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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Approved influenza virus vaccine. | Biological |
Inclusion Criteria:
Volunteers may be eligible for this trial if they:
Exclusion Criteria:
Volunteers will not be eligible for this trial if they:
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| Name | Affiliation | Role |
|---|---|---|
| John Treanor | Univ of Rochester Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Center for Vaccine Research | Torrance | California | 90502 | United States | ||
| Maryland CARES |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| College Park |
| Maryland |
| United States |
| Center for Vaccine Development | St Louis | Missouri | 63110 | United States |
| Univ of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Inf Dis Clinic at Gamble Research Clinic and Bethesda Hosp | Cincinnati | Ohio | 45206 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |