NCT01717638

Persistence of Antibody Levels and Response to Fifth or Third Meningococcal B Recombinant Vaccine in 4-year Old Healthy Children Who Previously Participated in Study V72P12E1

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 805 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 48 Months – 60 Months
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Meningococcal Disease
• Meningococcal Meningitis

Interventions

Type	Name	Description
BIOLOGICAL	1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine	0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, single dose
BIOLOGICAL	2 doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine	0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, two doses, two months apart

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-09-01
• Completion: 2013-10-01
• First posted: 2012-10-30
• Last updated: 2015-01-13
• Results posted: 2015-01-13

Locations

29 sites across 4 countries: Czechia, Italy, Spain, United Kingdom