Comparison of Full-dose Flu Vaccine to Half-dose Flu Vaccine
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Fluzone® (Aventis Pasteur inactivated influenza vaccine)
Intervention description: A/H1N1, A/New Caledonia/20/99; A/H3N2, A/Fujian/411/2002; B, B/Shanghai/361/2002
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 1316.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza

Summary:

      This study compared full-dose Flu vaccine to half-dose Flu-vaccine during the 2004-2005 flu
      season.
    

Eligibility 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.

          -  DEERS eligible beneficiaries eligible for influenza vaccination and able to give
             informed consent.

          -  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.