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Evaluation of the Long-term Persistence of Immunity to Hepatitis B, in Adolescents Vaccinated in Infancy With Engerixâ„¢-B Kinder

NCT01847430 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 303

Last updated 2018-08-20

Study results available
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Summary

The purpose of this study is to assess the long-term persistence of immunity to hepatitis B in adolescents aged 15-16 years who were vaccinated with Engerixâ„¢-B Kinder in infancy. The study will also assess the immune response to a challenge dose of Engerixâ„¢-B Kinder in these subjects.

Conditions

Interventions

BIOLOGICAL

Engerixâ„¢-B Kinder

Single dose administered intramuscularly in the deltoid region of non-dominant arm at Day 0.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-19
Primary Completion
2014-02-21
Completion
2014-02-21

Countries

  • Germany

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01847430 on ClinicalTrials.gov