Safety, and Immunogenicity of Two Influenza Vaccines in Healthy Subjects 3 to 64 Years Old

• Conditions: Influenza; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2014-004757-14-Outside-EU/EEA
• Lead Sponsor: ovartis Vaccines and Diagnostics S.r.l.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-07
• Last Update Posted: 10 November 2014

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 1800

Inclusion Criteria

1. Subjects aged 3 to 8 years (age group 1), whose parents or legal guardians have given written informed consent prior to study entry

2. Subjects aged 9 to 17 years (age group 2) and 18 to 64 years (age group 3), able and willing to provide written informed consent prior to study entry

3. Available for all the visits and telephone call scheduled in the study

4. In good health as determined by:
a. medical history,
b. physical examination,
c. clinical judgment of the Investigator.
Are the trial subjects under 18? yes
Number of subjects for this age range: 1200
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 600
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Receipt of another investigational agent within 90 days, or before completion of the safety follow-up period in another study, whichever is longer, prior to enrollment and unwilling to refuse participation in another clinical study through the end of the present study

2. Any disease or infection, both requiring systemic antibiotic or antiviral therapy, within 30 days prior to Visit 1

3. Fever (defined as axillary temperature ??38.0°C) within 7 days prior to Visit 1

4. Pregnant or nursing mothers or females of childbearing potential who do not plan to use acceptable birth control measures during the three weeks following vaccination. Oral, injected, inserted or implanted hormonal contraceptive, diaphragm or condom with spermicidal agent or intrauterine device are considered acceptable forms of birth control

5. Any serious disease, such as:
a. cancer,
b. autoimmune disease (including rheumatoid arthritis),
c. diabetes mellitus,
d. chronic pulmonary disease,
e. acute or progressive hepatic disease,
f. acute or progressive renal disease

6. Surgery planned during the study period

7. Bleeding diathesis

8. History of hypersensitivity to any component of the study vaccine or chemically related substances

9. History of any anaphylaxis, serious vaccine reactions, or allergy to eggs, egg products, or any other vaccine component

10. Known or suspected impairment/alteration of immune function, for example, resulting from
a. receipt of immunosuppressive therapy (any corticosteroid therapy or cancer
chemotherapy),
b. receipt of immunostimulants,
c. 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,
d. high risk for developing an immunocompromising disease

11. Laboratory confirmed influenza disease within 6 months prior to Visit 1

12. Having ever received an influenza vaccine (for subjects aged 3 to 8 years only)

13. Receipt of another vaccine within 30 days prior to Visit 1 or planned vaccination within 3 weeks following the last study vaccination

14. Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.

Study & Design

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