A Phase 4 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety of 1 New 6:2 Influenza Virus Reassortant in Adults
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Percentage of Participants With Fever Greater Than or Equal to (>=) 101 Degrees Fahrenheit (F)
研究概览
简要总结
This prospective annual release study is designed to evaluate the safety of 1 new influenza virus vaccine strain to be included in FluMist Quadrivalent for the 2017-2018 influenza season.
详细描述
This prospective, randomized, double-blind, placebo-controlled release study will enroll approximately 300 healthy adults 18 to 49 years of age (not yet reached their 50th birthday). Eligible participants will be randomly assigned in a 4:1 fashion to receive a single dose of monovalent vaccine or placebo by intranasal spray. Randomization will be stratified by site. This study will be conducted at 2 sites in the United States of America. Each participant will receive 1 dose of investigational product on Day 1. The duration of study participation for each participant is the time from study vaccination through 180 days after study vaccination.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 through 49 years
- •Written informed consent
- •Participant available by telephone
- •Ability to understand and comply with the requirements of the protocol, as judged by the Investigator
排除标准
- •Concurrent enrollment in another clinical study up to 180 days after receipt of investigational product (Day 181)
- •History of hypersensitivity to any component of the vaccine, including egg or egg protein or serious, life threatening, or severe reactions to previous influenza vaccinations
- •Any condition for which the inactivated influenza vaccine is indicated, including chronic disorders of the pulmonary or cardiovascular systems (example [eg], asthma), chronic metabolic diseases (eg, diabetes mellitus), renal dysfunction, or hemoglobinopathies that required regular medical follow-up or hospitalization during the preceding year
- •Acute febrile (greater than [>] 100.0 degrees Fahrenheit [F] oral or equivalent) and/or clinically significant respiratory illness (example, cough or sore throat) within 14 days to randomization
- •Any known immunosuppressive condition or immune deficiency diseases, including human immunodeficiency virus infection, or ongoing immunosuppressive therapy
- •History of Guillain-Barre syndrome
- •Receipt of any investigational agent within 30 days prior to randomization, or expected receipt through 30 days after the dose of investigational product (use of licensed agents for indications not listed in the Package Insert is permitted)
- •Receipt of any non-study vaccine within 30 days prior to randomization, or expected receipt through 30 days after receipt of investigational product
- •Expected receipt of antipyretic or analgesic medication on a daily or every other day basis from randomization through 14 days after receipt of investigational product
- •Administration of intranasal medications within 14 days prior to randomization, or expected receipt through 14 days after administration of investigational product
- •Receipt of influenza antiviral therapy or influenza antiviral agents within 48 hours prior to investigational product administration or expected receipt of influenza antiviral therapy or influenza antiviral agents through 14 days after receipt of investigational product
研究组 & 干预措施
Monovalent Influenza Vaccine
Participants will receive a single dose of monovalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 1 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strain] by intranasal spray on Day 1.
干预措施: Monovalent Influenza Vaccine (Biological)
Placebo
Participants will receive a single dose of placebo matching with monovalent influenza vaccine by intranasal spray on Day 1.
干预措施: Placebo (Other)
结局指标
主要结局
Percentage of Participants With Fever Greater Than or Equal to (>=) 101 Degrees Fahrenheit (F)
时间窗: Baseline (Day 1) up to Day 8
Percentage of participants with fever defined as oral temperature \>=101 degrees F were reported.
次要结局
- Percentage of Participants With Solicited Symptoms(Baseline (Day 1) up to Day 8 and Day 15)
- Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and New Onset Chronic Diseases (NOCDs)(Baseline (Day 1) up to Day 29 and Day 181)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)(Baseline (Day 1) up to Day 8 and Day 15)
- Percentage of Participants Who Require Antipyretic and/or Analgesic Medication(Baseline (Day 1) up to Day 8 and Day 15)