Half-Dose Flu Vaccine Study in Healthy Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006146
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : August 27, 2010
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:

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 or disease Intervention/treatment Phase
Influenza Biological: Approved influenza virus vaccine. Phase 2

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  (Clinical Trial)
Enrollment : 840 participants
Primary Purpose: Prevention
Official Title: Evaluation of the Immunogenicity of Low Dose Trivalent Inactivated Influenza Vaccine in Healthy Adults
Study Start Date : August 2000
Study Completion Date : September 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00006146

United States, California
UCLA Center for Vaccine Research
Torrance, California, United States, 90502
United States, Maryland
Maryland CARES
College Park, Maryland, United States
United States, Missouri
Center for Vaccine Development
St Louis, Missouri, United States, 63110
United States, New York
Univ of Rochester Medical Center
Rochester, New York, United States, 14642
United States, Ohio
Inf Dis Clinic at Gamble Research Clinic and Bethesda Hosp
Cincinnati, Ohio, United States, 45206
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: John Treanor Univ of Rochester Medical Center Identifier: NCT00006146     History of Changes
Other Study ID Numbers: DMID 00-009
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: August 27, 2010
Last Verified: November 2005

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs