A phase II study, performed over a period of approximately 20 months,at one study site in Colombia in a population of subjects 18 to 40 years of age. Its aim was to evaluate the immunogenicity, safety and tolerability of H5N1adjuvanted vaccine given either sequentially, concomitantly or usingextemporaneous mixing with a seasonal trivalent influenza vaccine (Agrippal).

• Conditions: Influenza; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2014-004515-37-Outside-EU/EEA
• Lead Sponsor: ovartis Vaccines and Diagnostics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-21
• Last Update Posted: 27 October 2014

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Subjects aged 18 to 40 years of age who were mentally competent and who signed an informed consent form after having received a detailed explanation of the study protocol;
2. Subjects who were in good health as determined by:
? Medical history,
? Physical examination,
? Clinical judgment of the Investigator;
3. Subjects who were able to understand and comply with all study procedures and to complete study diaries, can be contacted, and will be available for study visits;
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 405
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Who received another investigational agent within 4 weeks, or before completion of the safety follow-up period in another study, whichever was longer, prior to enrollment and were unwilling to refuse participation in another clinical study through the end of the study;
2. Who received influenza vaccination for current season 2007;
3. Who experienced any acute disease or infection requiring systemic antibiotic or antiviral therapy within the past 7 days;
4. Who experienced fever (defined as axillary temperature =38.0°C) within 3 days prior to Visit 1;
5. Who were Pregnant or breastfeeding;
6. Females who refused to use an acceptable method of birth control for the duration of the study.
7. Who had 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;
8. Who had surgery planned during the study period;
9. Who had bleeding diathesis;
10. Who had hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the study vaccine;
11. Who had history of any neurological symptoms or signs, or anaphylactic shock following administration of any vaccine;
12. Who had 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. High risk for developing an immunocompromising disease;
13. Who had received another vaccine within 3 weeks prior and following each study vaccination;
14. Who had history of (or current) drug or alcohol abuse that in the investigator’s opinion would interfere with safety of the subject or the evaluation of study objectives;
15. Who had 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