Half-Dose Flu Vaccine Study in Healthy Adults

Phase 2

Completed

• Conditions: Influenza

• Registration Number: NCT00006146
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2000-08
• Study First Submitted: 2000-08-07
• Study Completion: 2000-09
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Status Verified: 2005-11
• Last Update Submitted: 2010-08-26
• Last Update Posted: 2010-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 840

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (6)

UCLA Center for Vaccine Research; 🇺🇸 Torrance, California, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

Center for Vaccine Development; 🇺🇸 St Louis, Missouri, United States

Maryland CARES; 🇺🇸 College Park, Maryland, United States

Inf Dis Clinic at Gamble Research Clinic and Bethesda Hosp; 🇺🇸 Cincinnati, Ohio, United States

Univ of Rochester Medical Center; 🇺🇸 Rochester, New York, United States