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

• ClinicalTrials.gov Identifier: NCT00283283
• Recruitment Status: Completed
• First Posted: January 27, 2006
• Results First Posted: June 19, 2020
• Last Update Posted: February 12, 2021
• Sponsor: U.S. Army Medical Research and Development Command
• Collaborators: Walter Reed Army Medical Center; United States Army Medical Materiel Development Activity; Centers for Disease Control and Prevention; Uniformed Services University of the Health Sciences; Walter Reed Army Institute of Research (WRAIR); U.S. Air Force Office of the Surgeon General
• Information provided by (Responsible Party): U.S. Army Medical Research and Development Command

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Influenza	Biological: Fluzone® (Aventis Pasteur inactivated influenza vaccine)	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1316 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Clinical Study to Compare the Immune Response of Half Dose Trivalent Inactivated Influenza Vaccine (TIV) to Full Dose
• Actual Study Start Date: November 2004
• Actual Primary Completion Date: November 2004
• Actual Study Completion Date: May 2006

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Immune Response: Age 18-49 [ Time Frame: 21 days post-vaccincation ]
   Immune response as measured by viral strain specific hemaggluttination inhibition (HAI) antibody levels for subjects ages 18-49
2. Immune Response: Age 50-64 [ Time Frame: 21 days post-vaccincation ]
   Immune response as measured by viral strain specific hemaggluttination inhibition (HAI) antibody levels for subjects ages 50-64

Secondary Outcome Measures :

1. Medical Events: Unsolicited Adverse Events [ Time Frame: 3 - 6 months following vaccination ]
   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.

Other Outcome Measures:

1. Race/Ethnicity Baseline Measure [ Time Frame: Enrollment Day ]
   Race/ethnicity data was only collected by age and cannot be separated out by dose as per the other Baseline Measures

Eligibility Criteria

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

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

  • 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

Locations

United States, District of Columbia

Pentagon

Washington, District of Columbia, United States, 20050

Walter Reed Army Medical Center

Washington, District of Columbia, United States, 20307

Sponsors and Collaborators

U.S. Army Medical Research and Development Command

Walter Reed Army Medical Center

United States Army Medical Materiel Development Activity

Centers for Disease Control and Prevention

Uniformed Services University of the Health Sciences

Walter Reed Army Institute of Research (WRAIR)

U.S. Air Force Office of the Surgeon General

Investigators

• Principal Investigator: Renata J Engler, M.D; Walter Reed Army Medical Center

More Information

Publications of Results:

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.

• Responsible Party: U.S. Army Medical Research and Development Command
• ClinicalTrials.gov Identifier: NCT00283283
• Other Study ID Numbers: A-13205
• First Posted: January 27, 2006
• Results First Posted: June 19, 2020
• Last Update Posted: February 12, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by U.S. Army Medical Research and Development Command:

Influenza

Additional relevant MeSH terms:

Influenza, Human; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases