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A phase III, open-label, randomised multicentre study to evaluate the immunogenicity and safety of a booster dose of GlaxoSmithKline Biologicals’ dTpa-IPV vaccine (Boostrix Polio) compared with Sanofi...

Mise à jour : Il y a 4 ans
Référence : EUCTR2009-012202-39

A phase III, open-label, randomised multicentre study to evaluate the immunogenicity and safety of a booster dose of GlaxoSmithKline Biologicals’ dTpa-IPV vaccine (Boostrix Polio) compared with Sanofi Pasteur MSD’s dTpa-IPV vaccine (Repevax), when co-administered with GSK Biologicals’ MMR vaccine (Priorix) in 3 and 4-year-old healthy children

Femme et Homme

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Extrait

• To demonstrate that GSK Biologicals’ dTpa-IPV vaccine is non-inferior to Sanofi Pasteur MSD’s dTpa-IPV vaccine in terms of percentages of subjects with immune response to the diphtheria, tetanus and polio antigens, one month after booster vaccination. • To demonstrate that GSK Biologicals’ dTpa-IPV vaccine given as a single booster dose in this study is non-inferior to GSK Biologicals’ DTPa vaccine (Infanrix) given as a primary series in the German household contact study APV-039 in terms of anti- PT, anti-FHA and anti-PRN geometric mean concentrations (GMCs), one month after booster vaccination.

Critère d'inclusion

  • Booster immunisation against diphtheria, tetanus, pertussis, poliomyelitis, measles, mumps and rubella in healthy preschool children previously vaccinated with 3 doses of DTPa and polio vaccine

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