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Half Dose Influenza Vaccine
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2006 by U.S. Army Medical Research and Materiel Command.   Recruitment status was  Active, not recruiting

First Received on January 24, 2006.   No Changes Posted
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

Resource links provided by NLM:


Further study details as provided by U.S. Army Medical Research and Materiel Command:

Primary Outcome Measures:
  • Immune response as measured by viral strain specific hemaggluttination inhibition antibody levels

Secondary Outcome Measures:
  • 1. Medical events - upper respiratory illness and/or pneumonia
  • 2. Health care utilization and impact on productivity - number of days lost from work, hospitalizations, emergency room visits, unscheduled doctor’s visits within 3-6 months following immunization

Estimated Enrollment: 1440
Study Start Date: November 2004
Estimated Study Completion Date: July 2005
Detailed Description:

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
Criteria

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

      • Patients presenting to travel clinic with no exclusion criteria;
      • Household contacts and out-of-home caretakers of infants from 6-23 months of age;
      • Hospital and/or employees providing service to the public who are not eligible for the post-October 5th recommendations for priority immunization;
      • DOD employees eligible for influenza vaccination prior to October 5th but excluded in the post October 5th guidelines;
      • People living in dormitories or under other crowded conditions, to prevent outbreaks;
    • Ages 50-64 years of age who are not eligible for the post-October 5th recommendations for priority immunization and with no standard of care contraindications to vaccination.
    • Eligible in the Department of Defense for influenza vaccination

Exclusion Criteria:

  • • all children aged < 18 years (includes children aged 6 months-18 years on chronic aspirin therapy);

    • adults aged >65 years;
    • persons aged 2-64 years with underlying chronic medical conditions:

      • includes persons with chronic cardiac or pulmonary disease, diabetes mellitus, hemoglobinopathy, or immunosuppressive illness;
      • any acute or chronic condition that, in the opinion of the investigator, would render vaccination unsafe or interfere with the evaluation of response.
    • use of experimental vaccines or medications within 30 days of study entry;
    • receipt of parenteral immunoglobulin within 60 days of study entry;
    • all women who will be pregnant during the influenza season;
    • residents of nursing homes and long-term care facilities;
    • health-care workers involved in direct patient care and included in DOD priority 1; and;
    • military recruits;
    • out-of-home caregivers and household contacts of children aged <6 months.
    • Anyone with clinical contraindications for receiving the inactivated influenza vaccine such as a history of severe allergic reaction to prior influenza vaccinations, severe allergy to egg and/or egg proteins and gelatin.
    • DOD Priority 1: Deployed or deploying (with orders) service members and others designated as critical to national defense.
    • DOD Priority 2: Medically high risk in accordance with ACIP guidelines (includes health-care workers with direct patient contact)
    • Any acute or chronic condition that, in the opinion of the investigator or her provider designee would render vaccination unsafe or interfere with the evaluation of the response.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00283283

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
Sponsors and Collaborators
U.S. Army Office of the Surgeon General
Walter Reed Army Medical Center
U.S. Army Medical Materiel Development Activity
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
Investigators
Principal Investigator: Renata J Engler, M.D Walter Reed Army Medical Center
  More Information

No publications provided by U.S. Army Medical Research and Materiel Command

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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

Keywords provided by U.S. Army Medical Research and Materiel Command:
Influenza

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on February 08, 2012