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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00240877
Recruitment Status : Completed
First Posted : October 18, 2005
Last Update Posted : November 20, 2008
Sponsor:
Information provided by:
MedImmune LLC

Tracking Information
First Submitted Date  ICMJE October 14, 2005
First Posted Date  ICMJE October 18, 2005
Last Update Posted Date November 20, 2008
Study Start Date  ICMJE August 2002
Actual Primary Completion Date August 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2008)
- The primary endpoint of this study is fever defined as oral temperature ≥101°F [ Time Frame: Days 0-7 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 14, 2005)
- The primary endpoint of this study is fever defined as oral temperature ≥101°F
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2008)
All other reported reactogenicity events and other adverse events. [ Time Frame: After 7 days after vaccination ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2005)
- "N/A"
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Safety of a Monovalent Vaccine of a New 6:2 Reassortant in Healthy Adults (AV024)
Official Title  ICMJE 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)
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Influenza
Intervention  ICMJE
  • 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).
Study Arms  ICMJE
  • Experimental: 1
    Monovalent vaccine prior to the release of the trivalent vaccine (FluMist).
    Intervention: Biological: AV024
  • Placebo Comparator: 2
    Placebo
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 19, 2008)
330
Original Enrollment  ICMJE
 (submitted: October 14, 2005)
300
Actual Study Completion Date  ICMJE April 2004
Actual Primary Completion Date August 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00240877
Other Study ID Numbers  ICMJE AV024
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Robert Walker, M.D., MedImmune Inc.
Study Sponsor  ICMJE MedImmune LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Robert Walker, MD MedImmune LLC
PRS Account MedImmune LLC
Verification Date November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP