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PRIMARY OBJECTIVES
SECONDARY OBJECTIVES
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TETRAVAC-ACELLULAIRE | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diphtheria, tetanus, polio and pertussis vaccination | Biological | 1 dose of TETRAVAC-ACELLULAIRE (0.5 mL) at Day 0 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with an anti-diphtheria concentration ≥0.01 IU/mL | Pre-booster dose (Day 0) | |
| Proportion of subjects with an anti-tetanus concentration ≥0.01 IU/mL | Pre-booster dose (Day 0) | |
| Proportion of subjects with an anti-polio type 1 titer ≥ 8 (1/dilution) | Pre-booster dose (Day 0) | |
| Proportion of subjects with an anti-polio type 2 titer ≥ 8 (1/dilution) | Pre-booster dose (Day 0) | |
| Proportion of subjects with an anti-polio type 3 titer ≥ 8 (1/dilution) | Pre-booster dose (Day 0) | |
| Proportion of subjects with an anti-diphtheria concentration ≥0.1 IU/mL | 1 month post-booster dose | |
| Proportion of subjects with an anti-tetanus concentration ≥0.1 IU/mL | 1 month post-booster dose | |
| Proportion of subjects with an anti-polio type 1 titer ≥8 (1/dilution) | 1 month post-booster dose | |
| Proportion of subjects with an anti-polio type 2 titer ≥8 (1/dilution) | 1 month post-booster dose | |
| Proportion of subjects with an anti-polio type 3 titer ≥8 (1/dilution) |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean titer for diphtheria | Pre-booster (Day 0) and 1 month post-booster dose | |
| Geometric mean titer for tetanus | Pre-booster (Day 0) and 1 month post-booster dose | |
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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 |
|---|---|---|---|---|---|---|
| SPMSD Investigational Site 120 | Angers | France | ||||
| SPMSD Investigational Site 103 |
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| 1 month post-booster dose |
| Geometric mean titer for polio type 1 |
| Pre-booster (Day 0) and 1 month post-booster dose |
| Geometric mean titer for polio type 2 | Pre-booster (Day 0) and 1 month post-booster dose |
| Geometric mean titer for polio type 3 | Pre-booster (Day 0) and 1 month post-booster dose |
| Solicited injection site and solicited systemic reactions | From Day 0 to Day 7 post vaccination |
| Unsolicited injection site reactions and unsolicited systemic adverse events | From Day 0 to Day 28 days post vaccination |
| Serious adverse events | From signature of informed consent up to last study visit of the subject |
| Arras |
| France |
| SPMSD Investigational Site 155 | Asnières | France |
| SPMSD Investigational Site 125 | Bersée | France |
| SPMSD Investigational Site 121 | Besançon | France |
| SPMSD Investigational Site 141 | Besançon | France |
| SPMSD Investigational Site 124 | Blois | France |
| SPMSD Investigational Site 161 | Blois | France |
| SPMSD Investigational Site 194 | Boulogne-Billancourt | France |
| SPMSD Investigational Site 148 | Brest | France |
| SPMSD Investigational Site 117 | Caen | France |
| SPMSD Investigational Site 147 | Caen | France |
| SPMSD Investigational Site 163 | Champdeniers | France |
| SPMSD Investigational Site 135 | Châlons-en-Champagne | France |
| SPMSD Investigational Site 145 | Chigny-les-Roses | France |
| SPMSD Investigational Site 157 | Cholet | France |
| SPMSD Investigational Site 101 | Clamart | France |
| SPMSD Investigational Site 160 | Collombey Les Belles | France |
| SPMSD Investigational Site 162 | Collombey Les Belles | France |
| SPMSD Investigational Site 139 | Dax | France |
| SPMSD Investigational Site 193 | Draguignan | France |
| SPMSD Investigational Site 106 | Essey-lès-Nancy | France |
| SPMSD Investigational Site 123 | Essey-lès-Nancy | France |
| SPMSD Investigational Site 164 | Essey-lès-Nancy | France |
| SPMSD Investigational Site 136 | Floirac | France |
| SPMSD Investigational Site 114 | Frouard | France |
| SPMSD Investigational Site 150 | Haguenau | France |
| SPMSD Investigational Site 113 | Illkirch-Graffenstaden | France |
| SPMSD Investigational Site 197 | Le Havre | France |
| SPMSD Investigational Site 198 | Le Havre | France |
| SPMSD Investigational Site 107 | Lingolsheim | France |
| SPMSD Investigational Site 115 | Louverné | France |
| SPMSD Investigational Site 140 | Manduel | France |
| SPMSD Investigational Site 116 | Maromme | France |
| SPMSD Investigational Site 153 | Marseille | France |
| SPMSD Investigational Site 134 | Montpellier | France |
| SPMSD Investigational Site 129 | Nogent-sur-Marne | France |
| SPMSD Investigational Site 133 | Ostwald | France |
| SPMSD Investigational Site 128 | Poitiers | France |
| SPMSD Investigational Site 130 | Pont-à-Mousson | France |
| SPMSD Investigational Site 151 | Quimper | France |
| SPMSD Investigational Site 102 | Rouen | France |
| SPMSD Investigational Site 110 | Rouen | France |
| SPMSD Investigational Site 199 | Rouen | France |
| SPMSD Investigational Site 152 | Saint-Ouen | France |
| ID | Term |
|---|---|
| D004165 | Diphtheria |
| D013742 | Tetanus |
| D011051 | Poliomyelitis |
| ID | Term |
|---|---|
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003015 | Clostridium Infections |
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D013745 | Tetanus Toxoid |
| ID | Term |
|---|---|
| D014121 | Toxoids |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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