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

NCT00283283 | Completed Phase 2 Results

• 1 other identifier: A-13205
• Study Type: interventional
• Target: 1,316
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Influenza

Keywords

Influenza

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Medical Events: Unsolicited Adverse Events

  3 - 6 months following vaccination

Other Outcomes (1)

• Race/Ethnicity Baseline Measure

  Enrollment Day

Study Arms (8)

Male, Age 18 -49, Full Dose

EXPERIMENTAL

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

Biological: Fluzone® (Aventis Pasteur inactivated influenza vaccine)

Male, Age 50 -64, Half Dose

EXPERIMENTAL

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

Biological: Fluzone® (Aventis Pasteur inactivated influenza vaccine)

Female, Age 18 - 49, Full Dose

EXPERIMENTAL

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

Biological: Fluzone® (Aventis Pasteur inactivated influenza vaccine)

Female, Age 18 - 49, Half Dose

EXPERIMENTAL

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

Biological: Fluzone® (Aventis Pasteur inactivated influenza vaccine)

Male, Age 18 - 49, Half Dose

EXPERIMENTAL

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

Biological: Fluzone® (Aventis Pasteur inactivated influenza vaccine)

Male, Age 50 -64, Full Dose

EXPERIMENTAL

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

Biological: Fluzone® (Aventis Pasteur inactivated influenza vaccine)

Female, Age 50 -64, Full Dose

EXPERIMENTAL

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

Biological: Fluzone® (Aventis Pasteur inactivated influenza vaccine)

Female, Age 50 -64, Half Dose

EXPERIMENTAL

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

Biological: Fluzone® (Aventis Pasteur inactivated influenza vaccine)

Interventions

Fluzone® (Aventis Pasteur inactivated influenza vaccine) 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; Female, Age 18 - 49, Half Dose; Female, Age 50 -64, Full Dose; Female, Age 50 -64, Half Dose; Male, Age 18 - 49, Half Dose; Male, Age 18 -49, Full Dose; Male, Age 50 -64, Full Dose; Male, Age 50 -64, Half Dose

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

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

Study Sites (2)

Pentagon

Washington D.C., District of Columbia, 20050, United States

Location

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307, United States

Location

Related 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, dose, and sex effects on immune responses. Arch Intern Med. 2008 Dec 8;168(22):2405-14. doi: 10.1001/archinternmed.2008.513.

  PMID: 19064822 RESULT

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: COL Renata J. M. Engler, MD
• Organization: Walter Reed National Vaccine Healthcare Center Network

renata.engler@na.amedd.army.mil

202-782-9461

Study Officials

• Renata J Engler, M.D

  Walter Reed Army Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2006
• First Posted: January 27, 2006
• Study Start: November 1, 2004
• Primary Completion: November 1, 2004
• Study Completion: May 1, 2006
• Last Updated: February 12, 2021
• Results First Posted: June 19, 2020

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)