Half-Dose Flu Vaccine Study in Healthy Adults
Half-Dose Flu Vaccine Study in Healthy Adults
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.
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.
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.