A Phase 4 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety of 1 New 6:2 Influenza Virus Reassortant in Adults
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- MedImmune LLC
- Enrollment
- 301
- Locations
- 3
- Primary Endpoint
- Percentage of Participants With Fever Greater Than or Equal to (>=) 101 Degrees Fahrenheit (F)
Study Overview
Brief Summary
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
Detailed Description
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.
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), 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
Arms & Interventions
Placebo
A single dose of placebo matched to monovalent influenza vaccine will be administered as intranasal spray on Day 1.
Intervention: 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.
Intervention: Monovalent Influenza Vaccine (Biological)
Outcomes
Primary Outcomes
Percentage of Participants With Fever Greater Than or Equal to (>=) 101 Degrees Fahrenheit (F)
Time Frame: Baseline (Day 1) up to Day 8
Percentage of participants with fever defined as oral temperature \>=101 degrees F were reported.
Secondary Outcomes
- 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 Who Require Antipyretic and/or Analgesic Medication(Baseline (Day 1) up to Day 8 and Day 15)
- 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)