A Phase II, Open-label, multi center Study to Evaluate the Immunogenicity, Safety and Tolerability of Two Doses of FLUAD-H5N1 Influenza Vaccine in Adult and Elderly Subjects
- Conditions
- The present study is therefore designed to evaluate the immunogenicity, safety and tolerability of two doses of FLUAD-H5N1 vaccine containing A/H5N1/turkey/Turkey/05 administered 3 weeks apart in non-elderly adult and elderly subjects.
- Registration Number
- EUCTR2008-000895-25-HU
- Lead Sponsor
- ovartis Vaccines and Diagnostics GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 334
1.Subjects aged 18 years of age and older who are mentally competent and who have signed an informed consent form after having received a detailed explanation of the study protocol;
2.In good health as determined by:
a.Medical history,
b.Physical examination,
c.Clinical judgment of the Investigator;
3.Able to understand and comply with all study procedures and to complete study diaries, can be contacted, and will be available for all study visits.
Informed consent must be obtained for all the subjects before enrollment into the study.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1.Previous receipt of any H5 vaccine;
2.Receipt of another investigational agent within 4 weeks, 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;
3.Experienced 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;
4.Experienced fever (defined as axillary temperature ?38.0°C) within 3 days prior to Visit 1;
5.Pregnant or breastfeeding;
6.Females of childbearing potential who refuse to use an acceptable method of birth control for the duration of the study. 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 vasectomized partner who has been vasectomized for 6 months or more prior to the subject’s study entry;
7.Any serious disease, such as:
a.Medically significant cancer,
b.Autoimmune disease (including rheumatoid arthritis and diabetes mellitus type 1),
c.Medically significant diabetes mellitus type 2,
d.Medically significant chronic pulmonary disease,
e.Medically significant acute or progressive hepatic disease,
f.Medically significant acute or progressive renal disease;
g.Medically significant acute or progressive neurological disease;
8.Surgery planned during the study period;
9.Bleeding diathesis;
10.Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the study vaccine;
11.History of any neurological symptoms or signs following administration of any vaccine, or anaphylactic shock following administration of any vaccine;
12.Known or suspected impairment/alteration of immune function, for example, resulting from:
a.Receipt of immunosuppressive therapy (any systemic corticosteroid therapy or cancer chemotherapy), Inhaled and topical steroids are allowed
b.Receipt of immunostimulants,
c.High risk for developing an immunocompromising disease;
13.Receipt of another vaccine within 3 weeks prior to Visit 1 or planned vaccination within 3 weeks following the last study vaccination;
14.Body Mass Index above 35 kg/m2;
15.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;
16.Any condition, which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives;
17.Site personnel and their relatives are excluded from participation
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Primary<br><br>To evaluate the magnitude of antibody responses to two doses of FLUAD-H5N1 influenza vaccine, each containing 7.5µg of H5N1 antigen administered 3 weeks apart.<br>;Secondary Objective: Secondary<br><br>To evaluate the cross-protection to two doses of a FLUAD-H5N1 influenza vaccine, containing 7.5µg of H5N1 antigen <br><br>Safety Objectives<br><br>To evaluate the safety and tolerability of two 0.5mL intramuscular (IM) injections of FLUAD-H5N1 influenza vaccine containing 7.5µg of influenza antigen, administered 3 weeks apart.<br>;Primary end point(s): ?HI antibody titers measured on Day 43 (i.e. 21 days after the 2nd vaccination) are considered to be the primary immunogenicity endpoint<br>?Analysis Population: Full Analysis Set (FAS)<br>?Sample size estimation can be based on results of FLUAD-H5N1 vaccine in V87P1, V87P2 and V87P4 already available (for details see section 6.9.2).<br>Each age cohort will contain 150 evaluable subjects receiving the FLUAD-H5N1 vaccine.
- Secondary Outcome Measures
Name Time Method