An open-label, randomised, comparative, multi-centre study of the immunogenicity and safety of a 2-dose regimen of ProQuad® manufactured with rHA administered to healthy children from 9 months of age

Mise à jour : Il y a 4 ans
Référence : EUCTR2007-002468-88

Femme et Homme

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Extrait

The first primary objective is to demonstrate that a 2-dose regimen of ProQuad® rHA administered at a 3-month interval to healthy childrenof 11 months of age at the time of Dose 1 is as immunogenic as in healthy children of 12 months of age at the time of Dose 1, in terms of antibody response rates to measles, mumps, rubella and varicella at Day 42 following Dose 2. The second primary objective, only if the first primary objective is reached, is similar to the first one at 9 months of age. To demonstrate that a 2-dose regimen of ProQuad® rHA administered at a 3-month interval to healthy children of 11 months of age and 9 months of age at the time of Dose 1 is well tolerated compared to healthy children of 12 months of age at the time of Dose 1.


Critère d'inclusion

  • Measles, mumps, rubella and varicella vaccine administered to healthy children from 9 months of age