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| Name | Class |
|---|---|
| Butantan Foundation | OTHER |
| Coalition for Epidemic Preparedness Innovations | OTHER |
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This is an observational study with primary data collection, which will combine a prospective safety cohort study and an SCRI study.
This prospective safety cohort study will be conducted in selected Brazilian municipalities participating in a pilot vaccination strategy. A total of 5,000 participants will be recruited. The primary objective is to estimate the incidence rates of a predefined set of AEs which constitute safety concerns. The secondary objectives are to measure the relative risk associated with VLA1553 administration for a predefined set of AEs which constitute safety concerns, and to assess the frequency of occurrence of any collected AE which are medically attended or meet the criteria of seriousness This study also aims to investigate VLA1553's safety in underrepresented populations by collecting all AEs, not just AEs which constitute safety concerns.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Live-attenuated CHIKV vaccine VLA1553 | Biological | Non-interventional study: VLA1553 is used in the pilot vaccination strategy which will start along with this observational study. |
| Measure | Description | Time Frame |
|---|---|---|
| To estimate the incidence rates of a predefined set of AEs which constitute safety concerns according to the VLA1553 Risk Management Plan following the administration of the live-attenuated VLA1553 vaccine | For each safety concern, the risk windows after VLA1553 administration are defined as:
| From enrollment until Day 60 |
| Measure | Description | Time Frame |
|---|---|---|
| To measure the relative risk associated with VLA1553 administration for a predefined set of AEs which constitute safety concerns as per the VLA1553 Risk Management Plan for those AEs that have a defined risk window following vaccination. | From enrollment until Day 120 | |
| To assess the frequency of occurrence of predefined AEs which are medically attended or meet the criteria of seriousness. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the frequency of occurrence of AEs (not exclusively those of safety concern) following VLA1553 vaccination when co-administered or concomitantly administered with other vaccines. | From enrollment until Month 6 | |
| To assess the frequency of occurrence of AEs (not exclusively those of safety concern) in populations underrepresented or excluded in clinical trials with VLA1553. |
Inclusion Criteria:
Exclusion Criteria:
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This study will collect data from approximately 5,000 individuals who received VLA1553, as per label, as part of the pilot vaccination strategy in selected municipalities in Brazil.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Federal Do Ceará | Fortaleza | Ceará | 60430-160 | Brazil | ||
| Universidade Federal de Minas Gerais, CT Terapias Avançadas e Inovadoras |
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| From enrollment until Month 6 |
|
| From enrollment until Month 6 |
| Belo Horizonte |
| Minas Gerais |
| 31270-901 |
| Brazil |
| Centro de Pesquisas Clínicas Universidade Federal Sergipe, Hospital e Maternidade São João de Deus | Laranjeiras | Sergipe | 49060-025 | Brazil |
| Fundação Faculdade Regional De Medicina De São José Do Rio Preto | São Pedro | São Paulo | 15090-000 | Brazil |
| ID | Term |
|---|---|
| D065632 | Chikungunya Fever |
| ID | Term |
|---|---|
| D018354 | Alphavirus Infections |
| D001102 | Arbovirus Infections |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D014777 | Virus Diseases |
| D014036 | Togaviridae Infections |
| D012327 | RNA Virus Infections |
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