Study to Evaluate the Safety of a Monovalent Vaccine of a New 6:2 Reassortant in Healthy Adults (AV024)

Study Overview
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Brief Summary
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To assess the safety of a vaccine in healthy adults prior to the release of the trivalent vaccine (FluMist).

Detailed Description
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The primary study objective is to assess the safety of a monovalent vaccine of a new 6:2 reassortant in healthy adults prior to the release of the trivalent vaccine (FluMist). Safety will be demonstrated by similar fever rates (oral temperature ≥101°F) in vaccine and placebo recipients.

Official Title
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A Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of a Monovalent Vaccine of a New 6:2 Reassortant in Healthy Adults (AV024)

Conditions
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Influenza

Intervention / Treatment
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* Biological: AV024
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-64 years of age (not yet reached their 65th birthday); In good health; Available by telephone; Ability to understand and comply with the requirements of the protocol; and Signed informed consent. Exclusion Criteria: Any condition, other than age, for which the inactivated influenza vaccine is indicated, including: chronic disorders of the pulmonary or cardiovascular systems, including asthma; chronic metabolic diseases (including diabetes mellitus) renal dysfunction, or hemoglobinopathies which required regular medical follow-up or hospitalization during the proceeding year; Acute febrile (>100.0°F oral) illness or clinically significant respiratory illness within the 14 days prior to enrollment; Hypersensitivity to egg or egg protein; Signs or symptoms of any immunosuppressive or immune deficiency disease, including HIV infection, or ongoing immunosuppressive therapy; or an immunosuppressed individual living in the same household; Participation in another investigational trial within one month prior to enrollment or expected enrollment in another investigational trial during this study; and Any condition that in the opinion of the investigator, might interfere with the vaccine evaluation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Monovalent vaccine prior to the release of the trivalent vaccine (FluMist). | Biological: AV024<br>* 0.5 mL total dose volume administered intranasal by spray applicator (approximately 0.25 mL into each nostril).<br>|
| Placebo Comparator: 2<br>Placebo | Other: Placebo<br>* Placebo mist consisting of normal allantoic fluid. 0.5 mL total dose volume administered intranasal by spray applicator (approximately 0.25 mL into each nostril).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - The primary endpoint of this study is fever defined as oral temperature ≥101°F |  | Days 0-7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All other reported reactogenicity events and other adverse events. |  | After 7 days after vaccination |