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A Prospective Study to Evaluate the Safety of a Trivalent Vaccine of New 6:2 Influenza Virus Reassortants
This study is ongoing, but not recruiting participants.
Sponsored by: MedImmune LLC
Information provided by: MedImmune LLC
ClinicalTrials.gov Identifier: NCT00677820
  Purpose

This study is designed to verify the safety of the FluMist intranasal vaccine using 3 new strains predicted by the CDC to be prevalent during this year's flu season.


Condition Intervention Phase
Influenza
Biological: FluMist
Biological: Placebo
Phase IV

MedlinePlus related topics: Flu
Drug Information available for: Influenza Vaccines Fluvirin Sucrose
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety Study
Official Title: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of a Trivalent Vaccine of New 6:2 Influenza Virus Reassortants in Healthy Adults

Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Fever - body temperature greater than or equal to 101 degrees Ferenheit [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • all solicited symptoms manifesting post-treatment [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: June 2008
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
treatment with FluMist
Biological: FluMist
Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 ml of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10:7 FFU (fluorescent focus units) of each of three cold-adapted, attenuated, 6:2 reassortant influenza strains A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006.
2: Placebo Comparator
treatment with placebo
Biological: Placebo
Placebo is supplied in intranasal sprayers containing 0.5 ml of sucrose-phosphate buffer.

Detailed Description:

The objective of this study is to assess the safety of a trivalent influenza virus vaccine containing three new 6:2 reassortants in healthy adults prior to the release of the trivalent vaccine (FluMist) containing them.

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female, 18 to 49 years of age (not yet reached their 50th birthday) at the time of study vaccination
  • Healthy by medical history and health assessment
  • Sexually active females, unless surgically sterile or at least 1 year post-menopausal, must have used an effective method of avoiding pregnancy (including oral, implanted, injectable, or transdermal contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner) for at least 30 days prior to study vaccination, and must agree to continue using such precautions for at least 90 days after study vaccination; the subject must also have a negative serum or urine pregnancy test within 14 days prior to study vaccination (if screening and study vaccination do not occur on the same day) and on the day of study vaccination prior to randomization
  • Sexually active males, unless surgically sterile, must use an effective method of birth control (condom or abstinence) and must agree to continue using such precautions for at least 30 days after study vaccination
  • Available by telephone
  • Provide written informed consent (and HIPAA authorization, if applicable)
  • Ability to understand and comply with the requirements of the protocol, as judged by the investigator
  • Ability to complete follow-up period of 180 days after study vaccination as required by the protocol

Exclusion Criteria:

  • History of hypersensitivity to any component of the vaccine, including egg or egg protein
  • History of hypersensitivity to gentamicin
  • Any condition for which the inactivated influenza vaccine is indicated, including chronic disorders of the pulmonary or cardiovascular systems (eg, asthma), chronic metabolic diseases (eg, diabetes mellitus), renal dysfunction, or hemoglobinopathies that required regular medical follow-up or hospitalization during the preceding year
  • Acute febrile (>100.0°F oral or equivalent) and/or clinically significant respiratory illness (eg, cough or sore throat) within 14 days prior to randomization
  • Any known immunosuppressive condition or immune deficiency disease, including HIV infection, or ongoing immunosuppressive therapy
  • History of Guillain-Barré syndrome
  • A household contact who is severely immunocompromised (eg, hematopoietic stem cell transplant recipient, during those periods in which the immunocompromised individual requires care in a protective environment); subject should additionally avoid close contact with severely immunocompromised individuals for at least 21 days after study vaccination
  • Receipt of any investigational agent within 30 days prior to randomization, or expected receipt through 180 days after study vaccination (use of licensed agents for indications not listed in the package insert is permitted)
  • Expected receipt of anti-pyretic or analgesic medication on a daily or every other day basis from randomization through 14 days after study vaccination Note: A daily dose of up to 81 mg of aspirin for prophylactic use is not considered a contraindication to enrollment.
  • Administration of intranasal medications within 14 days prior to randomization, or expected receipt through 14 days after study vaccination
  • Nursing mother
  • Employee of the research center, any individual involved with the conduct of the study, or any family member of such individuals
  • Any condition (eg, chronic cough, allergic rhinitis) that, in the opinion of the investigator, would interfere with evaluation of the vaccine or interpretation of study results
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00677820

Locations
United States, Florida
Covance, Daytona Beach
Daytona Beach, Florida, United States, 32117
United States, Oregon
Covance, Portland
Portland, Oregon, United States, 97239
United States, Texas
Covance, Austin
Austin, Texas, United States, 78752
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Raymond Mallory, MD MedImmune LLC
  More Information

Responsible Party: MedImmune ( Rayburn Mallory M.D. )
Study ID Numbers: MI-MA182
Study First Received: May 13, 2008
Last Updated: September 3, 2008
ClinicalTrials.gov Identifier: NCT00677820  
Health Authority: United States: Food and Drug Administration;   United States: Institutional Review Board

Keywords provided by MedImmune LLC:
Influenza
FluMist
vaccine
prevention
trivalent

Study placed in the following topic categories:
Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human
Healthy
Orthomyxoviridae Infections

Additional relevant MeSH terms:
RNA Virus Infections

ClinicalTrials.gov processed this record on January 14, 2009