Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
MedImmune LLC |
---|---|
Information provided by: | MedImmune LLC |
ClinicalTrials.gov Identifier: | NCT00125944 |
The objective is to assess the safety of bivalent vaccine of two new 6:2 influenza virus reassortants in healthy adults prior to the release of the trivalent vaccine (FluMist) containing them.
Condition | Intervention | Phase |
---|---|---|
Healthy Influenza |
Biological: FluMist |
Phase III |
Study Type: | Interventional |
Study Design: | Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study |
Official Title: | A Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of a Bivalent Vaccine of New 6:2 Influenza Virus Reassortants in Healthy Adults |
Estimated Enrollment: | 300 |
Study Start Date: | July 2005 |
Estimated Study Completion Date: | January 2006 |
Ages Eligible for Study: | 18 Years to 49 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Note: A daily dose of 81 mg of aspirin is not considered a contraindication to enrollment. Discontinuation of prophylactic use of anti-pyretic or analgesic medications at the time of enrollment and for 14 days following vaccination is not considered a contraindication to enrollment.
United States, California | |
Radiant Research, San Diego | |
San Diego, California, United States, 92123 | |
United States, Florida | |
Radiant Research, Daytona Beach | |
Daytona Beach, Florida, United States, 32114 | |
United States, Oregon | |
Radiant Research | |
Portland, Oregon, United States, 97239 | |
United States, Texas | |
Healthcare Discoveries, Inc. | |
San Antonio, Texas, United States, 78229 |
Principal Investigator: | Robert Walker, MD | MedImmune LLC |
Study ID Numbers: | MI-CP125 |
Study First Received: | August 1, 2005 |
Last Updated: | May 8, 2007 |
ClinicalTrials.gov Identifier: | NCT00125944 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Influenza, Human Healthy Orthomyxoviridae Infections |
Virus Diseases RNA Virus Infections Respiratory Tract Diseases |
Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |