A Phase II, Randomized, Controlled, Observer-blind, Single-center Study to Evaluate the Immunogenicity, Safety and Tolerability of Two Doses of FLUAD-H5N1 Influenza Vaccine in Subjects aged 6 months to 17 years

Active, not recruiting

• Conditions: avian influenza; MedDRA version: 9.1Level: LLTClassification code 10064097Term: Avian influenza

• Registration Number: EUCTR2007-002480-27-FI
• Lead Sponsor: ovartis Vaccines and Diagnostics GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-20
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Female or male subjects aged 6 months to <18 years whose parents/legal guardians have signed an informed consent form after having received a detailed explanation of the study protocol. Subjects from 9 to <18 years of age additionally have to sign an assent form having received a detailed explanation of the study protocol.
2. 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, can be contacted, and will be available for all study visits
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. Participation in another clinical study at the same time or within the last 3 months and unwilling to refuse participation in another clinical study through the end of this study;
2. Previous vaccination with a pandemic candidate vaccine and/or vaccine containing the adjuvant MF59 or a similar adjuvant;
3. Receipt of influenza vaccination for the current season 2007/2008;
4. Receipt of another vaccine within 3 weeks before and after each study vaccination;
5. Any acute disease or infection requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) within the past 7 days;
6. Fever (defined as axillary temperature =38.0°C) within 3 days prior to Visit 1,
7. Pregnant or breastfeeding;
8. Females of childbearing potential (i.e., after first menstrual bleeding until 2 years after last menstrual bleeding, except females with hysterectomy or abstinent females) who refuse to use an acceptable method of birth control for the duration of the study and who refuse to perform a urine pregnancy test prior to vaccination. Adequate contraception is defined as hormonal (e.g., oral, injection, transdermal patch, implant, cervical ring), barrier (e.g., condom with spermicide or diaphragm with spermicide), intrauterine device (e.g., IUD), or monogamous relationship with a vasectomized partner who has been vasectomized for 6 months or more prior to the subject’s study entry;
9. Any serious disease, such as:
a. Cancer,
b. Autoimmune disease (including rheumatoid arthritis),
c. Diabetes mellitus,
d. Asthma, chronic pulmonary disease (steroids administered by inhalation only or clinical symptoms less frequent than once a day are acceptable),
e. Acute or progressive hepatic disease,
f. Acute or progressive renal disease;
10. Known or suspected impairment/alteration of immune function, for example, resulting from:
a. Receipt of immunosuppressive therapy (corticosteroid -except topical or inhaled steroids- or cancer chemotherapy, immunoglobulins), asthma under inhalation therapy only acceptable,
b. Receipt of immunostimulants,
c. Receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 3 months and for the full length of the study,
d. High risk for developing an immunocompromising disease;
11. Surgery planned during the study period;
12. Bleeding diathesis;
13. Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the study vaccine;
14. History of any neurological symptoms or signs, or anaphylactic shock following administration of any vaccine;
15. History of neurological disorder or seizures (febrile seizures allowed);
16. Children who are in the local recommendation for influenza vaccination;
17. 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;
18. 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