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Primary objective:
To demonstrate the non inferiority between REVAXIS® and DT Polio® when given as a second booster to healthy 6 year-old children .
Secondary objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REVAXIS® | Biological |
| ||
| DT-Polio® |
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 |
|---|---|---|---|---|---|---|
| Albertville | 95880 | France | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21441781 | Derived | Gajdos V, Soubeyrand B, Vidor E, Richard P, Boyer J, Sadorge C, Fiquet A. Immunogenicity and safety of combined adsorbed low-dose diphtheria, tetanus and inactivated poliovirus vaccine (REVAXIS ((R))) versus combined diphtheria, tetanus and inactivated poliovirus vaccine (DT Polio ((R))) given as a booster dose at 6 years of age. Hum Vaccin. 2011 May;7(5):549-56. doi: 10.4161/hv.7.5.14982. Epub 2011 May 1. |
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|
| Albi |
| 81000 |
| France |
| Angers | 49100 | France |
| Annecy | 74000 | France |
| Anzin | 59410 | France |
| Arras | 62000 | France |
| Asnières | 92600 | France |
| Avion | 62210 | France |
| Bassens | 33530 | France |
| Bersée | 59235 | France |
| Besançon | 25000 | France |
| Blois | 41000 | France |
| Boulogne | 92100 | France |
| Brest | 29200 | France |
| Broglie | 27270 | France |
| Caen | 14000 | France |
| Chalon-en-champagne | 51000 | France |
| Champdeniers | 79220 | France |
| Chigny-les-Roses | 51500 | France |
| Cholet | 49300 | France |
| Claix | 38640 | France |
| Clamart | 92141 | France |
| Collombey Les Belles | 54170 | France |
| Draguignan | 83300 | France |
| Enghien-les-Bains | 95880 | France |
| Floirac | 33270 | France |
| Frouard | 54390 | France |
| Haguenau | 67500 | France |
| Illkirch-Graffenstaden | 67400 | France |
| Issy-les-Moulineaux | 92130 | France |
| La Neuville-Roy | 60190 | France |
| Laon | 02000 | France |
| Le Havre | 76600 | France |
| Les Pieux | 50340 | France |
| Louverné | 53950 | France |
| Louvigné-de-Bais | 35680 | France |
| Manduel | 30129 | France |
| Marcq-en-barouel | 59700 | France |
| Maromme | 76150 | France |
| Marseille | 13004 | France |
| Miniac-Morvan | 35540 | France |
| Montpellier | 34080 | France |
| Montsang/orge | 91390 | France |
| Morangis | 91420 | France |
| Nancy | 54000 | France |
| Nantes | 44300 | France |
| Nogent-sur-Marne | 94130 | France |
| Ostwald | 67540 | France |
| Paris | 75013 | France |
| Paris | 75019 | France |
| Plouzané | 29280 | France |
| Poitiers | 86000 | France |
| Pont-à-Mousson | 54700 | France |
| Quimper | 29000 | France |
| Rouen | 76000 | France |
| Rouen | 76100 | France |
| Saint Sebastien Sur Loir | 44230 | France |
| Saint-Ouen | 93400 | France |
| Saint-Raphaël | 83700 | France |
| Sanary Mer | 83110 | France |
| Sèvres | 92310 | France |
| Strasbourg | 67000 | France |
| Toulouse | 31000 | France |
| Villemomble | 93250 | 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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