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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014