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A phase II, open, randomised, comparative study to evaluate the immunogenicity and safety of GlaxoSmithKline's (GSK) Biologicals' measles-mumps-rubella-varicella candidate vaccine (MeMuRu-OKA) and GSK...

Mise à jour : Il y a 4 ans
Référence : EUCTR2005-006065-14

A phase II, open, randomised, comparative study to evaluate the immunogenicity and safety of GlaxoSmithKline's (GSK) Biologicals' measles-mumps-rubella-varicella candidate vaccine (MeMuRu-OKA) and GSK Biologicals' measles-mumps-rubella vaccine (Priorix) co-administered in separate injections with GSK Biologicals' varicella vaccine (Varilrix) when given in healthy children who previously received a first dose of an MMR vaccine

Femme et Homme

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Extrait

• To demonstrate the non-inferiority of MeMuRu-OKA vaccine to Priorix and Varilrix vaccines administered as separate injections in terms of varicella seroconversion rate 42-56 days after the first vaccination in initially seronegative subjects. • To demonstrate the non-inferiority of MeMuRu-OKA vaccine to Priorix and Varilrix vaccines administered as separate injections in terms of measles, mumps and rubella geometric mean titers (GMTs) 42-56 days after the first vaccination.

Critère d'inclusion

  • Healthy male and female children between 15 months and 6 years of age who previously received an MMR vaccine will receive one dose of MMR + V or MMRV. A second dose of varicella vaccine will be given to all subjects

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