NCT01272180

Safety and Immunogenicity of Different Meningitis Vaccine Formulations in Adolescents and Young Adults

Phase 2, Observer Blinded, Controlled, Randomized Multi-Center Study in Adolescents and Young Adults to Evaluate Safety and Immunogenicity of Two Different rMenB With OMV + MenACWY Combination Vaccination Formulations

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 484 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 10 Years – 25 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the safety and immunogenicity of combination vaccines as compared to the reference vaccines

Conditions

• Invasive Meningococcal Disease

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal (groups A, C, W, Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine + OMV.	Two injections of a combined vaccine formulation, Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus OMV.
BIOLOGICAL	Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus OMV.	Two injections of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus OMV.
BIOLOGICAL	Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine.	One injection of saline solution placebo and one of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine.
BIOLOGICAL	Meningococcal (groups A, C, W, Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine + qOMV.	Two injections of a combined vaccine formulation, Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus a quarter dose of OMV.

Timeline

• Start date: 2011-08-01
• Primary completion: 2011-10-01
• Completion: 2012-09-01
• First posted: 2011-01-07
• Last updated: 2020-06-16
• Results posted: 2014-09-26

Locations

13 sites across 2 countries: United States, Poland