Evaluate the Immunogenicity, Tolerability and Safety of a MF59-Adjuvanted, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Subjects Aged 18 Years and Above MedDRA version: 12.0 Level: LLT Classification code 10022000 Term: Influenza
Conditions
Interventions
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Influenza, purified antigen
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 7.5-
Trade Name: AGRIP
Sponsors
NOVARTIS VACCINES AND DIAGNOSTICS S.R.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. For study Groups A and B : Males and females aged 18 years and above on the day of enrollment, who took part to the Agrippal S1 or Fluad trials (V71_10S and V70_9S, respectively) for the 2009/10 vaccine registration; For study Groups C to E: Males and females aged 18 years and above on the day of enrollment, not yet exposed to the current seasonal formulation (2009/10 for NH) of the influenza vaccines; 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. 5. Willingness to allow for serum samples to be stored beyond the study period, for potential additional future testing to better characterize immune response. 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 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; 3. 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; 4. Individuals who have had received an influenza vaccine for the 2009/10 NH influenza season (for subjects to be included in Groups C to E only) prior to Visit 1; 5. Individuals who have had documented confirmed or suspected influenza disease within 6 months prior to Day 1. 6. Receipt of another investigational agent within 4 weeks prior to enrollment, or before completion of the safety follow-up period in this or in another study; unwilling to refuse participation in another clinical study through the end of this study; 7. Individuals who received any other vaccines within 4 weeks prior to enrollment in this study or who are planning to receive any vaccine within 4 weeks from the study vaccines; 8. Individuals who have ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks; 9. Individuals with axillary temperature ≥ 38.0 degrees Celsius (≥ 38.5C, if measured orally or rectally) within 3 days of intended study vaccination; 10. Known or suspected impairment/alteration of immune function, for example resulting from: a. receipt of immunosuppressive therapy such as systemic corticosteroids known to be associated with the suppression of hypothalamic-pituitary-adrenal (HPA) axis (15 mg/day of prednisone or its equivalent) or chronic use of inhaled high-potency corticosteroids (e.g. budesonide 800?g/day or fluticasone 750?g/day) within 60 days prior to Visit 1, b. cancer chemotherapy, c. receipt of immunostimulants within 60 days prior to Visit 1, d. receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months prior to Visit 1 or planned during the full length of the study, e. known HIV infection or HIV-related disease; 11. History of progressive or severe neurological disorders (including Guillain-Barre` syndrome and convulsions, but excluding febrile convulsions); 12. History of or clinically suspected developmental delay 13. Bleeding diathesis;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the immunogenicity of one and two intramuscular (IM) injections of the MF59-adjuvanted H1N1sw monovalent influenza vaccine in adult and elderly subjects previously exposed to 2009/10 NH formulation of TIV and in those not yet vaccinated against seasonal influenza 2009/10, with respect to CHMP criteria. To evaluate immunogenicity of one and two IM injections of full and half dose of a H1N1sw monovalent influenza vaccine concomitantly administered with a single IM dose of a seasonal TIV in adult subjects not yet vaccinated against seasonal influenza 2009/10, with respect to CHMP criteria. To evaluate immunogenicity of a single IM injection of a seasonal TIV when concomitantly administered with one and two IM injections of full and half dose of a H1N1sw monovalent influenza vaccine in adult subjects not yet vaccinated against seasonal influenza 2009/10, with respect to CHMP criteria.;Secondary Objective: ;Primary end point(s): Immunogenicity Endpoints The measures for immunogenicity as determined by HI are as follows: 1. Geometric mean HI titer (GMT) on Day 1, Day 22, Day 29 and Day 43 2. Day 22/Day1, Day 29/Day1, Day 43/Day 1, Day 29/Day 22, and Day 43/Day 22, geometric mean ratio (GMR) of HI; 3. Percentage of subjects achieving a seroconversion or a significant increase (defined as: HI ≥1:40 for subjects negative at baseline [ 40% The percentage of subjects achieving an HI titer ≥40 is > 70%. The GMR is >2.5 For elderly subjects aged ≥61 years: The percentage of subjects with seroconversion or at significant increase in HI antibody is > 30% The percentage of subjects achieving an HI titer ≥40 is > 60%. The GMR is >2.0 All three criteria should be met in each age group to fulfill regulatory requirements. For the trivalent seasonal vaccine, the immunogenicity criteria for success, as determined by HI, related to the CHMP/BWP/214/96 guideline, are the same as listed abov | — |
Countries
Italy
Outcome results
None listed