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

• Sponsor: MedImmune LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00192140
• Collaborator: (none)
• Enrollment: 345
• Locations: 11
• Arm: 1
• Duration (Months): 7
• Patients Per Site: 31.4
• Patients Per Site Per Month: 4.5

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Influenza	Biological: FluMist	Phase 4

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.

Study Design

• Study Type: Interventional
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: Jun 1, 2004
• Actual Primary Completion Date: Oct 1, 2004
• Actual Study Completion Date: Jan 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 FluMist	Biological: FluMist; A single intranasal dose of FluMist will be administered to approx. 300 subjects.

Outcome Measures

Primary Outcome Measures

1. To describe the proportion of individuals 5-49 years of age who shed vaccine strain viruses. [28 days after vaccination]

2. To describe the duration of shedding of vaccine viruses in individuals 5-49 years of age. [28 days after vaccination]

Secondary Outcome Measures

1. To describe the immune responses of FluMist in indivduals 5-49 years of age. [28 days after vaccination]

2. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 49 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	SFBC International, Inc	Miami	Florida	United States	33181
2	Children's Memorial Hospital	Chicago	Illinois	United States	60614
3	Kentucky Pediatric / Adult Research, Inc	Bardstown	Kentucky	United States	40004
4	University of Maryland, School of Medicine	Baltimore	Maryland	United States	21201
5	Center for Vaccine Development	Saint Louis	Missouri	United States	63110
6	Creighton University Medical Center	Omaha	Nebraska	United States	68131
7	Pediatric Clinical Trials International	Columbus	Ohio	United States	43205
8	Primary Physician's Research Inc.	Pittsburgh	Pennsylvania	United States	15241
9	Vanderbilt University Medical Center North	Nashville	Tennessee	United States	37232
10	University of Virginia, Elson Student Health Center	Charlottesville	Virginia	United States	22904
11	Marshall University Medical Center	Huntington	West Virginia	United States	25701

Sponsors and Collaborators

• MedImmune LLC

Investigators

• Study Director: Robert Walker, MD, Sponsor GmbH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00192140
• Other Study ID Numbers: FM026
• First Posted: Sep 19, 2005
• Last Update Posted: Dec 28, 2007
• Last Verified: Dec 1, 2007

Study Results

No Results Posted as of Dec 28, 2007