Trial to Assess the Shedding,Immunogenicity, and Safety of FluMist Administered to Healthy Individuals 5-49 Years of Age

This study has been completed.
Sponsor:
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00192140
First received: September 9, 2005
Last updated: December 27, 2007
Last verified: December 2007
  Purpose
  • To describe the proportion of individuals 5-49 years of age who shed vaccine strain viruses.
  • To describe the duration of shedding of vaccine viruses in individuals 5-49 years of age.
  • To describe the genotypic and phenotypic stability of shed vaccine viruses.
  • To describe the immune responses of FluMist in individuals 5-49 years of age.
  • To describe the safety of FluMist in individuals 5-49 years of age in relation to shedding and the immune response

Condition Intervention Phase
Influenza
Biological: FluMist
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Single-Arm Trial to Assess the Shedding, Immunogenicity, and Safety of FluMist Administered to Healthy Individuals 5-49 Years of Age

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • To describe the proportion of individuals 5-49 years of age who shed vaccine strain viruses. [ Time Frame: 28 days after vaccination ] [ Designated as safety issue: No ]
  • To describe the duration of shedding of vaccine viruses in individuals 5-49 years of age. [ Time Frame: 28 days after vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To describe the immune responses of FluMist in indivduals 5-49 years of age. [ Time Frame: 28 days after vaccination ] [ Designated as safety issue: No ]
  • To describe the safety of FluMist in individuals 5-49 years of age in relation to shedding and the immune response. [ Time Frame: 28 days after vaccination ] [ Designated as safety issue: No ]

Estimated Enrollment: 345
Study Start Date: June 2004
Study Completion Date: January 2005
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
FluMist
Biological: FluMist
A single intranasal dose of FluMist will be administered to approx. 300 subjects.

Detailed Description:

The purpose of this study is to evaluate the viral shedding, immunogenicity and safety of FluMist when administered to healthy individuals between 5-49 years of age.

  Eligibility

Ages Eligible for Study:   5 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 5-49 years of age;
  • In good health;
  • Individual or parent/guardian available by telephone;
  • Ability of the participant or parent/guardian to understand and comply with the requirements of the protocol; and
  • Signed informed consent and HIPAA authorization by the participant or parent/guardian.

Exclusion Criteria:

  • History of hypersensitivity to any component of FluMist, including egg or egg products;
  • History of hypersensitivity to gentamicin;
  • Close contact who is immunocompromised within the same household;
  • Known or suspected immune deficiency diseases or immunosuppressed or have altered or compromised immune status as a consequence of treatment with immunosuppressive therapies;
  • History of chronic underlying medical conditions such as chronic disorders of the cardiovascular and pulmonary systems, chronic metabolic diseases (including diabetes), renal dysfunction, or hemoglobinopathies;
  • History of Guillain-Barré syndrome;
  • History of asthma or reactive airways disease;
  • Acute febrile (>100.0°F oral) and/or respiratory illness, within the 72 hours prior to enrollment;
  • For children and adolescents - use of aspirin or aspirin containing products in the month prior to enrollment or anticipated use during the study;
  • Pregnancy or, in biologically capable women (e.g., menses within the last year), not willing to agree to acceptable birth control for three months after enrolling into the study (for those biologically capable, a urine pregnancy test must be performed on the day of vaccination with a negative result);
  • Administration of any intranasal medication within two weeks prior to enrollment or expected receipt during this study;
  • Administration of any live virus vaccine within one month prior to enrollment or if receipt of another live virus vaccine is expected within one month of the vaccination in this study;
  • Administration of any inactivated vaccine within two weeks prior to enrollment or if receipt of another inactivated vaccine is expected within two weeks of the vaccination in this study;
  • Participation in another investigational trial or administration of any investigational drug within one month prior to enrollment or during this study;
  • Employees of the research center, any individuals involved with the conduct of the study, or any family member of such individuals;
  • Laboratory confirmed influenza (positive culture or rapid antigen test) in the prior influenza season (2003/2004 or 2004/2005 season);
  • Receipt of any influenza vaccine in the prior influenza season; and
  • Any condition that in the opinion of the investigator would interfere with the interpretation or evaluation of the vaccine.
  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: NCT00192140

Locations
United States, Florida
SFBC International, Inc
Miami, Florida, United States, 33181
United States, Illinois
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
United States, Kentucky
Kentucky Pediatric / Adult Research, Inc
Bardstown, Kentucky, United States, 40004
United States, Maryland
University of Maryland, School of Medicine
Baltimore, Maryland, United States, 21201
United States, Missouri
Center for Vaccine Development
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Creighton University Medical Center
Omaha, Nebraska, United States, 68131
United States, Ohio
Pediatric Clinical Trials International
Columbus, Ohio, United States, 43205
United States, Pennsylvania
Primary Physician's Research Inc.
Pittsburgh, Pennsylvania, United States, 15241
United States, Tennessee
Vanderbilt University Medical Center North
Nashville, Tennessee, United States, 37232
United States, Virginia
University of Virginia, Elson Student Health Center
Charlottesville, Virginia, United States, 22904
United States, West Virginia
Marshall University Medical Center
Huntington, West Virginia, United States, 25701
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Robert Walker, MD Sponsor GmbH
  More Information

No publications provided

Responsible Party: Chris Ambrose, Dir. Medical Affairs, MedImmune Inc.
ClinicalTrials.gov Identifier: NCT00192140     History of Changes
Other Study ID Numbers: FM026
Study First Received: September 9, 2005
Last Updated: December 27, 2007
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 August 20, 2014