Status:
COMPLETED
Inactivated Influenza A/H9N2 Vaccine With and Without MF59 Adjuvant in Ambulatory Adults
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Influenza
Eligibility:
All Genders
18-34 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to compare the body's reactions and immune responses after receiving different strengths of a H9N2 influenza virus vaccine with and without an adjuvant given into the arm ...
Detailed Description
The primary goal of this study is to assess the safety of 4 different dosages of purified monovalent surface antigen (SA) influenza A/H9N2 virus vaccine with or without MF59 adjuvant and administered ...
Eligibility Criteria
Inclusion
- Ambulatory, healthy males and non-pregnant female adults 18-34 years of age.
- Able to give informed consent and available for all study visits.
- Able to understand and comply with planned study procedures.
- Women capable of bearing children must utilize an acceptable means of birth control (abstinence, oral contraceptives ("the pill"), intrauterine devices (IUDs), contraceptive implants under the skin, or contraceptive injections, or condoms with foam).
- On no concomitant medications except contraceptive medications.
- Normal screening laboratory values.
Exclusion
- Known allergy to eggs or other components of vaccine.
- Prior receipt of an influenza A/H9N2 vaccine.
- Abnormal screening laboratory values (laboratory values must be within normal limits).
- Pregnancy, desire to become pregnant in the next 3 months, or lactation.
- Immunosuppression as a result of underlying illness or treatment.
- Use of oral or parenteral steroids, high-dose inhaled steroids (\>800 mcg per day of beclomethasone dipropionate or equivalent), other immunosuppressive or cytotoxic drugs.
- Active neoplastic disease or history of any hematologic malignancy.
- Acute or chronic condition that (in the opinion of the investigator) would render vaccination unsafe or would interfere with the evaluation of responses (including but not limited to the following: known chronic liver disease, significant renal disease, unstable or progressive neurologic disorder, diabetes mellitus, transplant recipient).
- Use of experimental vaccines or medications within the month prior to study entry, or expected use of experimental or licensed vaccines or blood/blood products during the 1 month period after each inoculation with study vaccine.
- Receipt of immunoglobulin or other blood product within 3 months prior to enrollment.
- Receipt of other licensed vaccines within the preceding 2 weeks (inactivated vaccines) or 4 weeks (live vaccines).
- History of a severe reaction following vaccination with a contemporary influenza vaccine.
- Subject is enrolled in another clinical trial.
- Study personnel (those persons identified on study personnel logs).
- Any condition that in the opinion of the investigator would interfere with the interpretation or evaluation of the vaccine.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00133471
Start Date
March 1 2005
End Date
December 1 2005
Last Update
August 27 2010
Active Locations (1)
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1
Baylor College of Medicine
Houston, Texas, United States, 77030