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

NCT ID: NCT00283283

Last Updated: 2021-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 1316 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-11-30
• Study Completion Date: 2006-05-31

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.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Male, Age 18 -49, Full Dose

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

Group Type: EXPERIMENTAL

Fluzone® (Aventis Pasteur inactivated influenza vaccine)

Intervention Type: BIOLOGICAL

A/H1N1, A/New Caledonia/20/99; A/H3N2, A/Fujian/411/2002; B, B/Shanghai/361/2002

Male, Age 50 -64, Half Dose

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

Group Type: EXPERIMENTAL

Fluzone® (Aventis Pasteur inactivated influenza vaccine)

Intervention Type: BIOLOGICAL

A/H1N1, A/New Caledonia/20/99; A/H3N2, A/Fujian/411/2002; B, B/Shanghai/361/2002

Female, Age 18 - 49, Full Dose

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

Group Type: EXPERIMENTAL

Fluzone® (Aventis Pasteur inactivated influenza vaccine)

Intervention Type: BIOLOGICAL

A/H1N1, A/New Caledonia/20/99; A/H3N2, A/Fujian/411/2002; B, B/Shanghai/361/2002

Female, Age 18 - 49, Half Dose

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

Group Type: EXPERIMENTAL

Fluzone® (Aventis Pasteur inactivated influenza vaccine)

Intervention Type: BIOLOGICAL

A/H1N1, A/New Caledonia/20/99; A/H3N2, A/Fujian/411/2002; B, B/Shanghai/361/2002

Male, Age 18 - 49, Half Dose

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

Group Type: EXPERIMENTAL

Fluzone® (Aventis Pasteur inactivated influenza vaccine)

Intervention Type: BIOLOGICAL

A/H1N1, A/New Caledonia/20/99; A/H3N2, A/Fujian/411/2002; B, B/Shanghai/361/2002

Male, Age 50 -64, Full Dose

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

Group Type: EXPERIMENTAL

Fluzone® (Aventis Pasteur inactivated influenza vaccine)

Intervention Type: BIOLOGICAL

A/H1N1, A/New Caledonia/20/99; A/H3N2, A/Fujian/411/2002; B, B/Shanghai/361/2002

Female, Age 50 -64, Full Dose

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

Group Type: EXPERIMENTAL

Fluzone® (Aventis Pasteur inactivated influenza vaccine)

Intervention Type: BIOLOGICAL

A/H1N1, A/New Caledonia/20/99; A/H3N2, A/Fujian/411/2002; B, B/Shanghai/361/2002

Female, Age 50 -64, Half Dose

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

Group Type: EXPERIMENTAL

Fluzone® (Aventis Pasteur inactivated influenza vaccine)

Intervention Type: BIOLOGICAL

A/H1N1, A/New Caledonia/20/99; A/H3N2, A/Fujian/411/2002; B, B/Shanghai/361/2002

Interventions

Fluzone® (Aventis Pasteur inactivated influenza vaccine)

A/H1N1, A/New Caledonia/20/99; A/H3N2, A/Fujian/411/2002; B, B/Shanghai/361/2002

Intervention Type: BIOLOGICAL

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

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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Walter Reed Army Medical Center

FED

Sponsor Role: collaborator

United States Army Medical Materiel Development Activity

FED

Sponsor Role: collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

Uniformed Services University of the Health Sciences

FED

Sponsor Role: collaborator

Walter Reed Army Institute of Research (WRAIR)

FED

Sponsor Role: collaborator

U.S. Air Force Office of the Surgeon General

FED

Sponsor Role: collaborator

U.S. Army Medical Research and Development Command

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Renata J Engler, M.D

Role: PRINCIPAL_INVESTIGATOR

Walter Reed Army Medical Center

Locations

Pentagon

Washington D.C., District of Columbia, United States

Walter Reed Army Medical Center

Washington D.C., District of Columbia, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 19064822 (View on PubMed)

Other Identifiers

A-13205

Identifier Type: -

Identifier Source: org_study_id