Half-Dose Flu Vaccine Study in Healthy Adults
Evaluation of the Immunogenicity of Low Dose Trivalent Inactivated Influenza Vaccine in Healthy Adults
1 other identifier
interventional
840
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2000
Shorter than P25 for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2000
CompletedFirst Submitted
Initial submission to the registry
August 7, 2000
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2000
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedAugust 27, 2010
November 1, 2005
August 7, 2000
August 26, 2010
Conditions
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
UCLA Center for Vaccine Research
Torrance, California, 90502, United States
Maryland CARES
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John Treanor
Univ of Rochester Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Purpose
- PREVENTION
- Sponsor Type
- NIH
Study Record Dates
First Submitted
August 7, 2000
First Posted
August 31, 2001
Study Start
August 1, 2000
Study Completion
September 1, 2000
Last Updated
August 27, 2010
Record last verified: 2005-11