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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2031210069 | Other Identifier | Japan Registry of Clinical Trials |
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This study will assess the safety, tolerability, and immunogenicity of VN-0200 after intramuscular injections in Japanese healthy adults and elderly subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Step 1: VN-0200 low dose | Experimental | Healthy adults subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a adjuvanted with low dose of MABH-9002b. |
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| Step 1: VN-0200 medium dose | Experimental | Healthy adults subjects will be randomized to receive intramuscular injection of medium dose of VAGA-9001a adjuvanted with medium dose of MABH-9002b. |
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| Step 1: VN-0200 high dose | Experimental | Healthy adults subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a adjuvanted with high dose of MABH-9002b. |
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| Step 1: Placebo | Placebo Comparator | Healthy adults and elderly subjects will be randomized to receive intramuscular injection of placebo. |
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| Step 2: VN-0200 low dose | Experimental | Healthy elderly subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a adjuvanted with low dose of MABH-9002b. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VN-0200 | Biological | VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Treatment-emergent Adverse Events | From first administration through 28 days post second administration | |
| Number of Participants Reporting Local and Systemic Adverse Events | From first administration up to 14 days after second administration | |
| Number of Participants Reporting Serious Adverse Events | From date of informed consent up to approximately 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Fold Rise (GMFR) of Anti-RSV Specific Neutralizing Activity | Day 29 and Day 57 post-dose and at the time of discontinuation (whichever occurs first), up to approximately 2 months | |
| Geometric Mean Titer (GMT) of Anti-VAGA-9001a IgG | Day 1 (pre-dose), Day 29 and Day 57 post-dose, and at the time of discontinuation (whichever occurs first), up to approximately 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Study Leader | Daiichi Sankyo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Corporation Association Shinanokai Shinanozaka Clinic | Shinjuku-Ku | Tokyo | 160-0017 | Japan |
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| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
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| Step 2: VN-0200 dose medium dose | Experimental | Healthy elderly subjects will be randomized to receive intramuscular injection of medium dose of VAGA-9001a adjuvanted with medium dose of MABH-9002b. |
|
| Step 2: VN-0200 high dose | Experimental | Healthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a adjuvanted with high dose of MABH-9002b. |
|
| Step 2: Placebo | Placebo Comparator | Healthy adults and elderly subjects will be randomized to receive intramuscular injection of placebo. |
|
| Placebo | Biological | Placebo administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total |
|
| Geometric Mean Titer (GMT) of Anti-RSV IgG | Day 1 (pre-dose), Day 29 and Day 57 post-dose, and at the time of discontinuation (whichever occurs first), up to approximately 2 months |
| Number of IFN-γ spot-forming cells in PBMC Detected by ELISPOT | Day 1 (pre-dose), Day 29 and Day 57 post-dose, and at the time of discontinuation (whichever occurs first), up to approximately 2 months |
| D014777 | Virus Diseases |
| D007239 | Infections |