CTRI/2024/09/073941已完成3 期
A Phase 3 randomized, placebo-controlled observer blind study in India to evaluate immune response reactogenicity and safety of a single intramuscular dose of RSVPreF3 OA investigational vaccine when administered to older adults ≥60 years of age and adults 50‑59 years of age at increased risk of respiratory syncytial virus lower respiratory tract disease.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 750
- 试验地点
- 15
- 主要终点
- To evaluate the humoral immune response following
研究概览
简要总结
The purpose of the current study is to evaluate the immunogenicity and safety of a single
dose of investigational RSVPreF3 OA vaccine in Indian older adults ≥60 YOA and Indian adults 50-59 YOA at increased risk of RSV-LRTD.
RSV is a ribonucleic acid virus of the Pneumoviridae family that causes ARI in humans. There are 2 subtypes of RSV - RSV A and RSV B - circulating with
other respiratory viruses. Overall, the peak activity of RSV mainly occurs during the rainy season and winter period in India, and some correlation with low temperatures has been observed. RSV causes upper and lower respiratory tract infections in people of all ages with the risk of serious infection increasing in young
children, OA and adults at high-risk due to presence of comorbidities.
Currently there is no treatment option or licensed vaccine in India for the prevention of RSV related LRTD in adults
GSK has developed a vaccine (RSVPreF3 OA) that will protect against RSV associated LRTD in adults 60 years of age (YOA) or older and 50-59 years of age who are at increased risk for RSV disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 50.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary, return for follow-up visits, ability to access and utilize a phone or other electronic communications).
- •2.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 Specific inclusion criteria for all participants in Cohort 1 (Older adults) 3.Male or female, ≥ 60 YOA at the time of the study intervention administration.
- •4.Participants who are medically stable in the opinion of the investigator at the time of study intervention administration.
- •Participants with chronic stable medical conditions with or without specific treatment, such as diabetes mellitus, hypertension, or cardiac disease, are allowed to participate in this study if considered by the investigator as medically stable.
- •5.Participants living in the general community or in an assisted-living facility that provides minimal assistance can be enrolled, such that the participant is primarily responsible for self-care and activities of daily living.
- •Specific inclusion criteria for all participants in Cohort 2 (Adults-AIR) 6.Male or female, 50-59 YOA at the time of the study intervention administration.
- •Participants should be diagnosed with at least 1 of the following medical conditions and considered medically stable by the investigator: Chronic pulmonary disease resulting in activity restricting symptoms or use of long-term medication Chronic cardiovascular disease Pre-existing coronary artery disease (CAD not otherwise specified) Cardiac arrhythmia Diabetes mellitus: type 1 or type 2 with active treatment for the last 6 months Other diseases at increased risk for RSV-LRTD disease 8.Female participants of non-childbearing potential may be enrolled in the study.
- •Non-childbearing potential is defined as hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or post-menopause.
- •9.Female participants of childbearing potential may be enrolled in the study if the participant − has practiced adequate contraception from 1 month prior to study intervention administration, and − has a negative pregnancy test on the day of and prior to study intervention administration, and − has agreed to continue adequate contraception for at least 1 month after the study intervention administration.
排除标准
- •1.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).
- •2.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).
- •3.Unstable chronic illness.
- •4.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 the eDiary, attend phone call/study site visits).
- •5.Any history of dementia or any medical condition that moderately or severely impairs cognition.
- •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).
- •7.Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
- •8.Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
- •9.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 (Day -29 to Day 1) before the dose of study interventions or their planned use during the study period (Day 1 up to Month 6).
- •10.Previous vaccination with licensed or investigational RSV vaccine.
- •11.Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after the dose of study intervention administration, with the exception of inactivated, subunit and split influenza vaccines or COVID-19 vaccines (fully licensed or with emergency use authorization [EUA]) which can be administered up to 14 days before or from 14 days after the study intervention administration.
- •12.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 end of the study.
- •13.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).
- •14.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.
- •15.Participation of any study personnel or their immediate dependents, family, or household members.
- •16.Planned move during the study conduct that prohibits participation until study end.
- •17.Bedridden participants.
- •18.Pregnant or lactating female participant.
- •19.Female participant planning to become pregnant or planning to discontinue contraceptive precautions.
结局指标
主要结局
To evaluate the humoral immune response following
时间窗: RSV-A and RSV-B neutralizing titers pre-study | intervention administration and at 1 month after | study intervention administration.
administration of a single dose of the RSVPreF3 OA
时间窗: RSV-A and RSV-B neutralizing titers pre-study | intervention administration and at 1 month after | study intervention administration.
investigational vaccine.
时间窗: RSV-A and RSV-B neutralizing titers pre-study | intervention administration and at 1 month after | study intervention administration.
次要结局
- To evaluate the safety and reactogenicity following(administration of a single dose of the RSVPreF3 OA)
研究者
Dr. Yashpal Chugh
GSK Pharma India Private Limited
研究点 (15)
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