|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00006146 |
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 II |
| MedlinePlus related topics: | Flu |
| Drug Information available for: | Influenza Vaccines Fluvirin |
| Study Type: | Interventional |
| Study Design: | Prevention |
| Official Title: | Evaluation of the Immunogenicity of Low Dose Trivalent Inactivated Influenza Vaccine in Healthy Adults |
| Estimated Enrollment: | 840 |
| Study Start Date: | August 2000 |
| Estimated Study Completion Date: | September 2000 |
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 |
Inclusion Criteria:
Volunteers may be eligible for this trial if they:
Exclusion Criteria:
Volunteers will not be eligible for this trial if they:
Contacts and 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 | |||||
| Principal Investigator: | John Treanor | Univ of Rochester Medical Center |
More Information
| Study ID Numbers: | DMID 00-009 |
| First Received: | August 7, 2000 |
| Last Updated: | November 11, 2005 |
| ClinicalTrials.gov Identifier: | NCT00006146 |
| Health Authority: | United States: Federal Government |
|
|
|