Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:11 AM
Ignite Modification Date:
2025-12-25 @ 12:11 AM
NCT ID:
NCT00169858
Eligibility 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
10 Years
Study:
NCT00169858
Study Brief:
Protocol Section:
NCT00169858