D2560C00015 FluMist Annual Safety Study 2018

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase 4, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Safety of 2 New of 6:2 Influenza Virus Reassortants in Adults

Conditions
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Influenza, Healthy

Intervention / Treatment
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* Biological: Bivalent influenza vaccine
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bivalent influenza vaccine<br>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 | Biological: Bivalent influenza vaccine<br>* 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.<br>|
| Placebo Comparator: Placebo<br>A single dose of placebo matched to bivalent influenza vaccine will be administered as intranasal spray on Day 1. | Other: Placebo<br>* A single dose of placebo matched to bivalent influenza vaccine will be administered as intranasal spray on Day 1.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Reporting Fever (Oral Temperature >= 101 Degrees Fahrenheit) Through Day 8 | Percentage of participants with fever (oral temperature >= 101 degrees Fahrenheit) through Day 8 is reported. | Day 1 through Day 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Solicited Symptoms 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. | Day 1 through Day 8 | 
| Number of Participants With Solicited Symptoms 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. | Day 1 through Day 15 | 
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) Through Day 8 and 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. | 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 | 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. | 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 | An NOCD is a newly diagnosed medical condition that is of a chronic, ongoing nature and is assessed by the investigator as medically significant. | Day 1 through Day 29; Day 1 through Day 181 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bivalent., Influenza., FluMist Quadrivalent., Vaccine Prevention in Healthy Adults.