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Long Term Immunogenicity Study of Engerix-B Vaccine in 10 Year Old Children and the Effect of Booster Injections

NCT00169858 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1129

Last updated 2013-05-29

No results posted yet for this study

Summary

Hepatitis B immunization has been offered to all grade 4 students (age 9-10) in the province of Quebec, using Engerix-B at a dose of 10 mkg. The peak incidence of hepatitis B occurs between age 15 and 35; the proportion of vaccinated children who will still be protected at this age is currently unknown. This study is designed to determine:

* persistence of immunity until age 25
* persistence of immunological memory as demonstrated by an anamnestic response following a booster dose
* the effect of a booster dose on immunogenicity at either 5, 10 or 15 years after the primary vaccination course (at age (15, 20 or 25).

Conditions

Interventions

BIOLOGICAL

Engerix-B

10 mkg per dose; 3 doses according to 0, 1, 6 month schedule; booster doses 5, 10 or 15 years post-primary vaccination.

Sponsors & Collaborators

  • Institut National en Santé Publique du Québec

    collaborator OTHER

  • Centre de Recheche du Centre Hospitalier Université Laval

    collaborator OTHER

  • SmithKlinBeecham Biologicals

    collaborator UNKNOWN

  • Laval University

    lead OTHER

Principal Investigators

  • Bernard Duval, MD · Laval University Hospital Center, Public Health Research Unit

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
1995-09-30
Primary Completion
2011-10-31
Completion
2012-05-31

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 NCT00169858 on ClinicalTrials.gov