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To determine optimum dose level for a single visit multidose intradermal injection of rabies vaccine with the aim to induce immunological memory in all subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A - ID | Experimental | Intradermal administration. 20% dose in a single visit. |
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| B - ID | Experimental | Intradermal administration. 40% dose in a single visit. |
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| C - ID | Experimental | Intradermal administration. 60% dose in a single visit. |
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| D - IM | Active Comparator | 1x IM |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rabies vaccine | Biological | Compare ID administration to IM administration. 1 visit schedule. |
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| Measure | Description | Time Frame |
|---|---|---|
| Memory response in vaccinated subjects 1 year after primary vaccination (defined as seroprotection rate for all subjects within 7 days post-booster in a simulated post-exposure scenario) | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emile Jonker, MD | Contact | e.f.f.jonker@lumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Leo Visser, M, PhD | LUMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leiden University Medical Center | Recruiting | Leiden | South Holland | 2333ZA | Netherlands |
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| ID | Term |
|---|---|
| D011819 | Rabies Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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