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A single blind, randomized, comparative, multicentre clinical trial of the immunogenicity and safety of booster immunization with bivalent vaccine against tetanus and diphtheria CLODIVAC (IBSS BIOMED S.A.) and Td-Impfstoff Mérieux (Sanofi Pasteur) in healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clodivac | Experimental |
| |
| Td-Impfstoff Merieux | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clodivac | Biological | A dose of 0.5 ml should be administered intramuscularly into deltoid muscle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion | The primary endpoint is the seroconversion in 28 days follow-up. The proportion of subjects complying the positive criteria of seroconversion will be calculated. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| The ratio of geometric mean concentrations (GMC) of post-vaccination tetanus antibodies and diphtheria antibodies between test and reverence. |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SPZOZ w Bochni Szpital Powiatowy im. bł. M. Wieckiej | Bochnia | Poland | ||||
| Krakowski Szpital Specjalistyczny im. Jana Pawła II |
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| ID | Term |
|---|---|
| D004165 | Diphtheria |
| D013742 | Tetanus |
| ID | Term |
|---|---|
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| Td-Impfstoff Merieux | Biological | One dose (0.5 ml) intramuscular, preferably in the deltoid muscle of the upper arm. |
|
| 28 days |
| Krakow |
| Poland |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003015 | Clostridium Infections |