An Open-Label Phase III Study to Assess the Safety and Immunogenicity of a Vero Cell-Derived Whole Virus H5N1 Influenza Vaccine in an Adult and Elderly Population as well as in Specified Risk Groups
- Conditions
- GriepH5N1-Influenzaavian flu
- Registration Number
- NL-OMON35419
- Lead Sponsor
- Baxter
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 500
-Are 18 years of age or older
-Agree to keep a daily record of symptoms for the duration of the study
-Are generally healthy, as determined by the investigator*s clinical judgment
through collection of medical history and performance of a physical
examination.
-Have a history of exposure to H5N1 virus or a history of vaccination with an
H5N1 influenza vaccine;
-Are at high risk of contracting H5N1 influenza infection
-Have a history of severe allergic reactions or anaphylaxis;
-Have a rash, dermatological condition or tattoos which may interfere with
injection site reaction rating;
-Have received any live vaccine within 4 weeks or inactivated vaccine within 2
weeks prior to vaccination in this study;
-Currently have or have a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Frequency and severity of systemic reactions after the first, second and<br /><br>third vaccinations.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Frequency and severity of injection site reactions after the first, second<br /><br>and third vaccinations;<br /><br>- Number of subjects with fever, malaise or shivering with onset within 7 days<br /><br>after the first, second and third vaccinations;<br /><br>- Frequency and severity of adverse events (AEs) observed during the entire<br /><br>study period.</p><br>