Safety and Immunogenicity of Two 0.25 mL or 0.5 mL Doses of Two Different Influenza Vaccines in Healthy Children Aged 6 to <60 Months.

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

• Registration Number: EUCTR2014-004543-12-Outside-EU/EEA
• Lead Sponsor: ovartis Vaccines and Diagnostics Srl.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-04
• Last Update Posted: 10 November 2014

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

1. Children of 6 to <60 months of age, whose parents/legal guardians have given written informed consent prior to study entry.
2. In good health as determined by:
a. medical history,
b. physical examination,
c. clinical judgment of the investigator.
3. Able to comply with all study procedures and available for all clinic visits and telephone calls scheduled in the study.
4.Informed consent was obtained for all the subjects before enrollment into the study after the nature of the study had been explained.
Are the trial subjects under 18? yes
Number of subjects for this age range: 360
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. 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,
g. acute or progressive neurological or neuromuscular disease;
2. History of any anaphylaxis or serious reaction following administration of vaccine, or hypersensitivity to eggs, egg protein, chicken feathers, influenza viral protein, or any other vaccine component, chemically related substance, or component of the potential packaging materials;
3. Known or suspected impairment/alteration of immune function, including:
a. immunosuppressive therapy such as systemic corticosteroids known to be associated with the suppression of hypothalamic-pituitary-adrenal (HPA) axis or chronic use of inhaled high-potency corticosteroids 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;
4. History of Guillain-Barré syndrome;
5. Bleeding diathesis;
6. Surgery planned during the study period;
7. 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 study;
8. Receipt of another vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to Visit 1;
9. Laboratory-confirmed influenza disease within 6 months prior to Visit 1;
10. Ever received two doses of an influenza vaccine before the study, either in two consecutive influenza seasons or in one single influenza season;
11. Receipt of an influenza vaccine within 6 months prior to Visit 1;
12. Experienced a temperature =38.0°C (=100.4°F ) and/or any acute illness within 3 days prior to Visit 1;
13. Any condition, which in the opinion of the Investigator would preclude the subject, on a medical basis, from enrollment or that might interfere with the evaluation of the study objectives.

Study & Design

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