Clinical trial NCT03564444: D2560C00015 FluMist Annual Safety Study 2018
Official title: A Phase 4, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Safety of 2 New of 6:2 Influenza Virus Reassortants in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Healthy
Keywords: Bivalent.
Influenza.
FluMist Quadrivalent.
Vaccine Prevention in Healthy Adults.
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2018-06-20
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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Reporting Fever (Oral Temperature >= 101 Degrees Fahrenheit) Through Day 8
timeFrame: Day 1 through Day 8
Secondary outcomes:
measure: Number of Participants With Solicited Symptoms Through Day 8
timeFrame: Day 1 through Day 8
measure: Number of Participants With Solicited Symptoms Through Day 15
timeFrame: Day 1 through Day 15
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Through Day 8 and Day 15
timeFrame: Day 1 through Day 8; Day 1 through Day 15
measure: Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) Through Day 29 and Day 181
timeFrame: Day 1 through Day 29; Day 1 through Day 181
measure: Number of Participants With New Onset Chronic Diseases (NOCDs) Through Day 29 and Day 181
timeFrame: Day 1 through Day 29; Day 1 through Day 181
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:
affiliation: Clinical Research Atlanta
name: Nathan Segall, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia Research Group
name: Keith Klatt, MD
role: PRINCIPAL_INVESTIGATOR
References: