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

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00283283
• Other study ID #: A-13205
• Status: Completed
• Phase: Phase 2
• Start date: November 2004
• Est. completion date: May 2006

Study information

• Verified date: February 2021
• Source: U.S. Army Medical Research and Development Command
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1316
• Est. completion date: May 2006
• Est. primary completion date: November 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

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

Locations

Country	Name	City	State
United States	Pentagon	Washington	District of Columbia
United States	Walter Reed Army Medical Center	Washington	District of Columbia

Sponsors (7)

Lead Sponsor	Collaborator
U.S. Army Medical Research and Development Command	Centers for Disease Control and Prevention, U.S. Air Force Office of the Surgeon General, Uniformed Services University of the Health Sciences, United States Army Medical Materiel Development Activity, Walter Reed Army Institute of Research (WRAIR), Walter Reed Army Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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, d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Race/Ethnicity Baseline Measure	Race/ethnicity data was only collected by age and cannot be separated out by dose as per the other Baseline Measures	Enrollment Day
Primary	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
Primary	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	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