Prophylaxis of A/H1N1sw influenza MedDRA version: 12.1 Level: LLT Classification code 10022001 Term: Influenza (epidemic)
Conditions
Interventions
Trade Name: FOCETRIA
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Influenza, purified antigen
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 7.
Sponsors
OPERA SRL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent obtained; 2. Males and females from 18 years to 60 years of age on the day of enrolment; 3. Subjects in good health as determined by the outcome of medical history, physical assessment and clinical judgment by the Investigator; 4. Subjects are able to comply with all study procedures and are available for all clinic visits scheduled in the study; 5. Willingness to allow for blood 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects who are not able to comprehend and to follow all required study procedures for the whole period of the study; 2. Subjects 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; 3. Subjects with any serious chronic or progressive disease according to judgment of the Investigator (including, but not limited to malignant neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease); 4. History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to influenza viral proteins, to any excipients, and to eggs (including ovalbumin), and chicken proteins; 5. Subjects who have had seasonal influenza vaccine or documented confirmed seasonal influenza disease within 2 weeks prior to Day 1; 6. Receipt of another investigational agent within 4 weeks prior to enrolment, or before completion of the safety follow-up period in this or in another study; subjects unwilling to refuse participation in another clinical study throughout the end of this study; 7. Subjects who received any other vaccines within 4 weeks prior to enrolment in this study or who are planning to receive any vaccine within 4 weeks from the study vaccines; the only exception being plain seasonal influenza vaccines which are allowed until 2 weeks before and over 2 weeks after the study vaccination; 8. Subjects who have received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks or plan to receive these products during the full length of the study; 9. Subjects with axillary temperature ≥ 38C (≥ 100.4F) or oral temperature ≥ 38.5C (≥ 101.3F) 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 (10 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 within 5 years, c. receipt of immunostimulants within 60 days prior to Visit 1, d. history of 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; 14. Surgery planned during the study period that in the Investigator s opinion would interfere with the study; 15. Female subjects who are pregnant or nursing (breastfeeding) mothers, or females of childbearing potential who are sexually active and have not used any of the acceptable contraceptive methods for the 2 months before entering the study or do not plan to use them up to the end of the study; 16. Members of the research staff who have direct access to any study documents containing subject information.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore the antibody and cell mediated immune (CMI) responses to one 0.50 mL IM injection of egg-derived Focetria pandemic influenza vaccine in terms of quality and quantity of the antigen-specific T- and B-cell response in healthy adults aged 18-60 years.;Secondary Objective: To explore the antibody responses to one injection of egg-derived Focetria pandemic influenza vaccine according to CHMP criteria in healthy adults aged 18-60 years. Although this study is not designed nor powered to draw conclusions regarding safety and tolerability (which are being evaluated in other ongoing studies), these variables will also be monitored in subjects receiving one IM injection of egg-derived Focetria pandemic influenza vaccine.;Primary end point(s): CMI endpoints will reflect frequencies and fold increases of antigen-specific CD4+ T cells (as determined by ICS/FACS analysis) and B lymphocytes (as determined by ELISpot or LDA-ELISA assay) eventually differentiated by their functional profile, at the relevant time points. Antibody responses to H1N1sw will be assessed on plasma samples obtained at days 1, 8, 22, and 202, by Hemagglutination Inhibition (HI) test, single radial haemolysis (SRH) and by microneutralization (MN). | — |
Countries
Italy
Outcome results
None listed