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

NCT ID: NCT00240877

Last Updated: 2008-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Study Completion Date

2004-04-30

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.

Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Monovalent vaccine prior to the release of the trivalent vaccine (FluMist).

Group Type EXPERIMENTAL

AV024

Intervention Type BIOLOGICAL

0.5 mL total dose volume administered intranasal by spray applicator (approximately 0.25 mL into each nostril).

2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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).

Interventions

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AV024

0.5 mL total dose volume administered intranasal by spray applicator (approximately 0.25 mL into each nostril).

Intervention Type BIOLOGICAL

Placebo

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).

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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MedImmune LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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MedImmune Inc.

Principal Investigators

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Robert Walker, MD

Role: STUDY_DIRECTOR

MedImmune LLC

Locations

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SFBC International Inc

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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AV024

Identifier Type: -

Identifier Source: org_study_id