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Title of the trial: A Phase 3, Open-Label, Multi-Center, Extension Study of V72P13E1 to Assess Antibody Persistence at One Year After a Fourth Dose Boost or Two Catch-Up Doses of Novartis Meningococca...

Mise à jour : Il y a 4 ans
Référence : EUCTR2009-018101-52

Title of the trial: A Phase 3, Open-Label, Multi-Center, Extension Study of V72P13E1 to Assess Antibody Persistence at One Year After a Fourth Dose Boost or Two Catch-Up Doses of Novartis Meningococcal B Recombinant Vaccine Administered Starting at 12 Months of Age and to Evaluate the Response to a Third Dose Boost or Two Catch-Up Doses Starting at 24 Months of Age

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Extrait

Immunogenicity :To explore antibody persistence at one year after a booster (fourth) dose of rMenB+OMV NZ, administered at 12 months of age to toddlers enrolled in study V72P13E1 who previously received a three-dose primary series of rMenB+OMV NZ (administered at 2, 4 and 6 months of age) as infants in the original parent study V72P13. Safety:a.To assess the safety and tolerability of a booster (third) dose of rMenB+OMV NZ administered at one year after two catch-up doses of rMenB+OMV NZ, previously administered to toddlers at either 12 and 14 or 13 and 15 months of age in study V72P13E1.plus assess the safety and tolerability of two catch-up doses of rMenB+OMV NZ administered to naïve children at 24 and 26 months of age.

Critère d'inclusion

  • Groups 1a, 1b, 2a and 2b: From the last study visit in V72P13E1 to the start of the study V72P13E2 (Day 1):assessment of immunogenicity or safety Group 3: From birth to the start of the study V72P13E2 (Day 1), 30 minutes after each vaccination:Immediate reactions, For 7 days after each vaccination: body temperature

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