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Consistency study of GlaxoSmithKline (GSK) Biologicals’ MMR vaccine (209762) (Priorix®) comparing immunogenicity and safety to Merck & Co., Inc.’s MMR vaccine (M-M-R®II), in children 12 to 15 months o...

Mise à jour : Il y a 4 ans
Référence : EUCTR2011-004891-12

Consistency study of GlaxoSmithKline (GSK) Biologicals’ MMR vaccine (209762) (Priorix®) comparing immunogenicity and safety to Merck & Co., Inc.’s MMR vaccine (M-M-R®II), in children 12 to 15 months of age

Femme et Homme

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Extrait

•To demonstrate the consistency of three manufacturing lots of Inv_MMR vaccine in terms of seroresponse rates to measles, mumps and rubella viruses at Day 42. •To demonstrate the consistency of three manufacturing lots of Inv_MMR vaccine in terms of geometric mean concentrations (GMCs) for antibodies to measles, mumps and rubella viruses at Day 42. •To demonstrate the non-inferiority of Inv_MMR (for the three pooled lots) compared to Com_MMR (for the two pooled lots) vaccine in terms of seroresponse rates for measles, mumps and rubella viruses at Day 42. •To demonstrate non-inferiority of Inv_MMR (for the three pooled lots) compared to Com_MMR (for the two pooled lots) vaccine in terms of GMCs for antibodies to measles, mumps and rubella viruses at Day 42. •To demonstrate an acceptable immune response for Inv_MMR in terms of seroresponse rates for measles, mumps and rubella viruses at Day 42.

Critère d'inclusion

  • Healthy volunteers (Active immunization against measles, mumps and rubella diseases of healthy children in their second year of life)

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