Long-term persistence of immunity against hepatitis B in 7-8 years old children after hepatitis B vaccination.
Trial overview
Number of participants with anti-hepatitis B surface antigen (HBs) antibody concentrations above the cut-off value
Timeframe: One month after the challenge dose of HBV vaccine
Number of participants with Anti-HBs antibody concentrations above the cut-off value
Timeframe: Before challenge dose of HBV vaccine
Number of Participants reporting Solicited Local Symptoms
Timeframe: During the 4-day follow-up period after the challenge dose of HBV vaccine.
Number of Participants reporting Solicited General Symptoms
Timeframe: During the 4-day follow-up period after the challenge dose of HBV vaccine.
Number of Participants reporting Unsolicited adverse events
Timeframe: During the 31-day follow-up period after the challenge dose of HBV vaccine.
Number of Participants reporting serious adverse events (SAE)
Timeframe: After the challenge dose of HBV vaccine.
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
 - A male or female of 7 to 8 years of age (from and including the 7th birthday up to but excluding the 9th birthday) at the time of enrolment.
 
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product
 - Evidence of previous hepatitis B booster vaccination since administration of the third dose of Engerix™-B vaccine.
 
•Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol. •A male or female of 7 to 8 years of age (from and including the 7th birthday up to but excluding the 9th birthday) at the time of enrolment. •With documented evidence of previous vaccination with three consecutive doses of Engerix™-B in Germany •Written informed consent obtained from the parents or guardians of the subject at the time of enrolment. •Healthy subjects as established by medical history and clinical examination before entering into the study.
•Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product •Evidence of previous hepatitis B booster vaccination since administration of the third dose of Engerix™-B vaccine. •History of or intercurrent hepatitis B disease. •Hepatitis B vaccination at birth. •Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before HBV vaccine challenge and ending 30 days after. •Administration of immunoglobulins and/or any blood products within the three months preceding HBV vaccine challenge or planned administration during the study period. •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the HBV vaccine challenge. •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.