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

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

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

Sponsors & Collaborators

• GlaxoSmithKline

  collaborator INDUSTRY

• Novartis Vaccines

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

12 Months

Max Age

24 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2009-07-31

Primary Completion

2011-08-31

Completion

2012-01-31

Countries

• Belgium
• Czechia
• Germany
• Italy
• Spain
• United Kingdom

Study Locations