Half-Dose Flu Vaccine Study in Healthy Adults
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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 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: 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:
- 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.
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
No publications provided
| ClinicalTrials.gov Identifier: | NCT00006146 History of Changes |
| Other Study ID Numbers: | DMID 00-009 |
| Study First Received: | August 7, 2000 |
| Last Updated: | August 26, 2010 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 22, 2013