NCT01339923

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,409 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 71 Days – 10 Years
• Healthy volunteers: Accepted

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.

Conditions

• Meningococcal Disease
• Meningococcal Meningitis

Interventions

Type	Name	Description
BIOLOGICAL	rMenB + OMV NZ vaccine	3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)
BIOLOGICAL	rMenB + OMV NZ vaccine	2 doses (3.5, 5 months of age) plus booster (11 months of age)
BIOLOGICAL	rMenB + OMV NZ vaccine	2 doses (6, 8 months of age) plus booster (11 months of age)
BIOLOGICAL	rMenB + OMV NZ vaccine	2 doses 2 months apart
BIOLOGICAL	Meningococcal C oligosaccharide conjugated vaccine	Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine
BIOLOGICAL	Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.	Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.
BIOLOGICAL	rMenB + OMV NZ vaccine	Schedule 3, 5, 12 rMenB + OMV vaccine
BIOLOGICAL	rMenB + OMV NZ vaccine	Schedule 13,15 rMenB + OMV vaccine

Timeline

• Start date: 2011-04-01
• Primary completion: 2014-01-01
• Completion: 2014-12-01
• First posted: 2011-04-21
• Last updated: 2016-05-09
• Results posted: 2016-01-20

Locations

26 sites across 4 countries: Brazil, Hungary, Peru, Spain