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Phase 1 clinical trial to evaluate the safety of RSV-1 and RSV-2 vaccines in healthy adults aged 19 to 80 years who have voluntarily given written consent to participate in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RSV-1 | Experimental |
| |
| RSV-2 | Experimental |
| |
| Normal Saline | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EuRSV | Biological | Healthy adults received 0.5mL single intramuscular dose on Day 0 and Day 28. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of solicited adverse events | local and systemic AEs | within 7 days post vaccination |
| Occurrence of immediate adverse events | local and systemic AEs | within 30 minutes post vaccination |
| Occurrence of unsolicited adverse events | local and systemic AEs | within 52 weeks post vaccination |
| Occurrence of serious adverse events | local and systemic AEs | within 52 weeks post vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univsersity Hospital | Seoul | South Korea |
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| Placebo Comparator | Other | Healthy adults received 0.5mL single intramuscular dose on Day 0 and Day 28. |
|
| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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