A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase Ⅲ Trial on the Efficacy, Safety and Immunogenicity of Live-Attenuated Influenza Vaccine (LAIV)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 9,000
- 试验地点
- 3
- 主要终点
- Percentage of Subjects With Symptomatic, Laboratory-confirmed(RT-PCR/ Virus Culture) Influenza Virus Infection(Vaccine-like Strains)
研究概览
简要总结
This study is a Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase Ⅲ Trial to evaluate the efficacy, safety and immunogenicity of a single dose of Live-Attenuated influenza Vaccine(LAIV) among healthy children and adolescents aged 3-17 years.
详细描述
This study is a Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase Ⅲ Trial to evaluate the efficacy, safety and immunogenicity of a single dose of Live-Attenuated influenza Vaccine(LAIV) among healthy children and adolescents aged 3-17 years old. The subjects will be randomized in a 1:1 ratio of LAIV to placebo. Each subject will be vaccinated with a single dose of LAIV or Placebo. For evaluation of efficacy, subjects meeting the protocol-defined clinical case definition the 14th day post-vaccination will have a nasal swab collected for testing by RT-PCR or virus culture for evidence of influenza virus infection. All adverse events will be collected 30 minutes, 0-30 days after vaccination and all serious adverse events during the entire trial period. Blood samples will be collected from a part of subjects before vaccination and at the 30th day after immunization. Serum samples will be centrifuged for detection of antibodies to H1N1, H3N2, and influenza B.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children and adolescents aged 3-17 years old.
- •Informed consent obtained and signed by subjects or legal guardians prior to screening. Children or adolescents aged 10-17 yrs need sign informed consent by themselves.
- •Willing to participate for the planned duration of the study, including availability for follow-up.
排除标准
- •Any investigational or unregistered product (drug, vaccine or device) was used within 30 days, or planned to be used during the trial.
- •have been vaccinated with any influenza vaccine within 6 months, or plan to be vaccinated during the trail.
- •Immunosuppressive agents or other immunomodulatory drugs (defined as continuous use for more than 14 days) were used over a 3-month period.
- •Immunoglobulins and / or any blood products were used within 3 months, or planned to be used before blood collection.
- •History of Guillain-Barré syndrome; History of hypersensitivity to any component of the LAIV, including egg or egg products.
- •Severe allergic reactions after vaccination (including anaphylactic shock, allergic laryngeal edema, allergic purpura, local allergic necrosis).
- •Acute diseases , infections or febrile diseases (axillary temperature ≥37.1℃) on the day of vaccination.
- •Obvious coagulation dysfunction or History of anticoagulant therapy
- •Aspirin is being used(Salicylates are a potential risk factor for Reye syndrome)
- •Known or suspected immune deficiency diseases or immunosuppressed
- •Heart disease, respiratory diseases (including severe rhinitis, nasal deformities, polyps, etc.), liver disease, kidney disease, mental disorders, chronic infections etc.
研究组 & 干预措施
Placebo
a single dose of Placebo. Inactivated placebo will be identical to LAIV in appearance, ingredients and concentrations, attenuated influenza virus free.
干预措施: Placebo (Biological)
LAIV
a single dose of Live-Attenuated influenza Vaccine;Dose: 0.2 ml; Each dose contains not less than 6.9 lg EID50 of type A live attenuated influenza virus reassortants(H1N1 and H3N2), and not less than 6.4 lg EID50 of type B live attenuated influenza virus reassortants.
干预措施: Live-Attenuated influenza Vaccine(LAIV) (Biological)
结局指标
主要结局
Percentage of Subjects With Symptomatic, Laboratory-confirmed(RT-PCR/ Virus Culture) Influenza Virus Infection(Vaccine-like Strains)
时间窗: Through 2 weeks to 1 year post vaccination
次要结局
- Geometric Mean Titers (GMT) of Hemagglutination Inhibition (HAI) Antibodies to each of the Influenza Strains in the Vaccine Received(30 days post vaccination)
- Percentage of Subjects With Symptomatic, Laboratory-confirmed(RT-PCR/ Virus Culture) Influenza Virus Infection(Regardless of Vaccine Match)(Through 2 weeks to 1 year post vaccination)
- Percentage of Subjects with influenza-like illness caused by Influenza Virus Infection(Laboratory-confirmed by RT-PCR/ Virus Culture)(Through 2 weeks to 1 year post vaccination)
- Percentage of subjects with antibody positive conversion to each of the Influenza Strains in the Vaccine Received.(30 days post vaccination)
- Adverse Events Occurring Within 30 Minutes of Administration of Study Vaccine(Through 30 minutes post vaccination)
- Solicited Adverse Events(Through 14 days post vaccination)
- Unsolicited Adverse Events(Through 30 days post vaccination)
- Serious Adverse Events(Through 1 year post vaccination)