NCT00937521

Safety and Immunogenicity in Dose-Ranging and Formulation-Finding Meningococcal B (MenB) Vaccine Study in 2-month-old Infants

A Phase 2 Partially Observer-Blind Randomized Controlled Multicenter Dose-Ranging and Formulation-Finding Study of a New Novartis Meningococcal B Recombinant Vaccine Evaluating the Safety and Immunogenicity When Given Concomitantly With Routine Vaccines in 2-month-old Infants

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,507 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 55 Days – 89 Days
• Healthy volunteers: Accepted

Summary

This study is aimed at assessing the safety and immunogenicity of different doses and formulations of a new Novartis Meningococcal B Recombinant Vaccine.

Conditions

• Meningococcal Meningitis
• Meningococcal Infections

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal B vaccine	Vaccine candidate formulation I
BIOLOGICAL	Meningococcal B vaccine	Vaccine candidate formulation II
BIOLOGICAL	Meningococcal B vaccine	Vaccine candidate formulation III
BIOLOGICAL	Meningococcal B vaccine	Vaccine candidate formulation IV
BIOLOGICAL	Meningococcal B vaccine	Vaccine candidate formulation V
BIOLOGICAL	Meningococcal B vaccine	Vaccine candidate formulation VI
BIOLOGICAL	Control	Control
BIOLOGICAL	Meningococcal B vaccine with antipyretic	Vaccine candidate formulation I with antipyretic

Timeline

• Start date: 2009-07-01
• Primary completion: 2010-11-01
• Completion: 2012-02-01
• First posted: 2009-07-13
• Last updated: 2015-04-07
• Results posted: 2015-03-04

Locations

38 sites across 5 countries: Argentina, Chile, Czechia, Hungary, Italy