Avian influenza
Conditions
Interventions
Trade Name: FOCETRIA
Product Name: Focetria
Pharmaceutical Form: Suspension for injection
Other descriptive name: A/Vietnam/1194/2004 (H5N1) - like strain (A/Vietnam/1194/2004 NIBRG-14)
Concentration
Sponsors
Novartis Vaccines and Diagnostics S.r.l.
Eligibility
Sex/Gender
All
Inclusion 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
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: a. cancer 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: a. Chronic use of oral steroids or any use of parenteral steroids within 60 days prior to Visit 1 (use of inhaled, intranasal, or topical corticosteroids is allowed). b. receipt of immunostimulants within 60 days prior to Visit 1 c. receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivates within 3 months prior to Visit 1 or planned during the full length of the study d. HIV infection or HIV-related disease e. Heritable immunodeficiency f. Abnormalities of splenic or thymic function 9. Pregnant or breast-feeding female 10. Any positive or indeterminate pregnancy test 11. If female, of childbearing potential, and has not used any of the “acceptable contraceptive methods” for at least 2 months prior to study entry a. Of childbearing potential is defined as status post onset of menarche and not surgically sterile b. Acceptable birth control methods are defined as one or more of the following: i. Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring) ii. Barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse iii. Intrauterine device (IUD) iv. Monogamous relationship with vasectomized partner. Partner must have been vasectomized for at least six months prior to the subject’s study entry 12. If female of childbearing potential, refusal to use an “acceptable contraceptive method” during the study including day 43. 13. If female of childbearing potential, refusal to submit for pregnancy testing prior to study vaccination 14. Laboratory-confirmed or suspected influenza disease within 6 months prior to Visit 1. “Laboratory-confirmed” includes: a. Positive serology result b. Positive viral culture c.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary To demonstrate the non-inferiority of antibody responses of two 0.5 mL intramuscular (IM) injections administered 3 weeks apart of a monovalent MF59-adjuvanted H5N1 pandemic vaccine containing 3.75µg H5N1 antigen dose to a pandemic vaccine containing a 7.5µg H5N1antigen dose in terms of post-immunization geometric mean titers (GMT) Co-Primary Once non-inferiority has been shown as determined by SRH, subsequently non-inferiority will be assessed as determined by HI test in a stepwise procedure, thus non-inferiority can be concluded if either non-inferiority can be shown for SRH only or if it can be shown for both SRH and HI;Secondary Objective: A. To evaluate the immunogenicity of two 0.5 mL intramuscular (IM) injections of a monovalent MF59-adjuvanted H5N1 pandemic vaccine containing 3.75µg H5N1 antigen dose and a pandemic vaccine containing a 7.5µg H5N1antigen dose according to CHMP criteria in terms of seroprotection, seroconversion and geometric mean ratio (CPMP/BWP/214/96) as determined by single radial hemolysis (SRH) in non-elderly adult and elderly subjects separately, for all post-vaccination blood sampling days B. To evaluate the immunogenicity according to CHMP criteria in terms of seroprotection, seroconversion and geometric mean ratio (CPMP/BWP/214/96) as determined by hemagglutination inhibition (HI) C. To evaluate the immunogenicity according to CBER criteria in terms of hemagglutination inhibition (HI) and microneutralization (MN) test D. To evaluate the immunogenicity as measured by microneutralization (MN) test ;Primary end point(s): ? Day 43 post vaccination ratio of GMTs for group A and B (3.75µ / 7.5µg) including 2-sided 95% confidence intervals as measured by HI and SRH in the adult and elderly population combined | — |
Countries
Poland
Outcome results
None listed