A Randomized, Single-blind, Dose-Ranging Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted and non-Adjuvanted Egg-derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Subjects from 6 Months to 17 Years of Age

Phase 1

Conditions: Pandemic influenza

Registration Number: EUCTR2009-013672-45-BE

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: 720

Inclusion Criteria

1. Males and females 6 months of age to 17 years of age on the day of enrollment;
2. Subject's parents or legal guardians who have given written consent and the subjects has given assent consent, if applicable, after the nature of the study has been explained according to local regulatory requirementsable to comply with all study procedures and requirements;
3. Individuals in good health as determined by the outcome of medical history; physical examination and clinical judgment of the investigator;
4. Subjects, subject's parents or legal guardians that 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? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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

1. Subject's parents or legal guardians 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 (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),
chicken protein;
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 a participation in another clinical study through the end of this study;
7. Individuals who receive any other vaccine 4 weeks prior to enrolment in this study
or who are planning to receive any vaccine within four weeks from the study vaccines; the only exception being plain seasonal influenza vaccines which are allowed until one week prior to and after one week for the first two study vaccinations. Individuals who have received any influenza vaccine for the 2010 /
2011 season or for the 2010 Southern Hemisphere season less than 8 months
before the booster dose. Individuals who have received the monovalent H1N1
pandemic vaccine outside this protocol less that 8 months before the booster dose;
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 = 38.0 degrees Celsius (=100.4 F) or
oral/rectal temperature = 38.5 degrees Celsius (=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-pituitaryadrenal (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 neurologic disorder (including Guillain-Barré
syndrome, and convulsion, but excluding febrile convulsion);
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 capable of becoming pregnant and not surgically sterile
b. Acceptable birth control methods are defi

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