NCT00169858

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

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,129 (actual)
• Sponsor: Laval University · Academic / Other
• Sex: All
• Age: 8 Years – 10 Years
• Healthy volunteers: Accepted

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).

Detailed 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

Conditions

• Hepatitis B
• Vaccination

Interventions

Type	Name	Description
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.

Timeline

• Start date: 1995-09-01
• Primary completion: 2011-10-01
• Completion: 2012-05-01
• First posted: 2005-09-15
• Last updated: 2013-05-29

Locations

1 site across 1 country: Canada