|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | MedImmune LLC |
|---|---|
| Information provided by: | MedImmune LLC |
| ClinicalTrials.gov Identifier: | NCT00192140 |
Purpose
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza |
Biological: FluMist |
Phase IV |
| 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 |
| 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.
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and 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 | |
| Study Director: | Robert Walker, MD | Sponsor GmbH |
More Information
| 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 |
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |