NCT01210885

Immunogenicity and Safety of Different rMenB Plus MenACWY Formulations in Adolescents

Phase 2, Observer Blinded, Controlled, Randomized Multi-Center Study in Adolescents, to Evaluate Safety, Tolerability and Immunogenicity of Four Different rMenB Plus MenACWY Formulations

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 495 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 11 Years – 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this phase 2 study is to evaluate the safety, tolerability and immunogenicity of two doses of 4 different investigational MenABCWY combination vaccine when administered to healthy adolescents aged 11-18 years.

Conditions

• Meningococcal Disease
• Meningococcal Meningitis

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal Vaccine	MenABCWY combination vaccine containing four different rMenB formulations with MenACWY, intramuscular (IM) administration, vaccination at 0 and 2 months.

Timeline

• Start date: 2010-12-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2010-09-29
• Last updated: 2011-10-24

Locations

8 sites across 3 countries: Chile, Colombia, Panama