Long Term Immunogenicity Study of Engerix-B Vaccine in 10 Year Old Children and the Effect of Booster Injections
Information source: Laval University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis B; Vaccination
Intervention: Engerix-B (Biological)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Laval University Official(s) and/or principal investigator(s):
Bernard Duval, MD, Principal Investigator, Affiliation: Laval University Hospital Center, Public Health Research Unit
Summary
Hepatitis B immunization is offered to all grade 4 students (age9-10) 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 Details
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
Study design: Prevention, Randomized, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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 outcome: - 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
Detailed description:
Three doses of Engerix-B vaccine (10 mkg) were administered (0, 1, 6 month schedule) to 1200
ten 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
Eligibility
Minimum age: 8 Years.
Maximum age: 10 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Previously completed the 1995 to 1996 Hepatitis B vaccination program vaccinations
(Primary study) to the best of his/her knowledge and already enrolled and followed in
the long term study
- Must be HBc negative
- Required standard interval between last dose of primary immunization and booster
vaccination
- Written informed consent obtained from the subject
- Free of obvious health problems as established by medical history and clinical
examination before entering into the study
- Previously completed routine childhood vaccination to the best of his/her knowledge
- If the subject is female, and the potential of pregnancy exists, it must be asked
prior to immunization by the study nurse. According to the protocol d'immunisation du
Québec, Engerix-B is not contra-indicated during pregnancy. However, if a participant
thinks she could be pregnant (sexually active and no oral contraception or intra
uterine device), a pregnancy test will be carried out. In case of pregnancy, the
booster vaccination will be performed after delivery.
Exclusion Criteria:
- Not applicable
Locations and Contacts
Research Center of Laval University Hospital Center, Public Health Research Unit, Quebec G1E 7G9, Canada
Additional Information
Starting date: September 1995
Ending date: September 2010
Last updated: November 18, 2005
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