Half-Dose Flu Vaccine Study in Healthy Adults

Evaluation of the Immunogenicity of Low Dose Trivalent Inactivated Influenza Vaccine in Healthy Adults

It appears likely that there will be a delay and possibly a reduction in the amount of influenza vaccine available for the 2000-2001 influenza season. One possible way of increasing the availability of influenza vaccine for this year is to use a half-dose in healthy adults. The objective of this study is to determine if the immune system responds to a half-dose the same way it responds to a whole dose. This study will use the currently approved inactivated influenza vaccine in healthy adults ages 18 to 49 years old.

If the immune response to the half-dose is not significantly different than the immune response generated to the whole dose, this could be a strategy to extend the amount of vaccine that could be available in this age group.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: Approved influenza virus vaccine.

Detailed Description

Eligible subjects will be randomized to receive a single intramuscular injection of either a half-dose or a whole dose of a currently approved influenza virus vaccine in their arm. Prior to vaccination, subjects will have one tube of blood drawn. Subjects will be given a 3-day diary card to record any symptoms they may experience and asked to return for a second and final visit approximately 21 days following vaccination. A second blood draw will be done.

• Study Type: Interventional
• Enrollment: 840
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Torrance, California, United States, 90502
      • UCLA Center for Vaccine Research
  • Maryland
    • College Park, Maryland, United States
      • Maryland CARES
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Center for Vaccine Development
  • New York
    • Rochester, New York, United States, 14642
      • Univ of Rochester Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45206
      • Inf Dis Clinic at Gamble Research Clinic and Bethesda Hosp
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Volunteers may be eligible for this trial if they:

• Are able to and have given informed consent.
• Are able to understand and comply with all study procedures and to complete study diary.
• Are aged 18 to 49 years.
• Are female, and are not pregnant.
• Are available for all study visits.

Exclusion Criteria:

Volunteers will not be eligible for this trial if they:

• Are allergic to eggs or egg products.
• Have a current chronic medical condition for which influenza vaccine is normally recommended.
• Have received experimental vaccines or medications within 30 days of study entry.
• Have received parenteral immunoglobulin within 30 days of study entry.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention

Collaborators and Investigators

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: John Treanor, Univ of Rochester Medical Center

Study record dates

Study Major Dates

• Study Start: August 1, 2000
• Study Completion: September 1, 2000

Study Registration Dates

• First Submitted: August 7, 2000
• First Submitted That Met QC Criteria: August 30, 2001
• First Posted (Estimate): August 31, 2001

Study Record Updates

• Last Update Posted (Estimate): August 27, 2010
• Last Update Submitted That Met QC Criteria: August 26, 2010
• Last Verified: November 1, 2005

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: DMID 00-009