Last updated: 11/07/2018 02:59:06

Long-term persistence of immunity against hepatitis B in 7-8 years old children after hepatitis B vaccination.

GSK study ID
110474
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: An open, phase IV, single-group, multicentre study to assess the long-term persistence of antibodies against hepatitis B and the immune response to a hepatitis B (HBV) vaccine challenge in children aged 7-8 years of age and previously vaccinated in infancy with GSK Biologicals’ HBV vaccine (Engerix™-B).
Trial description: The purpose of this study is to assess the persistence of immunity to hepatitis B in children who received three consecutive doses of HBV vaccine (EngerixTM-B) in infancy. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

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

Secondary outcomes:

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.

Interventions:
Biological/vaccine: Engerix™-B Kinder
Enrollment:
301
Observational study model:
Not applicable
Primary completion date:
2007-31-12
Time perspective:
Not applicable
Clinical publications:
Behre U et al. (2012) Long-term anti-HBs antibody persistence and immune memory in children and adolescents who received routine childhood hepatitis B vaccination. Hum Vaccin Immunother. 8(6):813-818.
Medical condition
Hepatitis B Vaccine
Product
SKF103860
Collaborators
Not applicable
Study date(s)
August 2007 to December 2007
Type
Interventional
Phase
4

Participation criteria

Sex
Female & Male
Age
7 - 8 years
Accepts healthy volunteers
Yes
  • 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.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Muenster, Nordrhein-Westfalen, Germany, 48163
Status
Study Complete
Location
GSK Investigational Site
Porta Westfalica, Nordrhein-Westfalen, Germany, 32457
Status
Study Complete
Location
GSK Investigational Site
Berlin, Berlin, Germany, 12679
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Offenburg, Baden-Wuerttemberg, Germany, 77654
Status
Study Complete
Location
GSK Investigational Site
Berlin, Berlin, Germany, 13055
Status
Study Complete
Location
GSK Investigational Site
Loehne, Nordrhein-Westfalen, Germany, 32584
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Trier, Rheinland-Pfalz, Germany, 54294
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bindlach, Bayern, Germany, 95463
Status
Study Complete
Location
GSK Investigational Site
Lohr, Bayern, Germany, 97816
Status
Study Complete
Location
GSK Investigational Site
Karlsruhe, Baden-Wuerttemberg, Germany, 76189
Status
Study Complete
Location
GSK Investigational Site
Minden, Nordrhein-Westfalen, Germany, 32427
Status
Study Complete
Location
GSK Investigational Site
Leipzig, Sachsen, Germany, 04103
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24937
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Husum, Schleswig-Holstein, Germany, 25813
Status
Study Complete
Location
GSK Investigational Site
Oberstenfeld, Baden-Wuerttemberg, Germany, 71720
Status
Study Complete
Location
GSK Investigational Site
Berlin, Berlin, Germany, 13507
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Pforzheim, Baden-Wuerttemberg, Germany, 75172
Status
Study Complete
Location
GSK Investigational Site
Muenchen, Bayern, Germany, 81241
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Birkenfeld, Baden-Wuerttemberg, Germany, 75217
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bredstedt, Schleswig-Holstein, Germany, 25821
Status
Study Complete
Location
GSK Investigational Site
Ettenheim, Baden-Wuerttemberg, Germany, 77955
Status
Study Complete
Location
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24943
Status
Study Complete
Location
GSK Investigational Site
Frankenthal, Rheinland-Pfalz, Germany, 67227
Status
Study Complete
Location
GSK Investigational Site
Kaufering, Bayern, Germany, 86916
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Tuttlingen, Baden-Wuerttemberg, Germany, 78532
Status
Study Complete
Location
GSK Investigational Site
Muenchen, Bayern, Germany, 81735
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24944
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Worms, Rheinland-Pfalz, Germany, 67547
Status
Study Complete
Location
GSK Investigational Site
Stuttgart, Baden-Wuerttemberg, Germany, 70469
Status
Study Complete
Location
GSK Investigational Site
Berlin, Berlin, Germany, 10967
Status
Study Complete
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Oberkirch, Baden-Wuerttemberg, Germany, 77704
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Tegernsee, Bayern, Germany, 83684
Status
Study Complete
Location
GSK Investigational Site
Kiel, Schleswig-Holstein, Germany, 24161
Status
Study Complete
Location
GSK Investigational Site
Heidelberg, Baden-Wuerttemberg, Germany, 69120
Status
Terminated/Withdrawn

Study documents

Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Completed
Actual primary completion date
2007-31-12
Actual study completion date
2007-31-12

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.

Additional information about the trial

Participate in clinical trial
Additional information
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Click here
Access to clinical trial data by researchers
Visit website