Half vs Full Dose Influenza Vaccine

This study has been completed.
Sponsor:
Collaborators:
Walter Reed Army Medical Center
United States Army Medical Materiel Development Activity
Uniformed Services University of the Health Sciences
Walter Reed Army Institute of Research (WRAIR)
U.S. Air Force Office of the Surgeon General
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT00283283
First received: January 24, 2006
Last updated: January 3, 2013
Last verified: January 2013

January 24, 2006
January 3, 2013
November 2004
November 2004   (final data collection date for primary outcome measure)
Immune response as measured by viral strain specific hemaggluttination inhibition (HAI) antibody levels [ Time Frame: Pre-vaccination and 21 days post-vaccincation ] [ Designated as safety issue: No ]
Immune response as measured by viral strain specific hemaggluttination inhibition antibody levels
Complete list of historical versions of study NCT00283283 on ClinicalTrials.gov Archive Site
  • 1. Medical events - upper respiratory illness and/or pneumonia [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • 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
Not Provided
Not Provided
 
Half vs Full Dose Influenza Vaccine
Clinical Study to Compare the Immune Response of Half Dose Trivalent Inactivated Influenza Vaccine (TIV) to Full Dose

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 stratified by age, gender, and previous exposure to influenza vaccine, and randomized to receive either half-dose Fluzone® or full-dose Fluzone®.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Influenza
Biological: Fluzone® (Aventis Pasteur inactivated influenza vaccine)
A/H1N1, A/New Caledonia/20/99; A/H3N2, A/Fujian/411/2002; B, B/Shanghai/361/2002
  • Experimental: Male, Age 18 -49, Full Dose
    0.5ml, 15µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinin antigen per strain
    Intervention: Biological: Fluzone® (Aventis Pasteur inactivated influenza vaccine)
  • Experimental: Male, Age 50 -64 years, Half Dose
    0.25ml, 7.5µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinia per strain
    Intervention: Biological: Fluzone® (Aventis Pasteur inactivated influenza vaccine)
  • Experimental: Female, Age 18 - 49, Full Dose
    0.5ml, 15µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinin antigen per strain
    Intervention: Biological: Fluzone® (Aventis Pasteur inactivated influenza vaccine)
  • Experimental: Female, Age 18 - 49, Half Dose
    0.25ml, 7.5µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinia per strain
    Intervention: Biological: Fluzone® (Aventis Pasteur inactivated influenza vaccine)
  • Experimental: Male, Age 18 - 49, Half Dose
    0.25ml, 7.5µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinia per strain
    Intervention: Biological: Fluzone® (Aventis Pasteur inactivated influenza vaccine)
  • Experimental: Male, Age 50 -64, Full Dose
    0.5ml, 15µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinin antigen per strain
    Intervention: Biological: Fluzone® (Aventis Pasteur inactivated influenza vaccine)
  • Experimental: Female, Age 50 -64, Full Dose
    0.5ml, 15µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinin antigen per strain
    Intervention: Biological: Fluzone® (Aventis Pasteur inactivated influenza vaccine)
  • Experimental: Female, Age 50 -64, Half Dose
    0.25ml, 7.5µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinin antigen per strain
    Intervention: Biological: Fluzone® (Aventis Pasteur inactivated influenza vaccine)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1316
May 2006
November 2004   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00283283
A-13205
No
U.S. Army Medical Research and Materiel Command
U.S. Army Medical Research and Materiel Command
  • Walter Reed Army Medical Center
  • United States Army Medical Materiel Development Activity
  • Centers for Disease Control and Prevention
  • Uniformed Services University of the Health Sciences
  • Walter Reed Army Institute of Research (WRAIR)
  • U.S. Air Force Office of the Surgeon General
Principal Investigator: Renata J Engler, M.D Walter Reed Army Medical Center
U.S. Army Medical Research and Materiel Command
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP