A Randomized, Single-blind, Dose-Ranging, Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of Adjuvanted and non Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Subjects 18 or More Years of Age

Conditions: Pandemic influenza

Registration Number: EUCTR2009-013671-21-NL

Lead Sponsor: ovartis Vaccines and Diagnostics S.r.l.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 600

Inclusion Criteria

1. Males and females 18 years of age and above on the day of enrollment;
2. Individuals in good health as determined by the outcome of medical history, physical assessment and clinical judgment of the investigator
3. Individuals are able to comply with all study procedures and are available for all clinic visits scheduled in the study
4. 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

1. Individuals who are not able to comprehend and to follow all required study procedures for the whole period of the study;
2. 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;
3. Individuals with any serious chronic or progressive disease according to judgment of the investigator (including, but not limited to 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.
5. Individuals who have had adjuvanted influenza vaccine or documented confirmed or suspected influenza disease within 3 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; the only exception being plain seasonal influenza vaccines which are allowed until 1 week prior to and after 1 week study vaccinations.
8. Individuals who have received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks;
9. Individuals with axillary temperature = 38 degrees Celsius (= 100.4° F) or oral temperature = 38.5 (=101.3° F) 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 800µg/day or fluticasone 750µg/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-Barré 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 visits schedule;
15. 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. Female of childbearing potential is defined as a post onset of menarche or pre-menopausal female capable of becoming pregnant. This does not include females who meet any of the following conditions: (1) menopause at least 2 years earlier, (2) tubal ligation at least 1 year earlier, or (3) total hysterectomy.
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 spermic

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method