Status:
COMPLETED
Young Adult Influenza Vaccine Immunogenicity Substudy
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Influenza
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief Summary
This is a complimentary study to an elderly influenza study. Subjects 18-40 will receive a single dose flu vaccine and be evaluated for humoral and cell mediated immunity to influenza antigens.
Detailed Description
The goals of this study are to provide in depth humoral and cellular immune responses to the standard-dose trivalent SV influenza virus vaccine containing 15 pg HA of each virus strain in healthy youn...
Eligibility Criteria
Inclusion
- Male or nonpregnant female (as indicated by a negative urine pregnancy test immediately prior to vaccine administration) between the ages of 18 and 40 years, inclusive.
- Women of childbearing potential who are at risk of becoming pregnant must agree to practice adequate contraception (i.e., barrier method, abstinence, and licensed hormonal methods) for the entire study period (28 days).
- In good health, as determined by medical history and a targeted physical examination, if necessary.
- Able to understand and comply with planned study procedures.
- Able to provide informed consent and be available for all study visits.
Exclusion
- Has a known allergy to eggs or other components of the vaccine.
- Has a positive urine pregnancy test at screening or prior to vaccination (if female), is lactating, or has the intention to become pregnant within 3 months of enrollment in this study.
- Is undergoing immunosuppression as a result of an underlying illness or treatment.
- Has an active neoplastic disease or a history of any hematologic malignancy.
- Is using oral or parenteral steroids, high-dose inhaled steroids (\>800 mcg/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs.
- Has a history of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.
- Has received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study.
- Has an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses (this includes, but is not limited to: known chronic liver disease, significant renal disease, unstable or progressive neurological disorders, diabetes mellitus, and transplant recipients).
- Has a history of severe reactions following immunization with contemporary influenza virus vaccines.
- Has an acute illness, including an oral temperature greater than 100.4 degrees F, within one week of vaccination.
- Received an experimental vaccine or medication within 1 month prior to enrollment in this study, or expects to receive an experimental vaccine, medication, or blood product during the 4 week study period.
- Has any condition that would place the volunteer at an unacceptable risk of injury or any condition that in the opinion of the investigator may compromise the safety of the volunteer or integrity of the study.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2005
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00170508
Start Date
June 1 2005
End Date
August 1 2005
Last Update
August 23 2013
Active Locations (1)
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1
University of Maryland Baltimore
Baltimore, Maryland, United States, 21201