Status:
COMPLETED
Long Term Immunogenicity Study of Engerix-B Vaccine in 10 Year Old Children and the Effect of Booster Injections
Lead Sponsor:
Laval University
Collaborating Sponsors:
Institut National en Santé Publique du Québec
Centre de Recheche du Centre Hospitalier Université Laval
Conditions:
Hepatitis B
Vaccination
Eligibility:
All Genders
8-10 years
Phase:
PHASE4
Brief 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...
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 an...
Eligibility Criteria
Inclusion
- 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
- \- Not applicable
Key Trial Info
Start Date :
September 1 1995
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
1129 Patients enrolled
Trial Details
Trial ID
NCT00169858
Start Date
September 1 1995
End Date
May 1 2012
Last Update
May 29 2013
Active Locations (1)
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1
Vladimir Gilca
Québec, Quebec, Canada, G1E 7G9