NCT00944034

Safety, Tolerability and Immunogenicity of Meningococcal B Recombinant Vaccine Administered as Booster Dose at 12, 18 or 24 Months of Age in Toddlers (12-24 Months) Primed With a Three-Dose Immunization Series as Infants in Study V72P12

A Phase 2b, Open Label, Multi-Center, Extension Study to Evaluate the Safety, Tolerability and Immunogenicity of a Booster Dose of Novartis Meningococcal B Recombinant Vaccine Administered at 12, 18 or 24 Months of Age in Subjects Who Previously Received a Three-Dose Primary Series of the Novartis Meningococcal B Recombinant Vaccine as Infants in Study V72P12

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 1,588 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 12 Months – 24 Months
• Healthy volunteers: Accepted

Summary

This extension study V72P12E1 will investigate the safety, tolerability and immunogenicity of a fourth (booster) dose of rMenB+OMV NZ at 12, 18 and 24 months of age in subjects previously primed with rMenB+OMV NZ according to two different three-dose immunization schedules in infancy (2, 4 and 6 or 2, 3 and 4 months of age in the parent study V72P12). The study will also explore the bactericidal antibody persistence at 12, 18 and 24 months of age, following the two different immunization schedules, in order to identify the optimal timing for boosting. Two catch-up rMenB+OMV NZ doses will be given to unprimed, naïve toddlers at 12 (subjects enrolled in the control group of V72P12), 18 and 24 months of age (two new cohort of subjects enrolled). These subjects will generate data for assessing the safety and immunogenicity of a two-dose catch-up regimen at these ages, but will also serve as controls for a descriptive comparison of antibody persistence and booster responses for the other groups.

Conditions

• Meningococcal Disease
• Meningococcal Meningitis

Interventions

Type	Name	Description
BIOLOGICAL	rMenB+OMV NZ with routine vaccinations	rMenB+OMV NZ with routine vaccinations at 2, 4, and 6 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 12 months of age
BIOLOGICAL	rMenB+OMV NZ with routine vaccinations	rMenB+OMV NZ with routine vaccinations at 2, 4, and 6 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 18 months of age
BIOLOGICAL	rMenB+OMV NZ	rMenB+OMV NZ at 2, 4, and 6 months of age and routine vaccinations at 3, 5 and 7 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 12 months of age
BIOLOGICAL	rMenB+OMV NZ	rMenB+OMV NZ at 2, 4, and 6 months of age and routine vaccinations at 3, 5 and 7 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 18 months of age
BIOLOGICAL	rMenB+OMV NZ with routine vaccinations	rMenB+OMV NZ with routine vaccinations at 2, 3 and 4 months of age; random allocation in a 1:1:1 ratio to receive 1 booster dose of rMenB+OMV NZ at 12 months of age
BIOLOGICAL	rMenB+OMV NZ with routine vaccinations	rMenB+OMV NZ with routine vaccinations at 2, 3 and 4 months of age; random allocation in a 1:1:1 ratio to receive 1 booster dose of rMenB+OMV NZ at 18 months of age
BIOLOGICAL	two doses of rMenB+OMV NZ	two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age.
BIOLOGICAL	rMenB+OMV NZ with routine vaccinations	rMenB+OMV NZ with routine vaccinations at 2, 4, and 6 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 24 months of age
BIOLOGICAL	two doses of rMenB+OMV NZ	two catch-up doses of rMenB+OMV NZ at 18 and 20 months of age
BIOLOGICAL	rMenB+OMV NZ	rMenB+OMV NZ at 2, 4, and 6 months of age and routine vaccinations at 3, 5 and 7 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 24 months of age
BIOLOGICAL	two doses of rMenB+OMV NZ	two catch-up doses of rMenB+OMV NZ at 24 and 26 months of age
BIOLOGICAL	rMenB+OMV NZ with routine vaccinations	rMenB+OMV NZ with routine vaccinations at 2, 3 and 4 months of age; random allocation in a 1:1:1 ratio to receive 1 booster dose of rMenB+OMV NZ at 12 (Group 3a), 18 (Group 3b) or 24 (Group 3c) months of age

Timeline

• Start date: 2009-07-01
• Primary completion: 2011-08-01
• Completion: 2012-01-01
• First posted: 2009-07-22
• Last updated: 2017-08-14
• Results posted: 2015-11-10

Locations

72 sites across 6 countries: Belgium, Czechia, Germany, Italy, Spain, United Kingdom