At a glance
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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
In Brief
A Phase 3 clinical trial evaluating rMenB + OMV NZ vaccine, Meningococcal C oligosaccharide conjugated vaccine, and 1 other intervention for Meningococcal Disease and Meningococcal Meningitis. Completed, enrolled 1,409 participants across 26 sites in 4 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)
2 doses (3.5, 5 months of age) plus booster (11 months of age)
2 doses (6, 8 months of age) plus booster (11 months of age)
2 doses 2 months apart
Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine
Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.
Schedule 3, 5, 12 rMenB + OMV vaccine
Schedule 13,15 rMenB + OMV vaccine