Study To Evaluate the Safety of Bivalent Vaccine

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. Identifier: NCT00325481
Recruitment Status : Completed
First Posted : May 12, 2006
Last Update Posted : July 18, 2007
Information provided by:
MedImmune LLC

Brief Summary:
To assess the safety of a bivalent vaccine of two new influenza virus reassortants in healthy adults prior to the release of the trivalent vaccine (FluMist) containing them.

Condition or disease Intervention/treatment Phase
Healthy Drug: FluMist Phase 3

Detailed Description:
This prospective, randomized, double blind, placebo-controlled release study will enroll approximately 300 healthy adults 18-49 years of age. Eligible subjects will be randomly assigned in a 4:1 fashion to receive a single dose of bivalent vaccine or placebo by intranasal spray. This study will be conducted at multiple sites in the United States. Randomization will be stratified by site.

Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of a Bivalent Vaccine of New 6:2 Influenza Virus Reassortants in Healthy Adults
Study Start Date : June 2006
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Shot

Primary Outcome Measures :
  1. The primary endpoint of this study is fever (Study Days 0-7), defined as oral temperature of at least 101°F.

Secondary Outcome Measures :
  1. Secondary endpoints of the study include other reported REs and AEs that occur within 7 days after vaccination (Study Days 0-7) and all REs and AEs that occur within 14 days after vaccination (Study Days 0-14).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  • Written informed consent (and HIPAA authorization if applicable) obtained from the subject
  • 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 of 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 (e.g., asthma), chronic metabolic diseases (e.g., 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 (e.g., cough or sore throat) within the 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
  • Household contact who is severely immunocompromised (e.g., 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 (e.g., chronic cough, allergic rhinitis) that in the opinion of the investigator would interfere with evaluation of the vaccine or interpretation of study results

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00325481

United States, Florida
Radiant Research, Daytona Beach
Daytona Beach, Florida, United States, 32114
United States, Oregon
Radiant Research
Portland, Oregon, United States, 97239
United States, Texas
Heathcare Discoveries, Inc.
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
MedImmune LLC
Study Director: Maria Allende, M.D. MedImmune LLC Identifier: NCT00325481     History of Changes
Other Study ID Numbers: MI-CP134
First Posted: May 12, 2006    Key Record Dates
Last Update Posted: July 18, 2007
Last Verified: July 2007