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A phase IV, open, non-randomized, multicentre study to assess the reactogenicity and immunogenicity of a booster dose of GSK Biologicals’ combined reduced-antigen-content diphtheria, tetanus and acell...

Mise à jour : Il y a 4 ans
Référence : EUCTR2009-016012-21

A phase IV, open, non-randomized, multicentre study to assess the reactogenicity and immunogenicity of a booster dose of GSK Biologicals’ combined reduced-antigen-content diphtheria, tetanus and acellular pertussis vaccine dTpa (Boostrix™) when administered in healthy adult subjects, after previous booster vaccination with dTpa in study 263855/029 (dTpa-029)

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Extrait

•To assess the persistence of anti-diphtheria, anti-tetanus, anti-PT, anti-FHA, and anti-PRN antibodies 8.5 and 10 years after the previous booster dose in study 263855/029 (dTpa-029). •To assess the immunogenicity of the administered dTpa vaccine in terms of antibody response to all vaccine antigens, one month after a second booster vaccination in subjects who will receive: the dTpa-0.5 vaccine and have previously received the same vaccine. the dTpa-0.3 vaccine and have previously received the same vaccine. the dTpa-0.5 vaccine and have previously received the dTpa-0.133 vaccine.

Critère d'inclusion

  • Immune persistence and booster immunisation against diphtheria, tetanus and pertussis in adults

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