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

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00192140
• Other study ID #: FM026
• Status: Completed
• Phase: Phase 4
• First received: September 9, 2005
• Last updated: December 27, 2007
• Start date: June 2004
• Est. completion date: January 2005

Study information

• Verified date: December 2007
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 345
• Est. completion date: January 2005
• Est. primary completion date: October 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 49 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Influenza

Intervention

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

Locations

Country	Name	City	State
United States	University of Maryland, School of Medicine	Baltimore	Maryland
United States	Kentucky Pediatric / Adult Research, Inc	Bardstown	Kentucky
United States	University of Virginia, Elson Student Health Center	Charlottesville	Virginia
United States	Children's Memorial Hospital	Chicago	Illinois
United States	Pediatric Clinical Trials International	Columbus	Ohio
United States	Marshall University Medical Center	Huntington	West Virginia
United States	SFBC International, Inc	Miami	Florida
United States	Vanderbilt University Medical Center North	Nashville	Tennessee
United States	Creighton University Medical Center	Omaha	Nebraska
United States	Primary Physician's Research Inc.	Pittsburgh	Pennsylvania
United States	Center for Vaccine Development	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
MedImmune LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To describe the proportion of individuals 5-49 years of age who shed vaccine strain viruses.		28 days after vaccination	No
Primary	To describe the duration of shedding of vaccine viruses in individuals 5-49 years of age.		28 days after vaccination	No
Secondary	To describe the immune responses of FluMist in indivduals 5-49 years of age.		28 days after vaccination	No
Secondary	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	No