NCT01148524

Assessment of Antibody Persistence at Eighteen Months After the Completion of the Vaccination Course in Study V72P10

A Phase 2b/3, Multi-Center, Extension Study of V72P10 to Assess Antibody Persistence at Eighteen Months After the Completion of the Vaccination Course in Study V72P10.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 817 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 13 Years – 19 Years
• Healthy volunteers: Accepted

Summary

This was a Phase 2b/3, multi-center, extension study of V72P10 to assess antibody persistence at 18 months after the vaccination course in study V72P10 (NCT00661713). Subjects who participated in study V72P10, and who meet all other enrollment criteria for this extension study, and a group of naïve subjects (defined as subjects who had never received rMenB+OMV NZ or other experimental MenB vaccines) of similar age to the subjects who were eligible to participate in this extension study, performed one study visit in which a single blood sample was drawn for MenB serological analyses.

Conditions

• Meningococcal Disease
• Meningococcal Meningitis

Interventions

Type	Name	Description
BIOLOGICAL	No Vaccine
BIOLOGICAL	rMenB+OMV-NZ	Subjects who had received either rMenB+OMV-NZ or placebo at study month 6 in V72P10 study had a blood sample drawn for serological analyses at 18 months later (-1/+3 months).

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2010-06-22
• Last updated: 2018-06-15
• Results posted: 2014-03-11

Locations

6 sites across 1 country: Chile