NCT02052661

This Study Aims to Determine the Long-term Persistence of Antibodies Against Hepatitis B and to Evaluate the Immunogenicity and Safety of Hepatitis B Vaccine in Adolescents Vaccinated in Infancy With Infanrix™ Hexa

Persistence of Hepatitis B Antibodies, Immunogenicity and Safety of GSK Biologicals' Hepatitis B Vaccine Engerix™-B Kinder (SKF103860) Challenge Dose in Adolescents Vaccinated With Four Doses of Infanrix™ Hexa (SB217744) During Infancy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 301 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 12 Years – 13 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the long-term persistence of immunity to hepatitis B in adolescents aged 12-13 years who were vaccinated with four doses of Infanrix™-Hexa in infancy and to assess the anamnestic response, immunogenicity, safety and reactogenicity of a single challenge dose of the hepatitis B vaccine Engerix™-B Kinder.

Conditions

• Hepatitis B

Interventions

Type	Name	Description
BIOLOGICAL	Engerix™-B Kinder	Single dose administered intramuscularly in deltoid region of non-dominant arm.

Timeline

• Start date: 2014-02-18
• Primary completion: 2014-09-23
• Completion: 2014-09-23
• First posted: 2014-02-03
• Last updated: 2018-06-06
• Results posted: 2015-08-27

Locations

11 sites across 1 country: Germany