Half-Dose Flu Vaccine Study in Healthy Adults - Full Text View

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	Intervention	Phase
Influenza	Biological: Approved influenza virus vaccine.	Phase II

MedlinePlus related topics:

Flu

Drug Information available for:

Influenza Vaccines Fluvirin

U.S. FDA Resources

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

Estimated Enrollment:	840
Study Start Date:	August 2000
Estimated Study Completion Date:	September 2000

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.

Eligibility

Ages Eligible for Study:	18 Years to 49 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006146

Locations


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)

Investigators


Principal Investigator:	John Treanor	Univ of Rochester Medical Center

More Information

Study ID Numbers:	DMID 00-009
First Received:	August 7, 2000
Last Updated:	November 11, 2005
ClinicalTrials.gov Identifier:	NCT00006146
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Virus Diseases

Respiratory Tract Diseases

Respiratory Tract Infections

Influenza, Human

Healthy

Orthomyxoviridae Infections

Additional relevant MeSH terms:

RNA Virus Infections

ClinicalTrials.gov processed this record on December 03, 2008

Sponsored by:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00006146