CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 128 enrolled
Drug / intervention
MenACWYbiological
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/NCT02446691
NCT02446691Phase 4Completed
CompareCT.gov

A Phase IV, Open-Label, Multi-Center Study to Evaluate the Safety and the 1-year Persistence of Antibody Response Among Children Who Received 4 Doses of the GSK MenACWY Conjugate Vaccine at 2, 4, 6 and 12 Months of Age in South Korea

GlaxoSmithKline·interventional·Posted May 18, 2015·Updated Jun 27, 2019

In Brief

A Phase 4 clinical trial evaluating MenACWY for Infections, Meningococcal. Completed, enrolled 128 participants across 6 sites.

Detailed Summary

This is Phase IV, Open label, Multicenter study. Subject's parents and/or legal guardian will be provided information about the trial. If interested and if eligible, they will then be asked to provide signed informed consent. The initial study visit can occur immediately after signed informed consent has been obtained. Approximately 135 subjects will be enrolled to receive 4 doses of intramuscular MenACWY vaccine at 2, 4, 6 and 12 months of age.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Meningococcal
CountriesSouth Korea
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 18, 2015
Enrollment StartJul 13, 2015
Primary CompletionDec 28, 2017
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 11.1 years ago

Interventions

MenACWYbiological

Four Intramuscular doses of MenACWY vaccine at 2, 4, 6 and 12 months of age followed by two blood samples at 13 and 24 months of age.