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

NCT00192140 | Completed Phase 4 DMC

• 1 other identifier: FM026
• Study Type: interventional
• Target: 345
• Locations: 1 country
• Sites: 11

Brief Summary

• 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

Conditions

Influenza

Outcome Measures

Primary Outcomes (2)

• To describe the proportion of individuals 5-49 years of age who shed vaccine strain viruses.

  28 days after vaccination

• To describe the duration of shedding of vaccine viruses in individuals 5-49 years of age.

  28 days after vaccination

Secondary Outcomes (2)

• To describe the immune responses of FluMist in indivduals 5-49 years of age.

  28 days after vaccination

• To describe the safety of FluMist in individuals 5-49 years of age in relation to shedding and the immune response.

  28 days after vaccination

Study Arms (1)

1

ACTIVE COMPARATOR

FluMist

Biological: FluMist

Interventions

FluMist BIOLOGICAL

A single intranasal dose of FluMist will be administered to approx. 300 subjects.

1

Eligibility Criteria

• Age: 5 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (11)

SFBC International, Inc

Miami, Florida, 33181, United States

Location

Children's Memorial Hospital

Chicago, Illinois, 60614, United States

Location

Kentucky Pediatric / Adult Research, Inc

Bardstown, Kentucky, 40004, United States

Location

University of Maryland, School of Medicine

Baltimore, Maryland, 21201, United States

Location

Center for Vaccine Development

St Louis, Missouri, 63110, United States

Location

Creighton University Medical Center

Omaha, Nebraska, 68131, United States

Location

Pediatric Clinical Trials International

Columbus, Ohio, 43205, United States

Location

Primary Physician's Research Inc.

Pittsburgh, Pennsylvania, 15241, United States

Location

Vanderbilt University Medical Center North

Nashville, Tennessee, 37232, United States

Location

University of Virginia, Elson Student Health Center

Charlottesville, Virginia, 22904, United States

Location

Marshall University Medical Center

Huntington, West Virginia, 25701, United States

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

FluMist

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Robert Walker, MD

  Sponsor GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 19, 2005
• Study Start: June 1, 2004
• Primary Completion: October 1, 2004
• Study Completion: January 1, 2005
• Last Updated: December 28, 2007

Record last verified: 2007-12

Locations

US (11)