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

NCT00240877 | Completed Phase 3

• 1 other identifier: AV024
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

• - The primary endpoint of this study is fever defined as oral temperature ≥101°F

  Days 0-7

Secondary Outcomes (1)

• All other reported reactogenicity events and other adverse events.

  After 7 days after vaccination

Study Arms (2)

1

EXPERIMENTAL

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

Biological: AV024

2

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

AV024 BIOLOGICAL

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

1

Placebo 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).

2

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (1)

SFBC International Inc

Miami, Florida, 33181, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Robert Walker, MD

  MedImmune LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 14, 2005
• First Posted: October 18, 2005
• Study Start: August 1, 2002
• Primary Completion: August 1, 2003
• Study Completion: April 1, 2004
• Last Updated: November 20, 2008

Record last verified: 2008-11

Locations

US (1)