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

Phase 3

Completed

• Conditions: Influenza
• Interventions: Biological: AV024; Other: Placebo

• Registration Number: NCT00240877
• Lead Sponsor: MedImmune LLC

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.

Study Timeline

• Study Start: 2002-08
• Primary Completion: 2003-08
• Study Completion: 2004-04
• Study First Submitted: 2005-10-14
• Study First Submitted QC: 2005-10-14
• Study First Posted: 2005-10-18
• Status Verified: 2008-11
• Last Update Submitted: 2008-11-19
• Last Update Posted: 2008-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AV024	Monovalent vaccine prior to the release of the trivalent vaccine (FluMist).
2	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
- The primary endpoint of this study is fever defined as oral temperature ≥101°F	Days 0-7

Secondary Outcome Measures

Name	Time	Method
All other reported reactogenicity events and other adverse events.	After 7 days after vaccination

Trial Locations

Locations (1)

SFBC International Inc; 🇺🇸 Miami, Florida, United States