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vaccination",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"BIOLOGICAL","Diphtheria, tetanus, polio and pertussis vaccination","1 dose of REPEVAX (0.5 mL) at Day 0, 1 dose of REVAXIS (0.5 mL) 1 month later and 1 dose of REVAXIS 6 month later",[9],[21],{"name":22,"affiliation":23,"role":24},"Medical Director","Sanofi Pasteur, a Sanofi Company","STUDY_DIRECTOR",[26,37,44,51,58,65,72,81,88,95,102,109],{"facility":27,"status":11,"city":28,"state":11,"zip":11,"country":29,"countryCode":30,"cosmosGeoPoint":31,"geoPoint":36,"contacts":11},"Sanofi Pasteur MSD investigational 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and Immunogenicity Study of a Diphtheria, Tetanus, Acellular Pertussis and Poliomyelitis Vaccine (REPEVAX) Followed by 2 Doses of a Diphtheria, Tetanus and Poliomyelitis Vaccine (REVAXIS) in Subjects of 40 Years of Age or Older","An Open-label, Multicentre Study to Evaluate the Immunogenicity and Safety of One Dose of a Diphtheria, Tetanus, Acellular Pertussis and Poliomyelitis Vaccine (REPEVAX) Followed by 2 Doses of a Diphtheria, Tetanus and Poliomyelitis Vaccine (REVAXIS) in Subjects of 40 Years of Age or Older Without a Previous Diphtheria- and Tetanus-containing Booster Within the Last 20 Years","Inclusion Criteria:\n\n* Adults aged ≥40 years\n* No receipt of a booster dose with a tetanus-, diphtheria-containing vaccine within the last 20 years\n\nExclusion Criteria:\n\n* Medically diagnosed pertussis disease within the last 10 years\n* Receipt of medication \u002F vaccine that may interfere with study assessments\n* Febrile illness or moderate or severe acute illness\u002Finfection\n* Know pregnancy\n* History of hypersensitivity or anaphylactic or other allergic reactions to any of the vaccine components, or history of a life-threatening reaction to the study vaccines or a vaccine containing any of the same substances\n* History of Guillain Barré syndrome or brachial neuritis following a previous vaccination\n* History of encephalopathy of unknown origin within 7 days after immunization with a pertussis-containing vaccine or neurological disorders\n* Known or suspected immune dysfunction\n* Thrombocytopenia, bleeding disorder or anticoagulants contraindicating intramuscular vaccination\n* Chronic disease or intercurrent illness that might interfere with study assessments",true,"ALL","40 Years",{"count":129,"type":130},342,"ACTUAL","INTERVENTIONAL",[133],"PHASE3","Primary objective:\n\n* To demonstrate that 3 doses of a vaccine containing Td-IPV valences administered in a 0, 1 and 6-month schedule induce an acceptable immune response in terms of seroprotection rates (SPR) against diphtheria, tetanus and poliomyelitis 1, 2 and 3, in subjects of 40 years of age or older with no diphtheria- and tetanus-containing booster within the last 20 years\n* To evaluate the percentage of subjects with antibody titre ≥5 EU\u002FmL (ELISA) for each of the pertussis components (PT, FHA, PRN and FIM) after 1 dose of REPEVAX in these subjects\n\nSecondary objectives:\n\n* If the primary objective is achieved, to determine whether 1 or 2 doses of a vaccine containing Td-IPV valences induce an acceptable response in terms of seroprotection rates (SPR) against diphtheria, tetanus and poliomyelitis 1, 2 and 3, in subjects of 40 years of age or older with no diphtheria- and tetanus-containing booster within the last 20 years\n* To describe the immune responses to REPEVAX in these subjects\n* To describe the immune responses to REVAXIS administered 1 and 6 months after the administration of REPEVAX in these subjects",[136,137,138,139],"Diphtheria","Tetanus","Poliomyelitis","Pertussis",[136,137,138,141,142],"Pertussis (acellular)","Biological\u002Fvaccine","COMPLETED","2017-09-08",{"date":146,"type":130},"2017-09-11",{"date":148,"type":130},"2011-01",{"date":150,"type":130},"2012-05",{"name":23,"class":6},12]