A Phase III, Randomized, Controlled, Observer-Blind, Multicenter Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Doses of a Monovalent A/H5N1 Influenza Vaccine Adjuvanted with MF59 (FLUAD-H5N1), in Adult and Elderly Subjects
- Conditions
- pandemic influenza
- Registration Number
- EUCTR2008-003871-32-FI
- Lead Sponsor
- ovartis Vaccines and Diagnostics S.r.l.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 3875
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;
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. Laboratory-confirmed influenza disease within 6 months prior to Visit 1;
3. Receipt of influenza vaccination for current season 2008/2009;
4. Experienced any acute disease or infection requiring systemic antibiotic or
antivira therapy (chronic antibiotic therapy for urinary tract prophylaxis is
acceptable) within the past 7 days;
5. Experienced fever (defined as axillary temperature >=38.0°C) within 7 days prior
to Visit 1;
6. Pregnant or breastfeeding;
7. Females of childbearing potential who are sexually active and have not used or do
not plan or refuse to use an acceptable method of birth control during the active
phase of the study (at least up to three weeks after last vaccine
injection). Adequate contraception method is defined as hormonal (e.g., oral,
injection, transdermal patch, implant, cervical ring), barrier (e.g., condom or
diaphragm with spermicidal agent), and intrauterine device (e.g., IUD);
8. Any serious disease, such as:
a. cancer except for:
i. benign or localized skin cancer
ii. localized prostate cancer that has been clinically stable for = 2
years without treatment
iii.cancer in remission for = 10 years
b. autoimmune disease (including rheumatoid arthritis) except for Hashimoto's
thyroiditis that has been clinically stable for = 5 years;
c. diabetes mellitus type I;
d. diabetes mellitus type II with haemoglobin A1C > 7.5%;
e. diabetes relating to genetic defects/syndromes, diseases of the exocrine
pancreas, or infections;
f.advanced arteriosclerotic disease including but not limited to: ischemic heart
disease (e.g., angina), prior history of myocardial infarction or cerebrovascular
accident (CVA), transient ischemic attacks, prior surgical/interventional
radiology intervention for arteriosclerotic disease (e.g., coronary artery
bypass graft, angioplasty, vascular stent placement, vascular graft
procedures), and claudication/rest pain;
g. severe chronic obstructive pulmonary disease (COPD), i.e. GOLD stages 3 and
4;
h. acute or progressive hepatic disease;
i. acute or progressive renal disease;
j. congestive heart failure;
k. Body Mass Index =35 kg/m2 where BMI reflects obesity and not high
muscle mass;
9. History of progressive or severe neurologic disorders including but not limited
to multiple sclerosis, Parkinson's disease, Guillain-Barré syndrome, amyotrophic
lateral sclerosis, Creutzfeldt-Jakob disease, epilepsy disorders requiring
medication for control, encephalitis, Alzheimer's and CVA;
10. Surgery planned during the study period;
11. Bleeding diathesis;
12. Hypersensitivity to eggs, chicken protein, chicken feathers, influenza
viral protein, neomycin or polymyxin or any other component of
the study vaccines;
13. History of any neurological symptoms or signs, or anaphylactic shock following
administration of any vaccine;
14. Known or suspected impairment/alteration of immune function, for
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