Last updated: 11/07/2018 04:59:39
Hepatitis B antibody persistence and immune response to hepatitis B vaccine challenge in previously vaccinated children
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Long-term antibody persistence of hepatitis B antibodies and immune response to a hepatitis B vaccine (Engerix-B Kinder) challenge in children previously vaccinated with Infanrix hexa vaccine
Trial description: This study will evaluate the persistence of immunity to hepatitis B in healthy children aged 7 to 8 years, after previous vaccination with Infanrix hexa™ in the first two years of life, and also their ability to mount an immune response to the challenge dose of Engerix-B™ Kinder.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Number of subjects with anti-hepatitis B (anti-HBs) antibody concentration equal to or above (≥) 100 milli-International units per milliliter (mIU/mL)
Timeframe: One month (Month 1) after a challenge dose of Engerix-B Kinder vaccine
Secondary outcomes:
Anti-HBs antibody concentrations after previous vaccination with Infanrix hexa vaccine.
Timeframe: Before (Day 0) a challenge dose of Engerix-B Kinder vaccine
Number of subjects with anti-HBs antibody concentrations equal to or above the protocol specified cut-off values after previous vaccination with Infanrix hexa vaccine
Timeframe: Before (Day 0) a challenge dose of Engerix-B Kinder vaccine
Number of subjects with anti-HBs antibody concentrations equal to or above protocol specified cut-off values
Timeframe: One month (Month 1) after a challenge dose of Engerix-B Kinder vaccine
Anti-HBs antibody concentrations
Timeframe: One month (Month 1) after a challenge dose of Engerix-B Kinder vaccine
Number of subjects demonstrating an anamnestic response to the Engerix-B Kinder challenge dose
Timeframe: After Engerix-B Kinder challenge dose (Month 1)
Number of subjects reporting any and grade 3 solicited local Adverse Events (AEs)
Timeframe: During the 4-day (Day 0-3) follow-up period after the challenge dose of Engerix-B Kinder vaccine
Number of subjects reporting any, grade 3 and related solicited general AEs
Timeframe: During the 4-day (Day 0-3) follow-up period after the challenge dose of Engerix-B Kinder vaccine
Number of subjects reporting any unsolicited AEs
Timeframe: During the 31-day (Day 0-30) follow-up period after the challenge dose of Engerix-B Kinder vaccine
Number of subjects reporting any serious adverse events (SAEs)
Timeframe: After the challenge dose of Engerix-B Kinder vaccine up to the study end (Day 0 to Month 1)
Interventions:
Enrollment:
300
Primary completion date:
2011-28-09
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Van der Meeren O et al. (2014) Immune memory to hepatitis B persists in children aged 7-8 years, who were vaccinated in infancy with four doses of hexavalent DTPa-HBV-IPV/Hib (Infanrix™ hexa) vaccine. Hum Vaccin Immunother. 10(6):1682-1687.
Medical condition
Hepatitis B
Product
SB217744, SKF103860
Collaborators
Not applicable
Study date(s)
April 2011 to September 2011
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
7 - 8 years
Accepts healthy volunteers
Yes
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
- A male or female 7 to 8 years of age at the time of enrolment.
- Child in care
- Use of any investigational or non-registered product, other than the study vaccine, within 30 days preceding the dose of study vaccine, or planned use during the study period.
Inclusion and exclusion criteria
Inclusion criteria:
- A male or female 7 to 8 years of age at the time of enrolment.
- Subjects with documented evidence of previous vaccination with four consecutive doses of Infanrix hexa™ as part of routine vaccination in Germany: three doses of primary vaccination received by 9 months of age and one booster dose received between 11 and 18 months of age.
- Written informed consent obtained from the parents/Legally Acceptable Representative(s) of the subject at the time of enrolment.
- In addition to the informed consent that will be signed by the parent(s)/Legally Acceptable Representative(s), written informed assent of the subject will be sought when the subject is judged able to understand by the investigator.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
Exclusion criteria:
- Use of any investigational or non-registered product, other than the study vaccine, within 30 days preceding the dose of study vaccine, or planned use during the study period.
- 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 and ending 30 days after the hepatitis B vaccine challenge dose.
- Administration of immunoglobulins and/or any blood products within the three months preceding challenge dose or planned administration during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the challenge dose of HBV vaccine.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the hepatitis B vaccine, or evidence of hypersensitivity after previous immunisation with a vaccine containing the hepatitis B component.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Acute disease and/or fever at the time of enrolment.
Child in care
Trial location(s)
Location
GSK Investigational Site
Kehl, Baden-Wuerttemberg, Germany, 77694
Status
Study Complete
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
Bad Saulgau, Baden-Wuerttemberg, Germany, 88348
Status
Study Complete
Location
GSK Investigational Site
Muenster, Nordrhein-Westfalen, Germany, 48163
Status
Study Complete
Showing 1 - 6 of 12 Results
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
Study complete
Actual primary completion date
2011-28-09
Actual study completion date
2011-28-09
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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