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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003314-16 | EudraCT Number |
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The purpose of this study is to determine the immunogenicity and tolerability of one 0.5 mL intramuscular (IM) injection of FLUVAL AB-like trivalent influenza vaccine containing 6μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens in adults and elderly people.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FAB-6011 | Experimental | One 0.5 mL injection of FAB-6011 trivalent influenza vaccine containing 6μg HA of seasonal A/H1N1, A/H3N2 and B influenza antigens |
|
| FLUVALAB | Active Comparator | One 0.5 mL injection of FLUVAL AB trivalent influenza vaccine containing 15μg HA of seasonal A/H1N1, A/H3N2 and B influenza antigens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaccination with FAB-6011 | Biological | One 0.5 mL injection of FAB-6011 trivalent influenza vaccine containing 6μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measures of immunogenicity | The measures of immunogenicity (by using HI test) are:
| 21-28 days following vaccination |
| Measures of safety | The measures of safety are: Number and percentage of subjects with at least
| 21-28 days following vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Measures of long term immunogenicity | The measures of long term immunogenicity (by using HI test) are:
| 110-120 days following vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gabor Kollar, MD | Omninvest Ltd | Study Director |
| Ferenc Tamás, MD | Family Doctor's Office, Pilisvörösvár | Principal Investigator |
| Ágnes Hasitz, MD | Family Doctor's Office, Szentendre | Principal Investigator |
| Judit Simon, MD | Family Doctor's Office, Budapest | Principal Investigator |
| Barna Bőze, MD | Family Doctor's Office, Hatvan | Principal Investigator |
| Tibor Hrutka, MD | Family Doctor's Office, Vecsés | Principal Investigator |
| Péter Torzsa, MD | Family Doctor's Office, Budapest | Principal Investigator |
| Péter Vajer, MD | Family Doctor's Office, Biatorbágy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Péter Vajer | Biatorbágy | Pest County | 2051 | Hungary | ||
| Barna Bőze |
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|
| Vaccination with FluvalAB | Biological | One 0.5 mL injection of FLUVAL AB trivalent influenza vaccine containing 15μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens. |
|
|
| Measures of long term safety | The measures of long term safety are: Number and percentage of subjects with at least
| 110-120 days following vaccination |
| Hatvan |
| Pest County |
| 3000 |
| Hungary |
| Family Doctor's Office | Szentendre | Pest County | 2000 | Hungary |
| Tibor Hrutka | Vecsés | Pest County | 2220 | Hungary |
| Family Doctor's Office | Budapest | 1083 | Hungary |
| Family Doctor's Office | Budapest | 1136 | Hungary |
| Family Doctor's Office | Pilisvörösvár | 2085 | Hungary |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D007239 | Infections |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D014611 | Vaccination |
| ID | Term |
|---|---|
| D016233 | Immunotherapy, Active |
| D007114 | Immunization |
| D007167 | Immunotherapy |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |
| D011322 | Primary Prevention |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D003140 | Communicable Disease Control |
| D015980 | Public Health Practice |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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