A Phase 4, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Safety of 2 New of 6:2 Influenza Virus Reassortants 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 Reporting Fever (Oral Temperature >= 101 Degrees Fahrenheit) Through Day 8
研究概览
简要总结
This prospective annual release study is designed to evaluate the safety of 2 new influenza virus vaccine strains to be included in FluMist Quadrivalent for the 2018-2019 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 subjects will be randomly assigned in a 4:1 fashion to receive a single dose of bivalent 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 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), renaldysfunction, 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.
结局指标
主要结局
Percentage of Participants Reporting Fever (Oral Temperature >= 101 Degrees Fahrenheit) Through Day 8
时间窗: Day 1 through Day 8
Percentage of participants with fever (oral temperature \>= 101 degrees Fahrenheit) through Day 8 is reported.
次要结局
- Number of Participants With Solicited Symptoms Through Day 8(Day 1 through Day 8)
- Number of Participants With Solicited Symptoms Through Day 15(Day 1 through Day 15)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) Through Day 8 and Day 15(Day 1 through Day 8; Day 1 through Day 15)
- Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) Through Day 29 and Day 181(Day 1 through Day 29; Day 1 through Day 181)
- Number of Participants With New Onset Chronic Diseases (NOCDs) Through Day 29 and Day 181(Day 1 through Day 29; Day 1 through Day 181)