NCT01973218

Safety and Immunogenicity Study of Two Doses of Novartis Meningococcal Serogroup B Recombinant Vaccine in Adolescents Aged 11-17 Years.

A Phase 3, Randomized, Observer-blind, Multicenter Study to Evaluate the Immunogenicity and Safety of Novartis rMenB+OMV NZ Vaccine in Healthy Subjects Aged 11 to 17 Years in Korea

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 264 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 11 Years – 17 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study was to assess the immunogenicity and safety of two doses of Novartis Meningococcal B Recombinant (rMenB+OMV NZ) vaccine administered one month apart (0, 1 month schedule) in Korean adolescents aged between 11 to 17 years.

Conditions

• Meningococcal Disease

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal B Recombinant vaccine rMenB+OMV NZ	Subjects were randomized to one of two treatment groups to receive intramuscular (IM) vaccination with two doses of rMenV+OMV NZ vaccine (0.5 mL) in the non-dominant arm, one month apart. Subjects were followed for two months.
BIOLOGICAL	Placebo	Subjects were randomized to one of two treatment groups to receive intramuscular (IM) injection of saline solution followed by one dose of MenACWY-CRM vaccine (0.5 mL), one month apart. Subjects were followed for two months.
BIOLOGICAL	Meningococcal ACWY-CRM conjugate vaccine	Subjects were randomized to one of two treatment groups to receive intramuscular (IM) injection of saline solution followed by one dose of MenACWY-CRM vaccine (0.5 mL), one month apart. Subjects were followed for two months.

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2013-10-31
• Last updated: 2015-10-30
• Results posted: 2015-03-06

Locations

7 sites across 1 country: South Korea