Last updated: 11/03/2018 09:11:14
Persistence of hepatitis B antibody levels & immune response to a hepatitis B vaccine challenge
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Assess long-term persistence of hepatitis B antibodies & immune response to a hepatitis B vaccine (Engerix-B Kinder) challenge in children aged 4-5 years (previously primed & boosted in the 1st 2 years of life with DTPa-HBV-IPV/Hib vaccine)
Trial description: The purpose of this study is to determine at 5 years of age the persistence of immunity to hepatitis B that was conferred by infant vaccination with Infanrix hexa™.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:
Anti-hepatitis B surface antigen (HBs) antibody concentrations
Timeframe: One month after the challenge dose of HBV vaccine
Secondary outcomes:
Anti-HBs antibody concentrations
Timeframe: Before and after challenge dose of HBV vaccine
Occurrence of serious adverse events
Timeframe: During the entire study period.
Interventions:
Biological/vaccine: Engerix™-B Kinder
Enrollment:
301
Observational study model:
Not applicable
Primary completion date:
2007-14-05
Time perspective:
Not applicable
Clinical publications:
Steiner M et al. (2010) Lasting immune memory against hepatitis B in children after primary immunization with 4 doses of DTPa-HBV-IPV/Hib in the first and 2nd year of life. BMC Inf Dis. 10(9): 1-5.
Steiner M et al. (2010) Lasting immune memory against hepatitis B in children after primary immunization with 4 doses of DTPa-HBV-IPV/Hib in the first and 2nd year of life. BMC Inf Dis.10(9): 1-5.
Medical condition
Hepatitis B
Product
SB217744
Collaborators
Not applicable
Study date(s)
December 2006 to May 2007
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
4 - 5 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 4 to 5 years of age 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 fourth dose of Infanrix hexa™ booster in the second year of life.
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol
- A male or female of 4 to 5 years of age at the time of enrolment.
- With documented evidence of previous vaccination with four consecutive doses of Infanrix hexa™ 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.
Exclusion criteria:
- 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 fourth dose of Infanrix hexa™ booster in the second year of life.
- 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 booster vaccination and ending 30 days after.
- Administration of immunoglobulins and/or any blood products within the three months preceding booster vaccination 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.
Trial location(s)
Location
GSK Investigational Site
Gau-Odernheim, Rheinland-Pfalz, Germany, 55239
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Schoeneberg - Kuebelberg, Rheinland-Pfalz, Germany, 66901
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bad Saulgau, Baden-Wuerttemberg, Germany, 88348
Status
Study Complete
Location
GSK Investigational Site
Pforzheim, Baden-Wuerttemberg, Germany, 75172
Status
Study Complete
Location
GSK Investigational Site
Oberstenfeld, Baden-Wuerttemberg, Germany, 71720
Status
Study Complete
Location
GSK Investigational Site
Dudenhofen, Rheinland-Pfalz, Germany, 67373
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Tuttlingen, Baden-Wuerttemberg, Germany, 78532
Status
Study Complete
Location
GSK Investigational Site
Kirchzarten, Baden-Wuerttemberg, Germany, 79199
Status
Study Complete
Location
GSK Investigational Site
Herbolzheim, Baden-Wuerttemberg, Germany, 79336
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Stuttgart, Baden-Wuerttemberg, Germany, 70469
Status
Study Complete
Location
GSK Investigational Site
Frankenthal, Rheinland-Pfalz, Germany, 67227
Status
Study Complete
Location
GSK Investigational Site
Ehingen, Baden-Wuerttemberg, Germany, 89584
Status
Study Complete
Location
GSK Investigational Site
Kehl, Baden-Wuerttemberg, Germany, 77694
Status
Study Complete
Location
GSK Investigational Site
Gerolstein, Rheinland-Pfalz, Germany, 54568
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Noerdlingen, Bayern, Germany, 86720
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Aschaffenburg, Bayern, Germany, 63739
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Trier, Rheinland-Pfalz, Germany, 54294
Status
Study Complete
Location
GSK Investigational Site
Offenburg, Baden-Wuerttemberg, Germany, 77654
Status
Study Complete
Location
GSK Investigational Site
Ettenheim, Baden-Wuerttemberg, Germany, 77955
Status
Study Complete
Location
GSK Investigational Site
Tettnang, Baden-Wuerttemberg, Germany, 88069
Status
Study Complete
Location
GSK Investigational Site
Trier, Rheinland-Pfalz, Germany, 54290
Status
Study Complete
Location
GSK Investigational Site
Boennigheim, Baden-Wuerttemberg, Germany, 74357
Status
Study Complete
Location
GSK Investigational Site
Bietigheim/Bissingen, Baden-Wuerttemberg, Germany, 74321
Status
Study Complete
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
Refer to study documents
Recruitment status
Completed
Actual primary completion date
2007-14-05
Actual study completion date
2007-14-05
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.
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