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Sponsor: Sanofi Pasteur, a Sanofi Company
Conditions: Diphtheria, Tetanus, Poliomyelitis
Interventions: Diphtheria, tetanus, polio and pertussis vaccination
Countries: France
PRIMARY OBJECTIVES * To describe in 11 to 13-year-old children previously vaccinated with either REVAXIS or DT Polio at 6 years of age the antibody persistence against diphtheria, tetanus, and poliovirus types 1, 2 and 3 * To describe one month after a booster dose of TETRAVAC-ACELLULAIRE the immune responses against diphtheria, tetanus, and poliovirus types 1, 2 and 3 SECONDARY OBJECTIVES * To describe other parameters of the antibody persistence against diphtheria, tetanus and poliomyelitis antigens * To describe other parameters of the immune responses to diphtheria, tetanus and poliomyelitis antigens one month after a booster dose of TETRAVAC-ACELLULAIRE * To describe the safety profile of a booster dose of TETRAVAC-ACELLULAIRE
Sex: ALL
Age: 11 Years to 13 Years
Healthy volunteers: Yes
Study type: INTERVENTIONAL
Inclusion Criteria: * Healthy child 11 to 13 years of age previously vaccinated in Study F05-TdI-301 Exclusion Criteria: * Immunization against diphtheria, tetanus, pertussis and/or poliomyelitis beyond Study F05-TdI-301 * Previous clinical or bacteriological diagnosis of diphtheria, tetanus, pertussis or poliomyelitis * Known or suspected immune dysfunction * Receipt of medications / vaccination that may interfere with study assessments * Known true hypersensitivity to any of the vaccine components or to a vaccine containing the same substances * Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition * Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection * Any medical condition that might interfere with the evaluation of the study objectives * Febrile illness
- Angers, France
- Arras, France
- Asnières, France
- Bersée, France
- Besançon, France
- Besançon, France
- Blois, France
- Blois, France
- Boulogne-Billancourt, France
- Brest, France
- Caen, France
- Caen, France
- Champdeniers, France
- Châlons-en-Champagne, France
- Chigny-les-Roses, France
- Cholet, France
- Clamart, France
- Collombey Les Belles, France
- Collombey Les Belles, France
- Dax, France
- Draguignan, France
- Essey-lès-Nancy, France
- Essey-lès-Nancy, France
- Essey-lès-Nancy, France
- Floirac, France
- Frouard, France
- Haguenau, France
- Illkirch-Graffenstaden, France
- Le Havre, France
- Le Havre, France
- + 15 more on CT.gov