A Phase III, Randomized, Controlled, Observer-Blind, Multicenter Study to Evaluate the Immunogenicity, Safety and Tolerability of Two Doses of FLUAD-H5N1 Influenza Vaccine in Adult and Elderly Subjects
- Conditions
- avian influenza
- Registration Number
- EUCTR2006-005428-18-CZ
- Lead Sponsor
- ovartis Vaccines and Diagnostics GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 4400
1. Subjects 18 years of age and older who are mentally competent and who have signed an informed consent form after having received a detailed explanation of the study protocol;
2. In good health as determined by:
a. medical history,
b. physical examination,
c. clinical judgment of the Investigator;
3. Able to understand and comply with all study procedures and to complete study diaries, can be contacted, and will be available for study visits;
Informed consent must be obtained for all the subjects before enrollment into the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Receipt of another investigational agent within 4 weeks, or before completion of the safety follow-up period in another study, whichever is longer, prior to enrollment and unwilling to refuse participation in another clinical study through the end of the study.
2. Receipt of influenza vaccination for current season 2006/2007.
3. Experienced any acute disease or infection requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) within the past 7 days.
4. Experienced fever (defined as axillary temperature ³38.0°C) within 3 days (prior to Visit 1)
5. Pregnant or breastfeeding;
6. Females of childbearing potential who refuse to use an acceptable method of birth control for the duration of the study. Adequate contraception is defined as hormonal (e.g., oral, injection, transdermal patch, implant, cervical ring) barrier (e.g., condom with spermicide or diaphragm with spermicide) intrauterine device (e.g., IUD), or monogamous relationship with vasectomized partner who has been vasectomized for 6 months or more prior to the subject’s study entry
7. Any serious disease, such as:
a. cancer
b. autoimmune disease (including rheumatoid arthritis)
c. diabetes mellitus
d. chronic pulmonary disease
e. acute or progressive hepatic disease
f. acute or progressive renal disease
8. Surgery planned during the study period
9. Bleeding diathesis
10. Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the study vaccine
11. History of any neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
12. Known or suspected impairment/alteration of immune function, for example, resulting from:
a. receipt of immunosuppressive therapy (any corticosteroid therapy or cancer chemotherapy)
b. receipt of immunostimulant
c. high risk for developing an immunocompromising disease
13. Receipt of another vaccine within 3 weeks prior to Visit 1 or planned vaccination within 3 weeks following the last study vaccination
14. History of (or current) drug or alcohol abuse that in the investigator’s opinion would interfere with safety of the subject or the evaluation of study objectives
15. Any condition, which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method