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| Sponsor: | U.S. Army Office of the Surgeon General |
|---|---|
| Collaborators: |
Walter Reed Army Medical Center U.S. Army Medical Materiel Development Activity National Institute of Allergy and Infectious Diseases (NIAID) Centers for Disease Control and Prevention Uniformed Services University of the Health Sciences Walter Reed Army Institute of Research (WRAIR) U.S. Army Medical Research Institute of Infectious Diseases U.S. Army Medical Research and Materiel Command U.S. Air Force Office of the Surgeon General U.S. Navy Bureau of Medicine |
| Information provided by: | U.S. Army Medical Research and Materiel Command |
| ClinicalTrials.gov Identifier: | NCT00283283 |
Purpose
This study compared full-dose Flu vaccine to half-dose Flu-vaccine during the 2004-2005 flu season.
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza |
Biological: Fluzone® (Aventis Pasteur inactivated influenza vaccine) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Prevention |
| Official Title: | Clinical Study to Compare the Immune Response of Half Dose Trivalent Inactivated Influenza Vaccine (TIV) to Full Dose |
| Estimated Enrollment: | 1440 |
| Study Start Date: | November 2004 |
| Estimated Study Completion Date: | July 2005 |
This was a Phase II prospective, single-blind to dose, randomized study that compared the immunogenicity of subjects receiving half-dose Fluzone® compared to full-dose Fluzone®, 2004-2005 formulation. 1440 healthy subjects, ages 18-64 years old and not currently indicated for influenza vaccination under the interim ACIP guidelines, were stratified by age, gender, and previous exposure to influenza vaccine, and randomized to receive either half-dose Fluzone® or full-dose Fluzone®.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
• Able to understand and comply with all study procedures including availability for all study visits and follow up surveys within 6 months following study enrollment.
Age 18-49
Exclusion Criteria:
• all children aged < 18 years (includes children aged 6 months-18 years on chronic aspirin therapy);
persons aged 2-64 years with underlying chronic medical conditions:
Contacts and Locations| United States, District of Columbia | |
| Walter Reed Army Medical Center | |
| Washington, District of Columbia, United States, 20307 | |
| Pentagon | |
| Washington, District of Columbia, United States, 20050 | |
| Principal Investigator: | Renata J Engler, M.D | Walter Reed Army Medical Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00283283 History of Changes |
| Other Study ID Numbers: | A-13205 |
| Study First Received: | January 24, 2006 |
| Last Updated: | January 24, 2006 |
| Health Authority: | United States: Food and Drug Administration |
|
Influenza |
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |