A Phase 4, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Safety of 2 New of 6:2 Influenza Virus Reassortants in Adults
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- MedImmune LLC
- Enrollment
- 300
- Locations
- 2
- Primary Endpoint
- Percentage of Participants Reporting Fever (Oral Temperature >= 101 Degrees Fahrenheit) Through Day 8
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 49 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Arms & Interventions
Bivalent influenza vaccine
A single dose of bivalent vaccine (10^7±5 fluorescent focus unit of 2 cold-adapted, attenuated, temperature-sensitive, 6:2 reassortant influenza strain) will be administered as intranasal spray on Day 1
Intervention: Bivalent influenza vaccine (Biological)
Placebo
A single dose of placebo matched to bivalent influenza vaccine will be administered as intranasal spray on Day 1.
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Percentage of Participants Reporting Fever (Oral Temperature >= 101 Degrees Fahrenheit) Through Day 8
Time Frame: Day 1 through Day 8
Percentage of participants with fever (oral temperature \>= 101 degrees Fahrenheit) through Day 8 is reported.
Secondary Outcomes
- 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)