NCT00974363

Study to Evaluate Persistence of Antibodies After Vaccination With Meningococcal Vaccine GSK 134612

Persistence of Antibodies After Vaccination With GSK Biologicals' Meningococcal Vaccine GSK134612 in Adolescents and Young Adults

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 697 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 11 Years – 17 Years
• Healthy volunteers: Accepted

Summary

Subjects were previously vaccinated at 11 to 17 years of age. This extension phase starts 24 months after vaccination and the subjects who were vaccinated in the primary study will be enrolled in this extension phase. No new subjects will be enrolled.

Detailed description

Subjects were previously vaccinated at 11 to 17 months of age with GSK Biologicals' meningococcal vaccine 134612 or with Mencevax™. This extension phase starts 24 months after vaccination and the subjects who were vaccinated in the primary study will be enrolled in this extension phase. No new studies will be enrolled. The subjects will have 4 blood samples taken: at 24, 36, 48 and 60 months after vaccination.

Conditions

• Infections, Meningococcal

Interventions

Type	Name	Description
PROCEDURE	Blood Sampling	A blood sample will be taken yearly at each long-term follow-up visit (i.e. Year 2 through Year 5) after vaccination during the primary study. No vaccines are administered in the long-term follow-up study

Timeline

• Start date: 2009-09-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2009-09-10
• Last updated: 2017-04-12
• Results posted: 2017-04-12

Locations

5 sites across 2 countries: India, Philippines