H5 Adult - Aventis Influenza A/H5N1 Vaccine in Healthy Adults - Article Avian flu; Bird flu; Bird flu (avian influenza); H5N1
Clinical Trial: H5 Adult - Aventis Influenza A/H5N1 Vaccine in Healthy Adults
This study is no longer recruiting patients.
The purposes of this study are:
- To determine the dose-related safety of flu vaccine in healthy adults;
- To determine the dose-related effectiveness of flu vaccine in healthy adults approximately 1 month following receipt of 2 doses of vaccine;
- To provide information for the selection of the best dose levels of vaccine for further studies.
|Influenza || Vaccine: Influenza A/H5N1 Vaccine ||Phase I |
MedlinePlus related topics: Influenza
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized, Double-Blinded, Placebo-Controlled, Phase I/II, Dose-Ranging Study of the Safety, Reactogenicity, and Immunogenicity of Intramuscular Inactivated Influenza A/H5N1 Vaccine in Healthy Adults
Expected Total Enrollment: 450
Study completion: October 2005
Accepts Healthy Volunteers
Subjects must meet all of the following inclusion criteria to participate in this study:
- Male or nonpregnant female (as indicated by a negative urine pregnancy test immediately prior to vaccine administration) between the ages of 18 and 64 years, inclusive.
- Women of childbearing potential who are at risk of becoming pregnant must agree to practice adequate contraception (ie, barrier method, abstinence, and licensed hormonal methods) for the entire study period.
- Is in good health, as determined by vital signs (heart rate, blood pressure, oral temperature), medical history and a targeted physical examination based on medical history.
- In Stage I subjects, should have normal laboratory values of Hgb, WBC, Plt, ALT, and creatinine prior to the first immunization.
- Able to understand and comply with planned study procedures.
- Provides informed consent prior to any study procedures and is available for all study visits.
Subjects who meet any of the following exclusion criteria at baseline will be excluded from study participation:
- Has a known allergy to eggs or other components of the vaccine.
- Has a positive urine pregnancy test prior to vaccination (if female of childbearing potential) or women who are breastfeeding.
- 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 µg/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 100.4ºF, within 1 week of vaccination.
- Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to enrollment in this study, or expects to receive an experimental agent during the 7-month study period.
- Has any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
UCLA Center For Vaccine Research, Torrance, California, 90502, United States
University of Maryland School of Medicine, Baltimore, Maryland, 21201, United States
University of Rochester - Rochester NY (VTEU), Rochester, New York, 14642, United States
University of Rochester School of Medicine and Dentistry, Rochester, New York, 14642, United States
University of Rochester Med. Ctr., Rochester, New York, 14642, United States
Last Updated: August 1, 2005
Record first received: June 26, 2005
ClinicalTrials.gov Identifier: NCT00115986
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-02