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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-511194-29-00 | EU Trial (CTIS) Number |
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The purpose of this first time in humans trial is to evaluate the safety, reactogenicity and immunogenicity of AVX70120 and of AVX70481 in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AVX70120 low dose level | Experimental | Participants in this arm receive AVX70120 low dose level at Day 1 |
|
| AVX70120 middle dose level | Experimental | Participants in this arm receive AVX70120 middle dose level at Day 1 |
|
| AVX70120 high dose level | Experimental | Participants in this arm receive AVX70120 high dose level at Day 1 |
|
| AVX70481 low dose level | Experimental | Participants in this arm receive AVX70481 low dose level at Day 1 |
|
| AVX70481 middle dose level | Experimental | Participants in this arm receive AVX70481 middle dose level at Day 1 |
|
| AVX70481 high dose level | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVX70120 low dose level | Biological | Low dose level of AVX70120, AstriVax' investigational vaccine for the prevention of yellow fever |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of solicited adverse events | During a 14-day follow-up period after vaccination | |
| Occurrence of unsolicited adverse events | From Day 1 up to 1 month after vaccination | |
| Occurrence of hematological and biochemical laboratory abnormalities | From Day 1 up to 6 months after vaccination | |
| Occurrence of adverse events of special interest | From Day 1 up to 1 year after vaccination | |
| Occurrence of serious adverse events | From Day 1 up to 1 year after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Humoral immune response following administration of the investigational vaccines | From Day 1 up to 1 year after vaccination |
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Inclusion Criteria:
Exclusion Criteria:
Note: other protocol-defined inclusion / exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for the Evaluation of Vaccination (CEV) | Antwerp | Belgium | ||||
| University Hospital Ghent - Centrum voor Vaccinologie (CEVAC) |
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Participants in this arm receive AVX70481 high dose level at Day 1 |
|
| Placebo | Placebo Comparator | Participants in this arm receive Placebo at Day 1 |
|
| AVX70120 middle dose level | Biological | Middle dose level of AVX70120, AstriVax' investigational vaccine for the prevention of yellow fever |
|
| AVX70120 high dose level | Biological | High dose level of AVX70120, AstriVax' investigational vaccine for the prevention of yellow fever |
|
| AVX70481 low dose level | Biological | Low dose level of AVX70481, AstriVax' investigational vaccine for the prevention of rabies |
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| AVX70481 middle dose level | Biological | Middle dose level of AVX70481, AstriVax' investigational vaccine for the prevention of rabies |
|
| AVX70481 high dose level | Biological | High dose level of AVX70481, AstriVax' investigational vaccine for the prevention of rabies |
|
| Placebo | Other | Placebo |
|
| Ghent |
| Belgium |
| ID | Term |
|---|---|
| D015004 | Yellow Fever |
| D011818 | Rabies |
| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D001102 | Arbovirus Infections |
| D014777 | Virus Diseases |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006482 | Hemorrhagic Fevers, Viral |
| D018353 | Rhabdoviridae Infections |
| D018701 | Mononegavirales Infections |
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| ID | Term |
|---|---|
| D005430 | Floors and Floorcoverings |
| ID | Term |
|---|---|
| D005160 | Facility Design and Construction |
| D001108 | Architecture |
| D013676 | Technology, Industry, and Agriculture |
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