Half vs Full Dose Influenza Vaccine

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®.

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.