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

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

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

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: Fluzone® (Aventis Pasteur inactivated influenza vaccine)

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.

• Study Type: Interventional
• Enrollment (Actual): 1316
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20307
      • Walter Reed Army Medical Center
    • Washington, District of Columbia, United States, 20050
      • Pentagon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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, 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: U.S. Army Medical Research and Development Command
• Collaborators: Walter Reed Army Medical Center; Walter Reed Army Institute of Research (WRAIR); Centers for Disease Control and Prevention; Uniformed Services University of the Health Sciences; United States Army Medical Materiel Development Activity; U.S. Air Force Office of the Surgeon General
• Investigators: Principal Investigator: Renata J Engler, M.D, Walter Reed Army Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2004
• Primary Completion (Actual): November 1, 2004
• Study Completion (Actual): May 1, 2006

Study Registration Dates

• First Submitted: January 24, 2006
• First Submitted That Met QC Criteria: January 24, 2006
• First Posted (Estimate): January 27, 2006

Study Record Updates

• Last Update Posted (Actual): February 12, 2021
• Last Update Submitted That Met QC Criteria: February 10, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Influenza
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: A-13205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO