Clinical Trial: Half-Dose Flu Vaccine Study in Healthy Adults

This study is no longer recruiting patients.

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

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.

Condition Treatment or Intervention Phase
Influenza
 Vaccine: Approved influenza virus vaccine.
Phase II

MedlinePlus related topics:  Influenza

Study Type: Interventional
Study Design: Prevention

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

Further Study Details: 

Expected Total Enrollment:  840

Study start: August 2000;  Study completion: September 2000

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.

Eligibility

Ages Eligible for Study:  18 Years   -   49 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

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.

Location Information


California
      UCLA Center for Vaccine Research, Torrance,  California,  90502,  United States

Maryland
      Maryland CARES, College Park,  Maryland,  United States

Missouri
      Center for Vaccine Development, St. Louis,  Missouri,  63110,  United States

New York
      Univ of Rochester Medical Center, Rochester,  New York,  14642,  United States

Ohio
      Inf Dis Clinic at Gamble Research Clinic and Bethesda Hosp, Cincinnati,  Ohio,  45206,  United States

Texas
      Baylor College of Medicine, Houston,  Texas,  77030,  United States

Study chairs or principal investigators

John Treanor,  Principal Investigator,  Univ of Rochester Medical Center   

More Information

Study ID Numbers:  DMID 00-009
Record last reviewed:  August 2000
Last Updated:  October 13, 2004
Record first received:  August 7, 2000
ClinicalTrials.gov Identifier:  NCT00006146
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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