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Primary objective:
Secondary objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REPEVAX® after REVAXIS® | Experimental | REVAXIS® at Visit 1 (Day 0) and REPEVAX®) at Visit 2 (Day 28). |
|
| REPEVAX® after Placebo | Active Comparator | Placebo at Visit 1 (Day 0) and REPEVAX®) at Visit 2 (Day 28). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REPEVAX® after REVAXIS® | Biological | Tetanus, diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine after tetanus, diphtheria, poliomyelitis (inactivated) |
| Measure | Description | Time Frame |
|---|---|---|
| injection sites reactions and systemic events during the 7 day-safety period post-vaccination with TdaP-IPV vaccine. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| injection-site adverse reactions and systemic adverse events during the 14 day-safety period post-vaccination with Td-IPV vaccine, TdaP-IPV vaccine and placebo and serious adverse events | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clermont-Ferrand | France | |||||
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| REPEVAX® after Placebo | Biological | Tetanus, diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine after placebo |
|
| Lyon |
| France |
| Montpellier | France |
| Paris | France |