Study to evaluate immunogenicity and safety of GSK Biologicals’ measles, mumps, rubella and varicella (MMRV) freezer-stored (MMRVF) & refrigerator-stored (MMRVR) vaccine formulations vs. ProQuad in infants 12-14 months of age when co-administered with hepatitis A and pneumococcal conjugate vaccines

Conditions

• Healthy volunteers (Use of the candidate MMRV vaccine for immunization of healthy children 12 - 14 months of age against measles, mumps, rubella and varicella)

Interventions

• Havrix 720 Junior

Lay summary

• To demonstrate the non-inferiority of GSK Biologicals’ MMRVR co-administered with HAV and PCV compared to ProQuad co-administered with HAV and PCV at Day 42 with respect to - the seroresponse rate for antibodies to -> varicella virus -> measles virus and rubella virus -> mumps virus - the geometric mean concentration (GMC) for anti-bodies to -> varicella virus -> hepatitis A virus in a subset of subjects -> S. pneumoniae serotypes (anti-PS) 4, 6B, 9V, 14, 18C, 19F and 23F in a subset of subjects • To demonstrate the non-inferiority of GSK Biologicals’ MMRVF co-administered with HAV and PCV compared to ProQuad co-administered with HAV and PCV at Day 42 with respect to - the seroresponse rate for antibodies to -> varicella virus -> measles virus and rubella virus -> mumps virus - GMC for antibodies to -> varicella virus -> hepatitis A virus in a subset of subjects -> anti-PS serotypes 4, 6B, 9V, 14, 18C, 19F and 23F in a subset of subjects

Documents

Publications

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Registries

• EU Clinical Trials Register