Immunogenicity and safety study of GlaxoSmithKline (GSK) Biologicals’ combined measles-mumps-rubella (MMR) vaccine in children in their second year of life. GlaxoSmithKline (GSK) Biologicalsin t...

Update Il y a 4 ans
Reference: EUCTR2011-004905-26

Immunogenicity and safety study of GlaxoSmithKline (GSK) Biologicals’ combined measles-mumps-rubella (MMR) vaccine in children in their second year of life. GlaxoSmithKline (GSK) Biologicalsin tuhkarokko-sikotautivihurirokkorokotteen (MMR) immunogeenisuus- ja turvallisuustutkimus lapsilla toisen ikävuoden aikana

Woman and Man

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Extract

•To demonstrate non-inferiority of Inv_MMR vaccine compared to pooled Com_MMR vaccine lots in terms of seroresponse rates to MMR viruses at Day 42. •To demonstrate non-inferiority of Inv_MMR vaccine compared to pooled Com_MMR vaccine lots in terms of geometric mean concentrations (GMCs) for antibodies to MMR viruses at Day 42. •To demonstrate an acceptable immune response of Inv_MMR vaccine in terms of seroresponse rates for MMR viruses at Day 42. •To demonstrate non-inferiority of the Inv_MMR vaccine compared to pooled Com_MMR vaccine lots in terms of seroresponse rates for mumps virus (by Plaque Reduction Neutralization Test (PRNT)) at Day 42. •To demonstrate non-inferiority of the Inv_MMR vaccine compared to pooled Com_MMR vaccine lots in terms of geometric mean titer (GMT) for antibodies to mumps virus (by PRNT) at Day 42.


Inclusion criteria

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