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Comparison of Full-dose Flu Vaccine to Half-dose Flu Vaccine

Primary Purpose

Influenza

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fluzone® (Aventis Pasteur inactivated influenza vaccine)
Sponsored by
U.S. Army Medical Research and Development Command
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Pentagon
  • Walter Reed Army Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Male, Age 18 -49, Full Dose

Male, Age 50 -64, Half Dose

Female, Age 18 - 49, Full Dose

Female, Age 18 - 49, Half Dose

Male, Age 18 - 49, Half Dose

Male, Age 50 -64, Full Dose

Female, Age 50 -64, Full Dose

Female, Age 50 -64, Half Dose

Arm Description

0.5ml, 15µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinin antigen per strain

0.25ml, 7.5µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinia per strain

0.5ml, 15µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinin antigen per strain

0.25ml, 7.5µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinia per strain

0.25ml, 7.5µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinia per strain

0.5ml, 15µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinin antigen per strain

0.5ml, 15µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinin antigen per strain

0.25ml, 7.5µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinin antigen per strain

Outcomes

Primary Outcome Measures

Immune Response: Age 18-49
Immune response as measured by viral strain specific hemaggluttination inhibition (HAI) antibody levels for subjects ages 18-49
Immune Response: Age 50-64
Immune response as measured by viral strain specific hemaggluttination inhibition (HAI) antibody levels for subjects ages 50-64

Secondary Outcome Measures

Medical Events: Unsolicited Adverse Events
Assessed through following subjects' recording of oral body temperature, completion of a 21-day symptom diary; subjects' completion of longer-term follow-up surveys to track respiratory symptoms; and a review of the Defense Medical Surveillance System (DMSS) hospitalization and outpatient medical visits database in order to track ICD-9 codes relevant to flu-like illness.

Full Information

First Posted
January 24, 2006
Last Updated
February 10, 2021
Sponsor
U.S. Army Medical Research and Development Command
Collaborators
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
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1. Study Identification

Unique Protocol Identification Number
NCT00283283
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
November 2004 (Actual)
Primary Completion Date
November 2004 (Actual)
Study Completion Date
May 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
U.S. Army Medical Research and Development Command
Collaborators
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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1316 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Male, Age 18 -49, Full Dose
Arm Type
Experimental
Arm Description
0.5ml, 15µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinin antigen per strain
Arm Title
Male, Age 50 -64, Half Dose
Arm Type
Experimental
Arm Description
0.25ml, 7.5µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinia per strain
Arm Title
Female, Age 18 - 49, Full Dose
Arm Type
Experimental
Arm Description
0.5ml, 15µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinin antigen per strain
Arm Title
Female, Age 18 - 49, Half Dose
Arm Type
Experimental
Arm Description
0.25ml, 7.5µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinia per strain
Arm Title
Male, Age 18 - 49, Half Dose
Arm Type
Experimental
Arm Description
0.25ml, 7.5µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinia per strain
Arm Title
Male, Age 50 -64, Full Dose
Arm Type
Experimental
Arm Description
0.5ml, 15µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinin antigen per strain
Arm Title
Female, Age 50 -64, Full Dose
Arm Type
Experimental
Arm Description
0.5ml, 15µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinin antigen per strain
Arm Title
Female, Age 50 -64, Half Dose
Arm Type
Experimental
Arm Description
0.25ml, 7.5µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinin antigen per strain
Intervention Type
Biological
Intervention Name(s)
Fluzone® (Aventis Pasteur inactivated influenza vaccine)
Intervention Description
A/H1N1, A/New Caledonia/20/99; A/H3N2, A/Fujian/411/2002; B, B/Shanghai/361/2002
Primary Outcome Measure Information:
Title
Immune Response: Age 18-49
Description
Immune response as measured by viral strain specific hemaggluttination inhibition (HAI) antibody levels for subjects ages 18-49
Time Frame
21 days post-vaccincation
Title
Immune Response: Age 50-64
Description
Immune response as measured by viral strain specific hemaggluttination inhibition (HAI) antibody levels for subjects ages 50-64
Time Frame
21 days post-vaccincation
Secondary Outcome Measure Information:
Title
Medical Events: Unsolicited Adverse Events
Description
Assessed through following subjects' recording of oral body temperature, completion of a 21-day symptom diary; subjects' completion of longer-term follow-up surveys to track respiratory symptoms; and a review of the Defense Medical Surveillance System (DMSS) hospitalization and outpatient medical visits database in order to track ICD-9 codes relevant to flu-like illness.
Time Frame
3 - 6 months following vaccination
Other Pre-specified Outcome Measures:
Title
Race/Ethnicity Baseline Measure
Description
Race/ethnicity data was only collected by age and cannot be separated out by dose as per the other Baseline Measures
Time Frame
Enrollment Day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renata J Engler, M.D
Organizational Affiliation
Walter Reed Army Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pentagon
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20050
Country
United States
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20307
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19064822
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.
Results Reference
result

Learn more about this trial

Comparison of Full-dose Flu Vaccine to Half-dose Flu Vaccine

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