Half-Dose Flu Vaccine Study in Healthy Adults

Completed · Phase 2

Conditions studied: Influenza

In brief

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.

Key facts

Study ID

NCT00006146

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

840

Starts

2000-08-01

Expected to finish

2000-09-01

Last updated by the study team

2010-08-27

Who can join

Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UCLA Center for Vaccine Research — Torrance, California, United States
• Maryland CARES — College Park, Maryland, United States
• Center for Vaccine Development — St Louis, Missouri, United States
• Univ of Rochester Medical Center — Rochester, New York, United States
• Inf Dis Clinic at Gamble Research Clinic and Bethesda Hosp — Cincinnati, Ohio, United States
• Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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