Clinical trial NCT00283283: Comparison of Full-dose Flu Vaccine to Half-dose Flu Vaccine
Official title: Clinical Study to Compare the Immune Response of Half Dose Trivalent Inactivated Influenza Vaccine (TIV) to Full Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: Influenza
Lead sponsor: U.S. Army Medical Research and Development Command
Sponsor class: FED
Collaborators: name: Walter Reed Army Medical Center
name: United States Army Medical Materiel Development Activity
name: Centers for Disease Control and Prevention
name: Uniformed Services University of the Health Sciences
name: Walter Reed Army Institute of Research (WRAIR)
name: U.S. Air Force Office of the Surgeon General
First posted: 2006-01-27
Enrollment: 1316
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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 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.

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.

Primary outcomes:
measure: Immune Response: Age 18-49
timeFrame: 21 days post-vaccincation
measure: Immune Response: Age 50-64
timeFrame: 21 days post-vaccincation
Secondary outcomes:
measure: Medical Events: Unsolicited Adverse Events
timeFrame: 3 - 6 months following vaccination
Other outcomes:
measure: Race/Ethnicity Baseline Measure
timeFrame: Enrollment Day
Locations:
city: Washington
country: United States
facility: Pentagon
state: District of Columbia
city: Washington
country: United States
facility: Walter Reed Army Medical Center
state: District of Columbia
Study officials:
affiliation: Walter Reed Army Medical Center
name: Renata J Engler, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Engler RJ, Nelson MR, Klote MM, VanRaden MJ, Huang CY, Cox NJ, Klimov A, Keitel WA, Nichol KL, Carr WW, Treanor JJ; Walter Reed Health Care System Influenza Vaccine Consortium. Half- vs full-dose trivalent inactivated influenza vaccine (2004-2005): age, dose, and sex effects on immune responses. Arch Intern Med. 2008 Dec 8;168(22):2405-14. doi: 10.1001/archinternmed.2008.513.