5
- •Participants who have received previously a SARS-CoV-2 vaccine, being administered at least 3 months prior to study vaccination. INC#6
- •Female participants of non-childbearing potential may be enrolled in the study. Non childbearing potential is defined as hysterectomy, bilateral oophorectomy, bilateral salpingectomy, and post-menopause. INC#7
- •"Female participants of childbearing potential may be enrolled in the study if the participant. INC#8 has practiced adequate contraception from 1 month prior to study intervention administration and agreed to continue adequate contraception for at least 1 month after the last vaccination. has a negative pregnancy test on the day of and prior to study intervention administration. "
排除标准
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions, including a known history of severe allergic reaction (e.g., anaphylaxis). EXC#1
- •Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study. EXC#10
- •Recent SARS-CoV-2 infection within 3 months prior to the COVID-19 vaccine dose administration. Timelines to be determined from symptoms onset or positive COVID-19 test (if infection was asymptomatic). EXC#11
- •Use of any investigational or non-registered product (drug, vaccine or invasive medical device) other than the study interventions during the period beginning 30 days before the first dose of study interventions and ending 30 days after the last vaccine administration, or their planned use during the study period. EXC#12
- •Planned administration of a vaccine in the period starting 30 days before the first dose and ending 30 days after the last dose of study intervention(s) administration*, with the exception of inactivated and subunit influenza vaccines which can be administered up to 14 days before or from 14 days after the study vaccination. EXC#13
- •"• Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune-modifying treatments at any time up to the last blood sampling visit. EXC#14 Up to 3 months prior to the study intervention administration: o For corticosteroids, this will mean prednisone equivalent ≥ 20 mg/day. Inhaled and topical steroids are allowed. o Administration of immunoglobulins and/or any blood products or plasma derivatives. Up to 6 months prior to study intervention administration: long-acting immune modifying drugs including among others immunotherapy (e.g., TNF-inhibitors), monoclonal antibodies and antitumoral medication."
- •Administration of any SARS-CoV-2 vaccine during the 3 months preceding the study COVID-19 mRNA vaccine administration. EXC#15
- •Previous vaccination with licensed or investigational RSV vaccine. EXC#16
- •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). EXC#17
- •Pregnant or lactating female participant. EXC#18
- •Female participant planning to become pregnant or planning to discontinue contraceptive precautions. EXC#19
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, resulting from disease (e.g., current malignancy, human immunodeficiency virus) or immunosuppressive/cytotoxic therapy (e.g., medication used during cancer chemotherapy, organ transplantation, or to treat autoimmune disorders), based on medical history and physical examination (no laboratory testing required). EXC#2
- •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. EXC#20
- •Participation of any study personnel or their immediate dependents, family, or household members. EXC#21
- •Planned move during the study conduct that prohibits participation until study end. EXC#22
- •Bedridden participants. EXC#23
- •Any history of myocarditis or pericarditis. EXC#3
- •Recurrent history 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 (e.g. completion of diary cards, attend regular phone calls/study site visits). EXC#4
- •Serious or unstable chronic illness. EXC#5
- •Any history of dementia or any medical condition that moderately or severely impairs cognition. EXC#6
- •Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study (e.g., life-threatening disease likely to limit survival up to study end). EXC#7
- •Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe. EXC#8
- •Any SAE attributed to a previous dose of the SARS-CoV-2 mRNA vaccine. EXC#9
结局指标
主要结局
• RSV-A neutralization titers expressed as group GMT ratio 1 month after the RSVPreF3 OA investigational vaccine dose. • RSV-B neutralization titers expressed as group GMT ratio 1 month after the RSVPreF3 OA investigational vaccine dose.
• RSV-A neutralization titers expressed as group GMT ratio 1 month after the RSVPreF3 OA investigational vaccine dose. • RSV-B neutralization titers expressed as group GMT ratio 1 month after the RSVPreF3 OA investigational vaccine dose.
• SARS-CoV-2 Omicron XBB.1.5 neutralization titers against pseudovirus bearing S protein expressed as group GMT ratio 1 month after the COVID-19 mRNA vaccine.
• SARS-CoV-2 Omicron XBB.1.5 neutralization titers against pseudovirus bearing S protein expressed as group GMT ratio 1 month after the COVID-19 mRNA vaccine.
次要结局
- • RSV-A and RSV-B neutralization titers expressed as GMT, MGI and SRR at 1 month after the RSVPreF3 OA investigational vaccine dose. • Percentage of participants having RSV-A and RSV-B neutralizing titers ≥ assay cut-off (i.e., LLOQ) at pre-vaccination and 1 month after the RSVPreF3 OA investigational vaccine dose.
- "• SARS-CoV-2 Omicron XBB.1.5 neutralization titers against pseudovirus bearing S protein expressed as GMT and MGI at 1 month after the COVID-19 mRNA vaccine. • Percentage of participants having SARS-CoV-2 Omicron XBB.1.5 neutralization titers ≥ assay cut-off (i.e., LLOQ) at pre-vaccination and 1 month after the COVID-19 mRNA vaccine dose."
- "• Percentage of participants reporting each solicited administration site event and systemic event within 4 days post study intervention administration (i.e., the day of vaccination and 3 subsequent days). • Percentage of participants reporting unsolicited AEs within 30 days post study intervention administration (i.e., the day of vaccination and 29 subsequent days)."
- "• Percentage of participants reporting SAEs after study intervention administration (Day 1) up to study end (6 months after last study intervention administration). • Percentage of participants reporting pIMDs after study intervention administration (Day 1) up to study end (6 months after last study intervention administration). "
研究者
EU GSK Clinical Trials Call Center
Scientific
GlaxoSmithKline Biologicals
研究点 (16)
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