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This study will assess the immunogenicity, safety and tolerability of VN-0200 after intramuscular injections in Japanese healthy elderly subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: VN-0200 low dose | Experimental | Healthy elderly subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a. |
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| Group 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. |
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| Group 3: VN-0200 low dose | Experimental | Healthy elderly subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a adjuvanted with medium dose of MABH-9002b. |
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| Group 4: VN-0200 low dose | Experimental | Healthy elderly subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a adjuvanted with high dose of MABH-9002b. |
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| Group 5: VN-0200 medium dose | Experimental | Healthy elderly subjects will be randomized to receive intramuscular injection of medium dose of VAGA-9001a. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VN-0200 | Biological | VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) administered as an intramuscular injection; 2 shots in 4 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titer (GMT) of anti-RSV Subgroup A (RSV/A) Neutralizing Activity | Day 57 (28 days after the second dosing of the investigational product) | |
| Geometric Mean Fold Rise (GMFR) of Anti-RSV/A Neutralizing Activity | Day 57 (28 days after the second dosing of the investigational product) |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titer (GMT) of Anti-RSV/A Neutralizing Activity | Day 29 (the second dosing of the investigational product) | |
| Geometric Mean Fold Rise (GMFR) of Anti-RSV/A Neutralizing Activity | Day 29 (the second dosing of the investigational product) |
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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 |
|---|---|---|---|---|---|---|
| SOUSEIKAI PS Clinic | Hakata | Fukuoka | 812-0025 | Japan | ||
| SOUSEIKAI Sumida Hopital |
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
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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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| Group 6: VN-0200 medium dose | Experimental | Healthy elderly subjects will be randomized to receive intramuscular injection of medium dose of VAGA-9001a adjuvanted with high dose of MABH-9002b. |
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| Group 7: VN-0200 high dose | Active Comparator | Healthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a. |
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| Group 8: VN-0200 high dose | Experimental | Healthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a adjuvanted with low dose of MABH-9002b. |
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| Group 9: VN-0200 high dose | Experimental | Healthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a adjuvanted with medium dose of MABH-9002b. |
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| Group 10: 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. |
|
| Geometric Mean Titer (GMT) of Anti-RSV/B Neutralizing Activity | Day 29 (the second dosing of the investigational product) and Day 57 (28 days after the second dosing of the investigational product) |
| Geometric Mean Fold Rise (GMFR) of Anti-RSV/B Neutralizing Activity | Day 29 (the second dosing of the investigational product) and Day 57 (28 days after the second dosing of the investigational product) |
| Geometric Mean Titer (GMT) of Anti-VAGA-9001a Immunoglobulin G (IgG) | Day 29 (the second dosing of the investigational product) and Day 57 (28 days after the second dosing of the investigational product) |
| Geometric Mean Fold Rise (GMFR) of Anti-VAGA-9001a Immunoglobulin G (IgG) | Day 29 (the second dosing of the investigational product) and Day 57 (28 days after the second dosing of the investigational product) |
| VAGA-9001a Specific IFN-Gamma Production Responses | Day 29 (the second dosing of the investigational product) and Day 57 (28 days after the second dosing of the investigational product) |
| Number of Participants Reporting Solicited Adverse Events (Local and Systemic Adverse Reactions) and Side Reactions | Day 1 (the first dosing of the investigational product) up to Day 8, Day 29 (the second dosing of the investigational product) up to Day 36 and at time of discontinuation (whichever comes first), up to approximately 1 month |
| Number of Participants Reporting Non-Solicited Adverse Events and Side Reactions | Day 1 (the first dosing of the investigational product) up to Day 57 (28 days after second dosing of the investigational product) and at time of discontinuation (whichever comes first), up to approximately 2 months |
| Number of Participants Reporting Serious Adverse Events and Side Reactions | From date of informed consent up to approximately 12 months |
| Number of Participants Reporting Potential Immune-Mediated Disease | Day 1 (the first dosing of the investigational product) up to the time of follow-up and discontinuation (up to approximately 12 months) |
| Sumida City |
| Tokyo |
| 130-0004 |
| Japan |
| SOUSEIKAI Nishi-Kumamoto Hospital | Kumamoto | 861-4157 | Japan |
| D014777 | Virus Diseases |
| D007239 | Infections |