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Hepatitis B Booster Study in Adolescence

NCT02169674 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 359

Last updated 2019-03-21

Study results available
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Summary

This study looks at protection in 10-11 and 15-16 year olds, immunized as infants with Hepatitis B (HB) vaccine to see if they still have residual protection against Hepatitis B disease. Adolescents will be invited to have a blood test and those without a minimal level of protection (antibody titer) will be offered a "test" vaccination to see if they still have capacity to recall an immune response. About one month later they will get another blood test to see if a booster response occurred. A few participants will have lost protection (no booster response) and will be offered a second HB vaccination to restore protection. Results of this study could influence the way in which children in British Columbia (BC) are immunized against HB disease.

Conditions

Interventions

BIOLOGICAL

EngerixB, GlaxoSmithKline Vaccines

Sponsors & Collaborators

  • Canadian Immunization Research Network

    collaborator NETWORK

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • University of British Columbia

    lead OTHER

Principal Investigators

  • David Scheifele, MD · University of British Columbia

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-08-31
Completion
2016-05-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT02169674 on ClinicalTrials.gov