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Valuate the immune response and reactogenicity of H5N1 vaccination in a primed population (H5N3 adjuvanted or non-adjuvanted vaccine) compared to immunologically naïve subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | Primed subject with pandemic Vaccine |
|
| Group 2 | Active Comparator | Non Primed subject with pandemic Vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluad H5N1 Pandemic Influenza Vaccine | Biological | Two 0.5 mL doses of MF59-adjuvanted A/Vietnam/1194/2004 (H5N1 Clade 1) hemagglutinin (HA) subvirion influenza vaccine, containing 7.5 μg of H5N1 antigen,administered 3 weeks apart, IM in the deltoid muscle, preferably of the non-dominant arm. |
| Measure | Description | Time Frame |
|---|---|---|
| Cell-mediated immunity, magnitude, breath and kinetics of antibody response to 2 doses of MF59-adjuvanted H5N1 influenza vaccine, in subjects primed by previous vaccination with either MF59-adjuvanted or non-adjuvanted H5N3 influenza vaccine. | Days 1, 8, 15, 22, 43 and 202 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Objectives: safety and reactogenicity of the vaccine | Days 1, 8, 15, 22, 43 and 202 |
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Inclusion Criteria:
Subjects aged 18 to 65 years of age, mentally competent, who have signed an informed consent form after having received a detailed explanation of the study protocol;
In good health as determined by:
Subjects in the primed group previously received at least two doses of an H5N3 vaccine;
Able to understand and comply with all study procedures and to complete study diaries, can be contacted, and will be available for study visits.
Exclusion Criteria:
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;
Subjects who 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;
Subjects who experienced fever (defined as axillary temperature ≥38.0°C) within 3 days prior to Visit 1;
Subjects who are pregnant or breastfeeding;
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;
Subjects with any serious disease, such as:
Subjects for whom a surgery is planned during the study period;
Subjects with bleeding diathesis;
Subjects with hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the study vaccine;
Subjects with a history of any neurological symptoms or signs, or anaphylactic shock following administration of any vaccine;
Subjects with known or suspected impairment/alteration of immune function, for example, resulting from:
Receipt of another vaccine within 3 weeks prior to Visit 1 or planned vaccination within 3 weeks following the last study vaccination;
Subjects with a 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;
Subjects with any condition, which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Vaccines Information Service +41 61 324 1111 | Novartis | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Infectious Diseases Unit | Leicester | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19416838 | Result | Galli G, Hancock K, Hoschler K, DeVos J, Praus M, Bardelli M, Malzone C, Castellino F, Gentile C, McNally T, Del Giudice G, Banzhoff A, Brauer V, Montomoli E, Zambon M, Katz J, Nicholson K, Stephenson I. Fast rise of broadly cross-reactive antibodies after boosting long-lived human memory B cells primed by an MF59 adjuvanted prepandemic vaccine. Proc Natl Acad Sci U S A. 2009 May 12;106(19):7962-7. doi: 10.1073/pnas.0903181106. Epub 2009 Apr 27. |
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|
| ID | Term |
|---|---|
| D005585 | Influenza in Birds |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D001715 | Bird Diseases |
| D000820 | Animal Diseases |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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