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| Name | Class |
|---|---|
| Chengdu Olymvax Biopharmaceuticals Inc. | INDUSTRY |
| Third Military Medical University | OTHER |
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This is an open-label, dose-escalation pilot study with a total of 30 participants with 10 per dosage group. The aim of the pilot study is to explore the preliminary safety of an experimental recombinant staphylococcus aureus vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dosage vaccine | Experimental | High dosage of Staphylococcus aureus vaccine (60µg/0.6ml) |
|
| Middle dosage vaccine | Experimental | Middle dosage of Staphylococcus aureus vaccine (30µg/0.6ml) |
|
| Low dosage vaccine | Experimental | Low dosage of Staphylococcus aureus vaccine (15µg/0.6ml) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Staphylococcus aureus vaccine (60µg/per protein) | Biological | two doses of 60µg/0.6ml per dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of solicited adverse reactions after vaccination. | Occurrence of solicited site adverse reactions within 0-14 days after vaccination with the Recombinant Staphylococcus aureus vaccine (Escherichia coli). | within 0-14 days after the vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of unsolicited adverse reactions after vaccination. | Occurrence of unsolicited adverse reactions within 0-35 days after vaccination with the Recombinant Staphylococcus aureus vaccine (Escherichia coli). | within 0-35 days after the vaccination |
| Occurrence of serious adverse events after the vaccination. |
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Inclusion Criteria:
Exclusion Criteria:
First Immunization exclusion standard:
Following Immunization exclusion standard:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taixing county disease control and prevention | Taishing | Jiangsu | 225452 | China |
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| Staphylococcus aureus vaccine (30µg/per protein) | Biological | two doses of 30µg/0.6ml per dose |
|
| Staphylococcus aureus vaccine (15µg/per protein) | Biological | two doses of 15µg/0.6ml per dose |
|
Occurrence of serious adverse events within 6 months after the vaccination with the Recombinant Staphylococcus aureus vaccine (Escherichia coli). |
| within 6 months after the vaccination |
| Changes of the laboratory examinations after vaccination. | Changes of the laboratory examinations after vaccination with the Recombinant Staphylococcus aureus vaccine (Escherichia coli) on day 3. | day 3 after the vaccination |
| Changes of the laboratory examinations after vaccination. | Changes of the laboratory examinations after vaccination with the Recombinant Staphylococcus aureus vaccine (Escherichia coli) on day 7. | day 7 after the vaccination |
| Changes of the laboratory examinations after vaccination. | Changes of the laboratory examinations after vaccination with the Recombinant Staphylococcus aureus vaccine (Escherichia coli) on day 10. | day 10 after the vaccination |
| ID | Term |
|---|---|
| D013203 | Staphylococcal Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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