A Study to Evaluate the Safety of a Monovalent Vaccine in Healthy Adults
This study has been completed.
Information provided by:
First received: May 25, 2007
Last updated: December 19, 2008
Last verified: December 2008
To assess the safety of a vaccine in healthy adults prior to the release of the vaccine (FluMist®) containing it.
Biological: Frozen FluMist®
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
||A Prospective, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate the Safety of A Monovalent Vaccine in Healthy Adults
Primary Outcome Measures:
- The primary endpoint of this study is fever ≥101°F. [ Time Frame: Study Days 0-7 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Secondary outcome measures of the study include other reported SEs and AEs that occur within 7 days after vaccination (Study Days 0-7) and all SEs and AEs that occur within 14 days after vaccination (Study Days 0-14). [ Time Frame: Study days 0-7 after vaccination; Study days 0-14 ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2007 (Final data collection date for primary outcome measure)
Active Comparator: 1
Biological: Frozen FluMist®
Monovalent vaccine is supplied in intranasal sprayers containing 0.5 mL.
Placebo Comparator: 2
Other Name: Placebo is supplied in intranasal sprayers containing 0.5 mL
The objective is to assess the safety of a monovalent vaccine of a new 6:2 influenza virus reassortant in healthy adults prior to the release of the trivalent vaccine (FluMist®) containing it.
|Ages Eligible for Study:
||18 Years to 49 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
- A 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
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: NCT00480155
|Covance Daytona Beach
|Daytona Beach, Florida, United States, 32117 |
|Portland, Oregon, United States, 97239 |
|Covance Austin CRU
|Austin, Texas, United States, 78752 |
||Rayburn Mallory, M.D.
No publications provided
ClinicalTrials.gov processed this record on November 25, 2014
||Rayburn Mallory, M.D., MedImmune LLC
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 25, 2007
||December 19, 2008
||United States: Food and Drug Administration