Single-blind, Dose-ranging Study of Novel Swine Influenza Virus Vaccine in Japanese Pediatric Subjects

• Conditions: Prophylaxis of A (H1N1) 2009 Swine Origin Pandemic Influenza; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2014-005075-88-Outside-EU/EEA
• Lead Sponsor: ovartis Pharma K.K

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-15
• Last Update Posted: 6 January 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Japanese males and females 6 months of age to 19 years of age on the day of informed consent;
2. Individuals in good health as determined by the outcome of medical history; physical examination and clinical judgment of the investigator;
3. Subjects, subject's parents or legal guardians that are able to comply with all study procedures and subjects are available for all clinic visits scheduled in the study;
4. 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 requirements able to comply with all study procedures and requirements.
Are the trial subjects under 18? yes
Number of subjects for this age range: 120
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. Individuals with history or any illness that, in the opinion of the investigator, pose additional risk to the subjects due to participation in the study;
2. Individuals with any serious chronic or progressive disease according to judgment of the investigator (including, but not limited to neoplasm, insulin dependentdiabetes, cardiac, renal or hepatic disease);
3. History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to influenza viral proteins, to any excipients;
4. Individuals who have had adjuvanted influenza vaccine or documented confirmed or suspected influenza disease* within 3 months prior to day 1.
* Laboratory-confirmed” includes:
a. Positive serology result
b. Positive viral culture
c. Positive rapid antigen test
Suspected” influenza disease includes: subjects with influenza-like illness, such as systemic symptoms (high fever, headache, arthralgia, etc.) and/or respiratory symptoms (sore throat, nasal discharge, caugh, etc.) within the past 3 months with a household/intimate contact with laboratory-confirmed” influenza disease.
5. 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;
6. Individuals 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 1 week prior to and after 1 week study vaccinations
7. Individuals with axillary temperature = 37.5 degrees Celsius or oral/rectal temperature = 38.0 degrees Celsius within 3 days of intended study vaccination;
8. 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 12 weeks prior to Visit 1 or planned during the full length of the study,
e. known HIV infection or HIV-related disease;
9. History of progressive or severe neurologic disorder (including Guillain-Barré syndrome and convulsions, but excluding febrile convulsions);
10. Height or weight is above +2SD or below -2SD compared to standard curve (Report on development of infants in 2000, and Report on servey of school health in 2000)
11. Bleeding diathesis;
12. Surgery planned during the study period that in the Investigator’s opinion would interfere with the study visits schedule;
13. 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 defined as one or more of the following:
i. Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring)
i

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified