CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 264 enrolled
Drug / intervention
Meningococcal B Recombinant vaccine rMenB+OMV NZ +2 morebiological
Likely dose
Meningococcal B Recombinant vaccine rMenB+OMV NZ 0.5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01973218
NCT01973218Phase 3Completed
CompareCT.gov

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

Novartis Vaccines·interventional·Posted Oct 31, 2013·Updated Oct 30, 2015

In Brief

A Phase 3 clinical trial evaluating Meningococcal B Recombinant vaccine rMenB+OMV NZ, Placebo, and 1 other intervention for Meningococcal Disease. Completed, enrolled 264 participants across 7 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeningococcal Disease
CountriesSouth Korea
CollaboratorsNovartis

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 31, 2013
Enrollment StartNov 1, 2013
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 12.7 years ago

Interventions

Meningococcal B Recombinant vaccine rMenB+OMV NZbiological

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.

Placebobiological

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.

Meningococcal ACWY-CRM conjugate vaccinebiological

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.