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A Phase III, Multi-Center, Open-Label, Controlled, Randomized Study to Evaluate the Immunogenicity, Safety, Tolerability and the Ability to Prime for Memory of Chiron Meningococcal C Conjugate Vaccine...

Mise à jour : Il y a 4 ans
Référence : EUCTR2005-000924-18

A Phase III, Multi-Center, Open-Label, Controlled, Randomized Study to Evaluate the Immunogenicity, Safety, Tolerability and the Ability to Prime for Memory of Chiron Meningococcal C Conjugate Vaccine Menjugate® When Administered to Healthy Infants as One Dose Given at 2 or 6 Months of Age with a Booster at 12-16 Months of Age, in Comparison to Two Doses in the First Year of Life, Given Two Months Apart, With a Booster at 12-16 Months of Age;

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Extrait

To demonstrate non-inferiority, 10 days after the booster vaccination, of the memory antibody response (in terms of percent responders) to Neisseria meningitidis serogroup C after 1 dose of Menjugate® at 2 months of age plus a booster in the second year of life (study group 2) in comparison with the memory antibody response after 2 doses of Menjugate at 2 and 4 months of age plus a booster in the second year of life (study group 1), as measured by bactericidal assay using rabbit complement (rBCA).

Critère d'inclusion

  • Healthy subjects without known medical conditions will be vaccinated against N. menigitidis serogroup C. Active prevention of menigococcal C disease caused by Neisseria menigitidis

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