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

Hepatitis B Clinical Trial

Official title: Open Randomised Clinical Study of the Long Term Immunogenicity of Engerix-B in 10 Year Old Children and of the Effect of Booster Injections Given 5, 10 or 15 Years After Primary Vaccination

Status Completed

Clinical Trial 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).

Clinical Trial Description

Three doses of Engerix-B vaccine (10 mkg) were administered according to 0, 1, 6 month schedule to 1126 9-10 year-old children.

The primary objective of the study is to evaluate the persistence of antibodies to Engerix-B in all subjects at age 25 and to compare the levels obtained in those given a booster injection at age 15 or 20 with those receiving no booster injection.

Secondary objectives

• To determine the antibody levels obtained following primary vaccination and the proportion of children who seroconvert

• To determine the antibody levels of one third of subjects at age 15, 5 years after primary vaccination (Group A)

• To determine the effect on antibody levels of a booster injection at age 15 years given to one third of the subjects (Group A)

• To determine the antibody levels of subjects in groups A and B at age 20, 5 years after booster (Group A), 10 years after primary vaccination (Group B)

• To determine the effect on antibody levels of a booster injection at age 20 years given to one third of the subjects (Group B)

• To determine the effect on antibody levels of a booster injection at age 25 years given to one third of the subjects (Group C)

• To determine the antibody levels of subjects in Group A and Group B one year after their 5 or 10 year booster

• To evaluate safety ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis B
• Vaccination

• NCT number: NCT00169858
• Study type: Interventional
• Source: Laval University
• Status: Completed
• Phase: Phase 4
• Start date: September 1995
• Completion date: May 2012