NCT00847145

Extension Study of V72P13 to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster or as a Two-dose Catch-up to Healthy Toddlers

A Phase 3, Open Label, Multi-Center, Extension Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster at 12 Months of Age or as a Two-dose Catch-up to Healthy Toddlers Who Participated in Study V72P13

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,249 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 365 Days – 394 Days
• Healthy volunteers: Accepted

Summary

The proposed study is an Extension Study of V72P13 to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster at 12 Months of Age or as a Two-dose Catch-up to Healthy Toddlers

Conditions

• Meningococcal Disease

Interventions

Type	Name	Description
BIOLOGICAL	1a - rMenB+OMV NZ and routine vaccines	One dose of rMenB vaccine and routine vaccine at study month 12.
BIOLOGICAL	1b - rMenB+OMV NZ and routine vaccines	One dose of rMenB vaccine at study month 12 and routine vaccine at study month 13.
BIOLOGICAL	2a - Routine and rMenB+OMV NZ vaccines	One dose of routine vaccine at study month 12 and two doses of rMenB vaccine at study months 13 and 15.
BIOLOGICAL	2b - rMenB+OMV NZ and routine vaccines	Two doses of rMenB vaccine at study months 12 and 14 and one dose of routine vaccine at study month 12.
BIOLOGICAL	3a - rMenB+OMV NZ and routine vaccines	One dose of rMenB vaccine and one dose of routine vaccine at study month 12.
BIOLOGICAL	3b - 1 dose of rMenB+OMV NZ plus routine infant vaccinations	One dose of rMenB vaccine at study month 12 and one dose of routine vaccine study month 13.
BIOLOGICAL	4a- rMenB+OMV NZ and routine vaccines	One dose of rMenB vaccine and one dose of routine vaccine at study month 12.
BIOLOGICAL	4b - rMenB+OMV NZ and routine vaccines	One dose of rMenB vaccine and one dose of routine vaccine at study month 12.

Timeline

• Start date: 2009-02-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2009-02-19
• Last updated: 2015-03-03
• Results posted: 2015-03-03

Locations

59 sites across 5 countries: Austria, Czechia, Finland, Germany, Italy