Meningococcal Disease Clinical Trial
Official title:
A Phase 3B, Open Label, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered Alone to Healthy Infants According to Different Immunization Schedules and to Healthy Children Aged 2 to 10 Years
The proposed study is aimed at assessing the safety and immunogenicity of rMenB+OMV NZ when
administered alone without routine infant vaccines to healthy infants in their first year of
life according to different two and three dose immunization schedules, which are suitable to
be adopted by various national programs. This study will also investigate antibody
persistence post primary series and administration of a subsequent booster dose of rMenB+OMV
NZ at 11 months of age. In addition, this study will assess the safety and immunogenicity of
two catch-up doses of rMenB+OMV NZ when administered to healthy children 2 to 10 years of
age.
This study will also evaluate the safety and immunogenicity of the concomitant
administration of rMenB+OMV NZ with meningococcal C conjugate vaccine (MenC-CRM) according
to a 3, 5 and 12-month schedule.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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