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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-000895-25 |
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The present study will evaluate the immunogenicity, safety and tolerability of two doses of monovalent inactivated influenza vaccine that is adjuvanted with MF59C.1 (MF59) and uses a surface antigen from a potential pandemic virus strain candidate (H5N1) in Adult and Elderly Subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monovalent inactivated influenza vaccine | Biological | 2 doses of monovalent inactivated influenza vaccine with adjuvant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of antibody response to a monovalent inactivated flu vaccine adjuvanted with MF59 and uses a surface antigen from a potential pandemic homologous virus strain candidate (H5N1), as measured by HI test,MN test,SRH test,on day 0,21,42 and 201 | 6 months | |
| Evaluation of safety of the monovalent inactivated influenza vaccine that is adjuvanted with MF59C.1 (MF59) and uses a surface antigen from a potential pandemic virus strain candidate (H5N1) in Adult and Elderly Subjects. | 6 months |
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Inclusion Criteria:
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;
In good health as determined by:
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.
Exclusion Criteria:
Previous receipt of any H5 vaccine;
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;
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;
Experienced fever (defined as axillary temperature 38.0°C) within 3 days prior to Visit 1;
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;
Any serious disease, such as:
Surgery planned during the study period;
Bleeding diathesis;
Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the study vaccine;
History of any neurological symptoms or signs following administration of any vaccine, or anaphylactic shock following administration of any vaccine;
Known or suspected impairment/alteration of immune function, for example, resulting from:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Vaccines | Novartis Vaccines | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pestlőrinc-Pestszentimre Egészségügyi Szolgáltató KFT | Budapest | 1183 | Hungary | |||
| Bács-Kiskun Megyei Kórház Tüdőgondozó Intézet |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23081815 | Result | Bihari I, Panczel G, Kovacs J, Beygo J, Fragapane E. Assessment of antigen-specific and cross-reactive antibody responses to an MF59-adjuvanted A/H5N1 prepandemic influenza vaccine in adult and elderly subjects. Clin Vaccine Immunol. 2012 Dec;19(12):1943-8. doi: 10.1128/CVI.00373-12. Epub 2012 Oct 17. |
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| Kecskemét |
| 6000 |
| Hungary |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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