NCT01026974

Extension Study Evaluating Antibody Persistence and Safety, Tolerability and Immunogenicity of a Booster Dose of Novartis rMenB±OMV NZ Vaccine in Healthy UK Children Who Previously Received Three Doses of the Same Vaccine

A Phase 2, Open-Label, Single-Center, Extension Study Evaluating Antibody Persistence Compared to Naïve Children and Safety, Tolerability and Immunogenicity of a Booster Dose of Novartis rMenB±OMV NZ Vaccine in Healthy UK Children Who Previously Received a Three-Dose Series of the Novartis Vaccine as Infants in Study V72P9

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 40 Months – 62 Months
• Healthy volunteers: Accepted

Summary

The proposed study V72P9E1 is an Extension Study of V72P9. The objectives of this extension study will be to explore antibody persistence in children at approximately 40 months of age and to evaluate the safety, tolerability and immunogenicity of a booster dose of rMenB±OMV NZ administered to subjects at approximately 40 months of age. Antibody persistence will be subsequently measured at 18-20 months after these booster doses when the subjects are 60 months of age. Two groups of naïve subjects, aged approximately 40 and 60 months, will be recruited in the study to serve as a baseline comparator for assessing antibody persistence at these ages. These subjects will receive a two-dose catch-up regimen with rMenB+OMV NZ. Subjects who are enrolled at 40 months of age are offered DTaP/IPV and MMR vaccinations , if they have not already received these vaccines prior to enrollment.

Conditions

• Meningococcal Disease

Interventions

Type	Name	Description
BIOLOGICAL	rMenB
BIOLOGICAL	rMenB+OMV NZ

Timeline

• Start date: 2010-02-01
• Primary completion: 2010-09-01
• Completion: 2012-05-01
• First posted: 2009-12-07
• Last updated: 2014-10-01
• Results posted: 2014-03-11

Locations

1 site across 1 country: United Kingdom