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
- 301
- 试验地点
- 4
- 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 2016-2017 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. Eligible subjects 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 3 sites in the United States of America. Each subject will receive 1 dose of investigational product on Day 1. The duration of study participation for each subject 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)
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
- •Subject 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 prior to randomization
- •Any known immunosuppressive condition or immune deficiency disease, including human immunodeficiency virus infection, or ongoing immunosuppressive therapy
- •History of Guillain-Barré syndrome
研究组 & 干预措施
Placebo
A single dose of placebo matched to monovalent influenza vaccine will be administered as intranasal spray on Day 1.
干预措施: Placebo (Other)
Monovalent Influenza Vaccine
A single dose of 10^(7.0 +/- 0.5) fluorescent focus units (FFU) strain of monovalent influenza vaccine will be administered as intranasal spray on Day 1.
干预措施: Monovalent Influenza Vaccine (Biological)
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 Who Require Antipyretic and/or Analgesic Medication(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)
- Percentage of Participants With Solicited Symptoms(Baseline (Day 1) up to Day 8 and Day 15)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)(Baseline (Day 1) up to Day 8 and Day 15)