NCT01027351

Extension Study Evaluating Antibody Persistence and Safety, Tolerability and Immunogenicity of Booster Doses of Novartis rMenB±OMV NZ Vaccine in Healthy UK Children Who Previously Received One or Four 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 Booster Doses of Novartis rMenB±OMV NZ Vaccine in Healthy UK Children Who Previously Received One or Four Doses of the Novartis Vaccine as Infants in Study V72P6

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 163 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 40 Months – 62 Months
• Healthy volunteers: Accepted

Summary

The proposed study V72P6E1 is an Extension Study of V72P6 (NCT00381615). The objectives of this extension study will be to explore antibody persistence at approximately 40 months of age and to evaluate the safety, tolerability and immunogenicity of booster doses 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	Meningococcal (group B) multicomponent recombinant adsorbed vaccine.	Subjects received either one or two booster doses of the same vaccine they had received in the parent trial (rMenB+OMV NZ) or two catch-up doses.
BIOLOGICAL	Meningococcal (group B) multicomponent recombinant adsorbed vaccine, without Outer Membrane Vesicles (OMV)	Subjects received either one or two booster doses of the same vaccine they had received in the parent trial (rMenB).

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-09-01
• Completion: 2012-05-01
• First posted: 2009-12-07
• Last updated: 2018-10-09
• Results posted: 2014-05-06

Locations

1 site across 1 country: United Kingdom