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

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

Detailed Description
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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.

Official Title
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Clinical Study to Compare the Immune Response of Half Dose Trivalent Inactivated Influenza Vaccine (TIV) to Full Dose

Conditions
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Influenza

Intervention / Treatment
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* Biological: Fluzone® (Aventis Pasteur inactivated influenza vaccine)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Male, Age 18 -49, Full Dose<br>0.5ml, 15µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinin antigen per strain | Biological: Fluzone® (Aventis Pasteur inactivated influenza vaccine)<br>* A/H1N1, A/New Caledonia/20/99; A/H3N2, A/Fujian/411/2002; B, B/Shanghai/361/2002<br>|
| Experimental: Male, Age 50 -64, Half Dose<br>0.25ml, 7.5µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinia per strain | Biological: Fluzone® (Aventis Pasteur inactivated influenza vaccine)<br>* A/H1N1, A/New Caledonia/20/99; A/H3N2, A/Fujian/411/2002; B, B/Shanghai/361/2002<br>|
| Experimental: Female, Age 18 - 49, Full Dose<br>0.5ml, 15µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinin antigen per strain | Biological: Fluzone® (Aventis Pasteur inactivated influenza vaccine)<br>* A/H1N1, A/New Caledonia/20/99; A/H3N2, A/Fujian/411/2002; B, B/Shanghai/361/2002<br>|
| Experimental: Female, Age 18 - 49, Half Dose<br>0.25ml, 7.5µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinia per strain | Biological: Fluzone® (Aventis Pasteur inactivated influenza vaccine)<br>* A/H1N1, A/New Caledonia/20/99; A/H3N2, A/Fujian/411/2002; B, B/Shanghai/361/2002<br>|
| Experimental: Male, Age 18 - 49, Half Dose<br>0.25ml, 7.5µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinia per strain | Biological: Fluzone® (Aventis Pasteur inactivated influenza vaccine)<br>* A/H1N1, A/New Caledonia/20/99; A/H3N2, A/Fujian/411/2002; B, B/Shanghai/361/2002<br>|
| Experimental: Male, Age 50 -64, Full Dose<br>0.5ml, 15µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinin antigen per strain | Biological: Fluzone® (Aventis Pasteur inactivated influenza vaccine)<br>* A/H1N1, A/New Caledonia/20/99; A/H3N2, A/Fujian/411/2002; B, B/Shanghai/361/2002<br>|
| Experimental: Female, Age 50 -64, Full Dose<br>0.5ml, 15µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinin antigen per strain | Biological: Fluzone® (Aventis Pasteur inactivated influenza vaccine)<br>* A/H1N1, A/New Caledonia/20/99; A/H3N2, A/Fujian/411/2002; B, B/Shanghai/361/2002<br>|
| Experimental: Female, Age 50 -64, Half Dose<br>0.25ml, 7.5µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinin antigen per strain | Biological: Fluzone® (Aventis Pasteur inactivated influenza vaccine)<br>* A/H1N1, A/New Caledonia/20/99; A/H3N2, A/Fujian/411/2002; B, B/Shanghai/361/2002<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immune Response: Age 18-49 | Immune response as measured by viral strain specific hemaggluttination inhibition (HAI) antibody levels for subjects ages 18-49 | 21 days post-vaccincation | 
| Immune Response: Age 50-64 | Immune response as measured by viral strain specific hemaggluttination inhibition (HAI) antibody levels for subjects ages 50-64 | 21 days post-vaccincation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 - 6 months following vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza