CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 3,948 enrolled
Drug / intervention
MenACWY-CRM (Menveo)biological
Likely dose
Not stated in 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/NCT01766206
NCT01766206Phase 4Completed
CompareCT.gov

A Multicenter Post Marketing Surveillance Study to Monitor the Safety of GlaxoSmithKline (GSK) Biologicals' Meningococcal ACWY Conjugate Vaccine(MenACWY-CRM) Administered According to the Prescribing Information to Healthy Subjects From 2 Months to 55 Years of Age in the Republic of South Korea.

GlaxoSmithKline·interventional·Posted Jan 11, 2013·Updated Sep 21, 2018

In Brief

A Phase 4 clinical trial evaluating MenACWY-CRM (Menveo) for Meningococcal Disease. Completed, enrolled 3,948 participants across 54 sites.

Detailed Summary

A multicenter, single arm, post-marketing surveillance study. This study is a postlicensure requirement of the Korea Food and Drug Administration (KFDA) to provide continued safety evaluation of MenACWY in the Korean population from 2 months to 55 years of age, receiving MenACWY-CRM vaccination according to routine clinical practice and prescribing information.

Study Details

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

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 11, 2013
Enrollment StartMar 15, 2013
Primary CompletionJan 22, 2018
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 13.5 years ago

Interventions

MenACWY-CRM (Menveo)biological

One dose administered intramuscularly preferably into the anterolateral aspect of the thigh in infants or into the deltoid muscle in children, adolescents and adults.