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

This study has been completed.
Sponsor:
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00240877
First received: October 14, 2005
Last updated: November 19, 2008
Last verified: November 2008
  Purpose

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


Condition Intervention Phase
Influenza
Biological: AV024
Other: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • - The primary endpoint of this study is fever defined as oral temperature ≥101°F [ Time Frame: Days 0-7 ]

Secondary Outcome Measures:
  • All other reported reactogenicity events and other adverse events. [ Time Frame: After 7 days after vaccination ] [ Designated as safety issue: Yes ]

Enrollment: 330
Study Start Date: August 2002
Study Completion Date: April 2004
Primary Completion Date: August 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Monovalent vaccine prior to the release of the trivalent vaccine (FluMist).
Biological: AV024
0.5 mL total dose volume administered intranasal by spray applicator (approximately 0.25 mL into each nostril).
Placebo Comparator: 2
Placebo
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00240877

Locations
United States, Florida
SFBC International Inc
Miami, Florida, United States, 33181
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Robert Walker, MD MedImmune LLC
  More Information

No publications provided

Responsible Party: Robert Walker, M.D., MedImmune Inc.
ClinicalTrials.gov Identifier: NCT00240877     History of Changes
Other Study ID Numbers: AV024
Study First Received: October 14, 2005
Last Updated: November 19, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 14, 2014