NCT02798952

A Study to Evaluate Persistence of Hepatitis B Antibodies, Immunogenicity and Safety of Engerix™-B Kinder Challenge Dose, in Adolescents Vaccinated With Four Doses of Infanrix™ Hexa During Infancy

Persistence of Hepatitis B Antibodies, Immunogenicity and Safety of GlaxoSmithKline (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: 302 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 14 Years – 15 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 14-15 years who were vaccinated with four doses of Infanrix™-Hexa in the first two years of life 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	Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 14-15 years of age.

Timeline

• Start date: 2016-08-23
• Primary completion: 2017-07-05
• Completion: 2017-07-05
• First posted: 2016-06-14
• Last updated: 2020-01-18
• Results posted: 2019-02-01

Locations

14 sites across 1 country: Germany