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Half-Dose Flu Vaccine Study in Healthy Adults

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00006146
First received: August 7, 2000
Last updated: August 26, 2010
Last verified: November 2005
  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 2

Study Type: Interventional
Study Design: Primary Purpose: Prevention
Official Title: Evaluation of the Immunogenicity of Low Dose Trivalent Inactivated Influenza Vaccine in Healthy Adults

Resource links provided by NLM:


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
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, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: John Treanor Univ of Rochester Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00006146     History of Changes
Other Study ID Numbers: DMID 00-009
Study First Received: August 7, 2000
Last Updated: August 26, 2010
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014