Clinical trial NCT03158038: Study to Evaluate the Safety of 1 New 6:2 Influenza Virus Reassortant in Adults for the 2017-2018 Season
Official title: A Phase 4 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety of 1 New 6:2 Influenza Virus Reassortant in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Healthy
Keywords: Trivalent
Influenza
FluMist Quadrivalent
Vaccine
Prevention
Healthy
Monovalent
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
Collaborators: name: AstraZeneca
First posted: 2017-05-17
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 2017-2018 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 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.

Eligibility criteria: Key Inclusion Criteria:

* 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

Key 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 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

Primary outcomes:
measure: Percentage of Participants With Fever Greater Than or Equal to (>=) 101 Degrees Fahrenheit (F)
timeFrame: Baseline (Day 1) up to Day 8
Secondary outcomes:
measure: Percentage of Participants With Solicited Symptoms
timeFrame: Baseline (Day 1) up to Day 8 and Day 15
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Baseline (Day 1) up to Day 8 and Day 15
measure: Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and New Onset Chronic Diseases (NOCDs)
timeFrame: Baseline (Day 1) up to Day 29 and Day 181
measure: Percentage of Participants Who Require Antipyretic and/or Analgesic Medication
timeFrame: Baseline (Day 1) up to Day 8 and Day 15
Other outcomes:
Locations:
city: Stockbridge
country: United States
facility: Research Site
state: Georgia
city: Portland
country: United States
facility: Research Site
state: Oregon
Study officials:
References: