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

Phase 2

Completed

• Conditions: Influenza
• Interventions: Biological: Fluzone® (Aventis Pasteur inactivated influenza vaccine)

• Registration Number: NCT00283283
• Lead Sponsor: U.S. Army Medical Research and Development Command

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.

Study Timeline

• Study Start: 2004-11
• Primary Completion: 2004-11
• Study First Submitted: 2006-01-24
• Study First Submitted QC: 2006-01-24
• Study First Posted: 2006-01-27
• Study Completion: 2006-05
• Results First Submitted: 2016-12-22
• Results First Submitted QC: 2020-06-18
• Results First Posted: 2020-06-19
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-10
• Last Update Posted: 2021-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1316

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Male, Age 18 - 49, Half Dose	Fluzone® (Aventis Pasteur inactivated influenza vaccine)	0.25ml, 7.5µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinia per strain
Male, Age 18 -49, Full Dose	Fluzone® (Aventis Pasteur inactivated influenza vaccine)	0.5ml, 15µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinin antigen per strain
Female, Age 18 - 49, Full Dose	Fluzone® (Aventis Pasteur inactivated influenza vaccine)	0.5ml, 15µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinin antigen per strain
Female, Age 50 -64, Full Dose	Fluzone® (Aventis Pasteur inactivated influenza vaccine)	0.5ml, 15µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinin antigen per strain
Female, Age 50 -64, Half Dose	Fluzone® (Aventis Pasteur inactivated influenza vaccine)	0.25ml, 7.5µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinin antigen per strain
Male, Age 50 -64, Full Dose	Fluzone® (Aventis Pasteur inactivated influenza vaccine)	0.5ml, 15µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinin antigen per strain
Male, Age 50 -64, Half Dose	Fluzone® (Aventis Pasteur inactivated influenza vaccine)	0.25ml, 7.5µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinia per strain
Female, Age 18 - 49, Half Dose	Fluzone® (Aventis Pasteur inactivated influenza vaccine)	0.25ml, 7.5µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinia per strain

Primary Outcome Measures

Name	Time	Method
Immune Response: Age 18-49	21 days post-vaccincation	Immune response as measured by viral strain specific hemaggluttination inhibition (HAI) antibody levels for subjects ages 18-49
Immune Response: Age 50-64	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

Name	Time	Method
Medical Events: Unsolicited Adverse Events	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.

Trial Locations

Locations (2)

Walter Reed Army Medical Center; 🇺🇸 Washington, District of Columbia, United States

Pentagon; 🇺🇸 Washington, District of Columbia, United States