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

Influenza Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00240877
• Other study ID #: AV024
• Status: Completed
• Phase: Phase 3
• First received: October 14, 2005
• Last updated: November 19, 2008
• Start date: August 2002
• Est. completion date: April 2004

Study information

• Verified date: November 2008
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: April 2004
• Est. primary completion date: August 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza

Intervention

Biological:
• AV024
0.5 mL total dose volume administered intranasal by spray applicator (approximately 0.25 mL into each nostril).

Other:
• 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).

Locations

Country	Name	City	State
United States	SFBC International Inc	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
MedImmune LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- The primary endpoint of this study is fever defined as oral temperature =101°F		Days 0-7
Secondary	All other reported reactogenicity events and other adverse events.		After 7 days after vaccination	Yes