Active immunoprofilaxis against potential pandemic influenza strain. MedDRA version: 9.1 Level: LLT Classification code 10059429 Term: Influenza immunisation
Conditions
Interventions
Product Name: Pandemic influenza vaccine adjuvanted with MF59C.1 (Fluad like- H5N1)
Pharmaceutical Form: Suspension for injection
Other descriptive name: Pandemic influenza vaccine adjuvanted with MF5
Sponsors
NOVARTIS VACCINES AND DIAGNOSTICS S.R.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female volunteers 18 years of age or older, mentally competent, willing and able to give written informed consent prior to study entry 2. Previously participating in study V87P1, but did not receive the booster dose on day 202 3. Able to comply with all the study requirements 4. In general good health as determined by: a. Medical history b. Physical examination c. Clinical judgment of the investigator 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. Any serious disease such as: a. Cancer (except for benign or localized skin cancer and non metastatic prostate cancer not presently treated with chemotherapy) b. Autoimmune disease (including rheumatoid arthritis) c. Advanced atherosclerotic disease or complicated diabetes mellitus d. Chronic obstructive pulmonary disease (COPD) that requires oxygen therapy e. Acute or progressive hepatic disease f. Acute or progressive renal disease g. Congestive heart failure 2. Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine 3. History of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine 4. Known or suspected (or have a high risk of developing) impairment/ alteration of immune function (excluding that normally associated with advanced age) resulting, for example, from: a. Receipt of immunosuppressive therapy (any parenteral or oral corticosteroid or cancer chemotherapy/radiotherapy) within the past 60 days and for the full length of the study b. Receipt of immunostimulants c. Receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months d. Suspected or known HIV infection or HIV-related disease 5. All females of childbearing potential who refuse to use an acceptable method of birth control for 21 days after the booster vaccination and/or who refuse to perform a urine pregnancy test prior to vaccination. 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 6. Pregnant or breastfeeding 7. Receipt of another vaccine or any investigational agent within the past 4 weeks 8. Experience of any acute disease or infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) within the past 7 days 9. Experience of fever (i.e., axillary temperature 38?C) within the past 3 days 10. Participation in another clinical study 11. Surgery planned during the study period 12. Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objective
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To assess persistence of antibody titers 17-18 months after primary immunization with two 0.5mL intramuscular (IM) doses of FLUAD-H5N1 influenza vaccine containing either 7.5?g or 15?g of H5N1 influenza antigen, as measured by Hemagglutination Inhibition (HI), Single Radial Hemolysis (SRH), and Microneutralization (MN) test. 2. To evaluate the safety of the administration of one 0.5mL IM booster dose of FLUADH5N1 influenza vaccine containing 7.5?g of H5N1 influenza antigen 17-18 months after primary immunization.;Secondary Objective: 1. To assess immunogenicity of one 0.5mL IM booster dose of FLUAD-H5N1 influenza vaccine containing 7.5?g of H5N1 influenza antigen (A/Turkey/Turkey), as measured by HI and SRH test in compliance with the requirements of the current European Union recommendations (CPMP/BWP/214/96). 2. To assess immunogenicity of one 0.5mL IM booster dose of FLUAD-H5N1 influenza vaccine containing 7.5 ?g of H5N1 influenza antigen, as measured by MN test.;Primary end point(s): The measures of immunogenicity, collected for all evaluable subjects include: - Geometric mean titers/areas (GMTs/GMAs) on days 382, 389, and 403 and GMRs for days 389 and 403 versus Day 382 as determined by HI, SRH, and MN. - Percentage of subjects achieving seroconversion1 or significant increase in antibody titer/area2 on days 389, and 403 as measured by HI and SRH. - Percentage of subjects with titers 20, titers 40, titers 80, on days 382, 389 and 403 and percentage of subjects with at least a four-fold rise in titer on days 389 and403 as determined by MN. - Percentage of subjects achieving a titer 40/ area 25 mm2 on days 382, 389, and 403 as determined by HI and SRH. | — |
Countries
Italy
Outcome results
None listed