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

Basic Information

• 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

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

Detailed Description

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

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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

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

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

MedImmune LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

MedImmune Inc.

Principal Investigators

Robert Walker, MD

Role: STUDY_DIRECTOR

MedImmune LLC

Locations

SFBC International Inc

Miami, Florida, United States

Countries

United States

Other Identifiers

AV024

Identifier Type: -

Identifier Source: org_study_id