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 @ 5:19 AM
Ignite Modification Date:
2025-12-25 @ 5:19 AM
NCT ID:
NCT00383227
Eligibility Criteria:
Inclusion Criteria:
* A male or female \> = 15 years of age at the time of the first vaccination.
* Written informed consent obtained from the subject/ from the parents or guardians of the subject.
* Seronegative for anti-HBs antibodies, anti-HBc antibodies \& Hepatitis B Surface antigen (HBsAg).
* If the subject was a female, she was of non-childbearing potential or, if of childbearing potential, she had to be abstinent or use adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination.
* Pre-haemodialysis patient\* or a patient on haemodialysis.
Exclusion Criteria:
* Use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period or within 30 days preceding the first dose of study vaccine.
* Previous vaccination against hepatitis B.
* History of hepatitis B infection.
* Known exposure to hepatitis B virus within 6 weeks. Pregnant or lactating female
* Clinically abnormal ALT/AST values (\> 3 times normal values)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Study:
NCT00383227
Study Brief:
Protocol Section:
NCT00383227