NCT00560313

Safety, Tolerability and Immunogenicity of Three Doses of Novartis Meningococcal B Vaccine When Administered to Healthy At-risk Adults

A Phase 2, Multi-Center, Open-label Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered at a 0, 2, 6-Month Schedule and of a Single Dose of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy At-risk Adults 18-50 Years of Age

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study is aimed to evaluate safety, tolerability and immunogenicity of three doses of Novartis 4CMenB and of one dose of Novartis Meningococcal ACWY vaccine when administered to healthy at-risk adults.

Conditions

• Meningococcal Disease

Interventions

Type	Name	Description
BIOLOGICAL	Men ACWY CRM	A single dose of a 0.5 mL injectable solution
BIOLOGICAL	4CMenB	All subjects received the study vaccine following a 0,2,6 vaccination schedule. Pre-filled syringe, administered by intramuscular injection into the deltoid area of the non dominant arm.

Timeline

• Start date: 2007-07-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2007-11-19
• Last updated: 2016-04-01
• Results posted: 2011-07-08

Locations

1 site across 1 country: Italy