Comparison of Full-dose Flu Vaccine to Half-dose Flu Vaccine
Comparison of Full-dose Flu Vaccine to Half-dose Flu Vaccine
This study compared full-dose Flu vaccine to half-dose Flu-vaccine during the 2004-2005 flu
 season.
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 divided into 8
 strata based on age, gender, and previous exposure to influenza vaccine, and randomized to
 receive either half-dose (0.25mL) Fluzone® or full-dose (0.5mL) Fluzone® by intramuscular
 injection into the deltoid muscle.
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.