EUCTR2009-012385-31-PL
Active, not recruiting
Not Applicable
A Phase II, Randomized, Controlled, Double-blind, Multi-center, Study to Evaluate Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, of Two Monovalent H5N1 (Surface Antigen Adjuvanted with MF59C.1) Influenza Vaccines Containing 3.75 mcg or 7.5 mcg of H5N1 Influenza Antigen, in Non-elderly Adult and Elderly Subjects - Dose reduction
ovartis Vaccines and Diagnostics S.r.l.0 sites770 target enrollmentJuly 9, 2009
ConditionsAvian influenza
DrugsFOCETRIA
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Avian influenza
- Sponsor
- ovartis Vaccines and Diagnostics S.r.l.
- Enrollment
- 770
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Males and females 18 yrs of age and above on the day of enrollment.
- •2\.Individuals in good health as determined by medical history, physical examination and clinical judgment of the investigator
- •3\.Documented consent obtained after the nature of the study has been explained according to local regulatory requirements
- •4\.Individuals are able to comply with all study procedures and are available for all clinic visits scheduled in 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
Exclusion Criteria
- •1\.Individuals who are not able to comprehend and to follow all required study procedures for the whole period of the study or who do not consent to the retention of the subject’s serum samples after study completion.
- •2\.Individuals who have had influenza vaccine or documented suspected influenza disease within the past 6 months.
- •3\.Individuals Experienced any acute disease or infection requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) within the past 6 days;
- •4\.Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study
- •5\.Individuals with history or any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study
- •6\.History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to influenza viral proteins, to any excipients, and to eggs (including ovalbumin), chicken protein.
- •7\.History of any serious disease, such as:
- •b.history of serious chronic diseases (cardiac, renal, hepatic, metabolic (including diabetes mellitus), rheumatologic (including autoimmune disease such as rheumatoid arthritis), neurologic (including history of atypical febrile seizure or history of Guillain\-Barré disease), and hematologic (including bleeding diathesis))
- •c.history of underlying medical condition such as major congenital abnormalities requiring surgery, chronic treatment, or associated with developmental delay (e.g., Down’s syndrome)
- •8\.Known or suspected impairment/alteration of immune function, including:
Outcomes
Primary Outcomes
Not specified
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