NCT01894919

Antibody Persistence, and Safety and Tolerability of a Booster Dose of the Meningococcal B Vaccine After the Completion of the Vaccination Course in Study V72_28

A Phase IIIb, Open Label, Multi Center Extension Study of V72_28 to Assess Antibody Persistence, and the Safety and Tolerability of a Booster Dose After the Completion of the Vaccination Course in Study V72_28

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 851 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 35 Months – 12 Years
• Healthy volunteers: Accepted

Summary

The aim of this extension study is to explore the antibody persistence 24 to 36 months after the last dose of vaccine, in infants that received a two or three dose primary series plus a booster dose at 11 months of age, of the Novartis meningococcal B vaccine (Bexsero®) in groups I to III of the parent V72\_28 study. This study will also explore the antibody persistence 24 to 36 months after two catch-up doses of the Novartis meningococcal B vaccine (Bexsero®) administered in children (2 to 10 years old) in group IV of the parent V72\_28 study.

Conditions

• Meningoccocal Disease
• Meningococcal Meningitis

Interventions

Type	Name	Description
BIOLOGICAL	Bexsero® vaccine (1 dose at study month zero)
BIOLOGICAL	Bexsero® vaccine (2 doses 1 month apart)

Timeline

• Start date: 2013-06-01
• Primary completion: 2015-09-01
• Completion: 2015-11-01
• First posted: 2013-07-10
• Last updated: 2021-11-30
• Results posted: 2018-12-07

Locations

17 sites across 2 countries: Hungary, Spain