Meningococcal Disease Clinical Trial
Official title:
A Phase 3, Open Label, Multi-Center, Extension Study to Assess Antibody Persistence and Response to a Third or Fifth Dose of Novartis Meningococcal B Recombinant Vaccine in 4-Year-Old Children Who Previously Participated in Study V72P12E1
It is a Phase 3 extension of study V72P12E1 (NCT00944034). The main aim of the second
extension study is to explore the bactericidal antibody persistence in 4-year-old children
after a fourth dose boost of rMenB+OMV NZ or after a two-dose catch-up schedule of rMenB+OMV
NZ administered to toddlers as part of their respective vaccination courses in study
V72P12E1.
In addition, this study will characterize the antibody response to a fifth dose boost in all
children who received a three-dose primary series of rMenB+OMV NZ at 2, 3, 4 months of age
(in parent study V72P12, NCT00721396), and only in a subset of children who received a
three-dose primary series of rMenB+OMV NZ at 2, 4, 6 months of age (in parent study V72P12).
Antibody response will also be characterized to a third dose boost of rMenB+OMV NZ
administered at approximately 4 years of age in all children who received a two catch-up
doses of rMenB+OMV NZ as toddlers in study V72P12E1.
Finally, the safety and immunogenicity of two catch-up doses of rMenB+OMV NZ administered 2
months apart to healthy naïve children at 4 years of age will be assessed.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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