D2560C00015 FluMist Annual Safety Study 2018

Phase 4

Completed

Conditions: Influenza
Healthy

Interventions: Biological: Bivalent influenza vaccine
Other: Placebo

Registration Number: NCT03564444

Lead Sponsor: MedImmune LLC

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 300

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bivalent influenza vaccine	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
Placebo	Placebo	A single dose of placebo matched to bivalent influenza vaccine will be administered as intranasal spray on Day 1.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Reporting Fever (Oral Temperature >= 101 Degrees Fahrenheit) Through Day 8	Day 1 through Day 8	Percentage of participants with fever (oral temperature \>= 101 degrees Fahrenheit) through Day 8 is reported.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Solicited Symptoms Through Day 8	Day 1 through Day 8	For this study, solicited symptoms included oral fever (\> 100 degrees Fahrenheit), runny nose, sore throat, cough, vomiting, muscle aches, chills, decreased activity (tiredness), and headache.
Number of Participants With Solicited Symptoms Through Day 15	Day 1 through Day 15	For this study, solicited symptoms included oral fever (\> 100 degrees Fahrenheit), runny nose, sore throat, cough, vomiting, muscle aches, chills, decreased activity (tiredness), and headache.
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	An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
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	An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
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	An NOCD is a newly diagnosed medical condition that is of a chronic, ongoing nature and is assessed by the investigator as medically significant.