Trial | NCT00169858  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    1129
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).
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 Started
Sep 30
1995
Primary Completion
Oct 31
2011
Study Completion
May 31
2012
Last Update
May 29
2013
Estimate

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.

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
No Results Posted