NCT02446691

Evaluation of Antibody Persistence Following 4 MenACWY Vaccinations

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 2 Months – 24 Months
• Healthy volunteers: Accepted

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.

Conditions

• Infections, Meningococcal

Interventions

Type	Name	Description
BIOLOGICAL	MenACWY	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.

Timeline

• Start date: 2015-07-13
• Primary completion: 2017-12-28
• Completion: 2017-12-28
• First posted: 2015-05-18
• Last updated: 2019-06-27
• Results posted: 2019-04-01

Locations

6 sites across 1 country: South Korea