CTRI/2025/10/095731招募中2/3 期
A Phase II/III, Multicentre, Observer-Blind, Randomized, Active-Controlled Study to Evaluate Immunogenicity and Safety of A Trivalent Nanoparticle Influenza Vaccine and Covid-Influenza Combination Vaccine Compared with Licensed Influenza and COVID -19 Vaccines in Adults
Serum Institute of India Private Limited (SIIPL)20 个研究点 分布在 1 个国家目标入组 2,400 人开始时间: 2025年10月27日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 2,400
- 试验地点
- 20
- 主要终点
- HAI Seroconversion for all 3 influenza strains at Day 29 post vaccination
研究概览
简要总结
This is a phase 2/3 randomized, double blind, active control, multi-center clinical study to evaluate immunogenicity and safety of trivalent nanoparticle influenza vaccine and covid-influenza combined vaccine compared with licensed influenza and covid vaccine in adults
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult Male or female participants
- •Participants must be healthy / clinically stable.
- •Willing to adhere to the protocol requirements and to provide informed consent.
- •Intend to remain residing in study area during study period.
- •History of having completed primary vaccination against SARS-CoV-2
- •Female participants of childbearing potential having a negative urine pregnancy test and agreeing to practice adequate contraception during specific study period.
排除标准
- •Fever or any clinically significant acute infection
- •Respiratory symptoms
- •A known hypersensitivity to any of the vaccine components
- •History of myocarditis or pericarditis, Guillain-Barré Syndrome (GBS), any prior motor neuropathy, receipt of any influenza vaccine.
- •Laboratory-confirmed COVID-19, asymptomatic SARS-CoV-2 infection, or influenza.
- •Known or suspected congenital or acquired immunodeficiency
- •History of chronic administration of immunosuppressant or other immune modifying drugs preceding study vaccination.
- •Presence of any uncontrolled systemic disorder
- •Receipt of any blood products, COVID-19 monoclonal antibodies or antibody cocktails
- •Participation in a clinical trial
- •Lactating or pregnant women.
- •History or presence of alcoholism or drug abuse.
- •Any other condition which in the opinion of the investigator will jeopardize the safety or rights of the participant.
结局指标
主要结局
HAI Seroconversion for all 3 influenza strains at Day 29 post vaccination
时间窗: baseline and day 29 post vaccination
HAI titer for all 3 influenza strains at Day 29 post-vaccination
时间窗: baseline and day 29 post vaccination
nAbs assessed by MN assay using vaccine homologous virus (Omicron variant JN.1 strain) at Day 29
时间窗: baseline and day 29 post vaccination
次要结局
- Immediate adverse events within 30 (+15) minutes of study(vaccination)
研究者
研究点 (20)
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