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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005557-31 | EudraCT Number | ||
| B9371010 | Other Identifier | Pfizer |
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The purpose of this study is to evaluate TBE antibody persistence from 7 to 10 years after the first booster TBE vaccination with FSME-IMMUN 0.5ml.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Seropersistence evaluation + 2nd booster vaccination | Experimental | Blood will be drawn to assess the seropersistence of TBE virus antibodies at 82, 94, 106 and 118 months after the first booster vaccination with FSME-IMMUN 0.5ml administered during the first precursor study. Timing of the second booster vaccination will depend on the level of serum TBE antibodies observed during the study. Blood will be drawn 21 - 35 days after vaccination to assess the booster response. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FSME-IMMUN 0.5 ml | Biological | Solution/suspension for injection (intramuscular injection into the deltoid muscle of the right or left upper arm). Dosage frequency of booster vaccination: dependent on serum TBE antibodies. |
| Measure | Description | Time Frame |
|---|---|---|
| Seropositivity rate measured by neutralization test (NT) 82, 94, 106 and 118 months after the first booster TBE vaccination administered in the first precursor study and after the booster vaccination in this study | 118 months |
| Measure | Description | Time Frame |
|---|---|---|
| Seropositivity rate measured by ELISA test 82, 94, 106 and 118 months after the first booster TBE vaccination administered in the first precursor study and after the booster vaccination in this study | 118 months | |
| Antibody titers 82, 94, 106 and 118 months after the first booster TBE vaccination administered in the first precursor study and after the booster vaccination in this study measured by ELISA and by NT |
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Inclusion Criteria:
Subjects who participated in the first and second precursor studies will be eligible for participation in this study if:
Exclusion Criteria:
Subjects will be excluded from participation in this study if they:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prywatny Gabinet Lekarski | Dębica | 39-200 | Poland | |||
| "John Paul II" Cracow Specialist Hospital, Department of Pediatric Neuroinfections and Neurology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28545923 | Derived | Konior R, Brzostek J, Poellabauer EM, Jiang Q, Harper L, Erber W. Seropersistence of TBE virus antibodies 10 years after first booster vaccination and response to a second booster vaccination with FSME-IMMUN 0.5mL in adults. Vaccine. 2017 Jun 16;35(28):3607-3613. doi: 10.1016/j.vaccine.2017.03.059. Epub 2017 May 22. |
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| ID | Term |
|---|---|
| D004675 | Encephalitis, Tick-Borne |
| ID | Term |
|---|---|
| D004671 | Encephalitis, Arbovirus |
| D018792 | Encephalitis, Viral |
| D020805 | Central Nervous System Viral Diseases |
| D002494 | Central Nervous System Infections |
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| 118 months |
| Fold increase in antibody concentration after the booster vaccination administered as compared to before the booster vaccination in this study measured by ELISA and by NT | 118 months |
| Krakow |
| 31-202 |
| Poland |
| D007239 | Infections |
| D000069544 | Infectious Encephalitis |
| D001102 | Arbovirus Infections |
| D000079426 | Vector Borne Diseases |
| D017282 | Tick-Borne Diseases |
| D014777 | Virus Diseases |
| D012327 | RNA Virus Infections |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D004660 | Encephalitis |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000090862 | Neuroinflammatory Diseases |