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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 dipht...

Update Il y a 4 ans
Reference: EUCTR2010-023086-21

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

Woman and Man

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Extract

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. To evaluate the percentage of subjects with antibody titre ≥5 EU/mL (ELISA) for each of the pertussis components (PT, FHA, PRN and FIM) after 1 dose of REPEVAX in these subjects.

Inclusion criteria

  • Evaluation of 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®),The MedDRA term corresponding to classification code 10069577 is Pertussis immunisation

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