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
  Purpose

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


Condition Intervention Phase
Influenza
Biological: Fluzone® (Aventis Pasteur inactivated influenza vaccine)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Clinical Study to Compare the Immune Response of Half Dose Trivalent Inactivated Influenza Vaccine (TIV) to Full Dose

Resource links provided by NLM:


Further study details as provided by U.S. Army Medical Research and Materiel Command:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1316
Study Start Date: November 2004
Study Completion Date: May 2006
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Male, Age 18 -49, Full Dose
0.5ml, 15µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinin antigen per strain
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 50 -64 years, Half Dose
0.25ml, 7.5µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinia per strain
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: Female, Age 18 - 49, Full Dose
0.5ml, 15µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinin antigen per strain
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: Female, Age 18 - 49, Half Dose
0.25ml, 7.5µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinia per strain
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, Half Dose
0.25ml, 7.5µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinia per strain
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 50 -64, Full Dose
0.5ml, 15µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinin antigen per strain
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: Female, Age 50 -64, Full Dose
0.5ml, 15µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinin antigen per strain
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: Female, Age 50 -64, Half Dose
0.25ml, 7.5µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinin antigen per strain
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

    • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00283283

Locations
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307
Pentagon
Washington, District of Columbia, United States, 20050
Sponsors and Collaborators
U.S. Army Medical Research and Materiel Command
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
Investigators
Principal Investigator: Renata J Engler, M.D Walter Reed Army Medical Center
  More Information

No publications provided by U.S. Army Medical Research and Materiel Command

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT00283283     History of Changes
Other Study ID Numbers: A-13205
Study First Received: January 24, 2006
Last Updated: January 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by U.S. Army Medical Research and Materiel Command:
Influenza

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 10, 2014