Half vs Full Dose Influenza Vaccine
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 ]
- 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 |
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| 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 | |
| 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 May 21, 2013