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Persistence of Immunity Against Hepatitis B in 12-13 Year Old Adolescents After Infant Hepatitis B Vaccination

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ClinicalTrials.gov Identifier: NCT00984139
Recruitment Status : Completed
First Posted : September 25, 2009
Results First Posted : March 1, 2011
Last Update Posted : November 3, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

September 24, 2009
September 25, 2009
February 3, 2011
March 1, 2011
November 3, 2016
October 2009
April 2010   (Final data collection date for primary outcome measure)
  • Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations as Measured by ELISA Equal to or Above Cut-off Value [ Time Frame: One month after the challenge dose (Month 1) ]
    The cut-off value was defined as 100 milli-international units per milliliter (mIU/mL).
  • Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations as Measured by ChemiLuminescence ImmunoAssay (CLIA) Equal to or Above Cut-off Value. [ Time Frame: One month after the challenge dose (Month 1) ]
    The cut-off value was defined as 100 milli-international units per milliliter (mIU/mL).
Anti-hepatitis B (Anti-HBs) antibody concentrations [ Time Frame: One month after the challenge dose of hepatitis B (HBV) vaccine ]
Complete list of historical versions of study NCT00984139 on ClinicalTrials.gov Archive Site
  • Number of Subjects With Anti-HBs Antibody Concentrations as Measured by ELISA Equal to or Above Cut-off Values [ Time Frame: Before (Day 0) and one month (Month 1) after the challenge dose ]

    The cut-off values were defined as 3.3 mIU/mL, 10 mIU/mL and 100 mIU/mL.

    Note: the number of subjects with anti-HBs antibody concentrations equal to or above 100 mIU/mL on month post-challenge dose data are presented as a primary outcome measure.

  • Number of Subjects With Anti-HBs Antibody Concentrations as Measured by CLIA Equal to or Above Cut-off Values [ Time Frame: Before (Day 0) and one month (Month 1) after the challenge dose ]
    The cut-off values were defined as 6.2 mIU/mL, 10 mIU/mL and 100 mIU/mL. Note: the number of subjects with anti-HBs antibody concentrations equal to or above 100 mIU/mL on month post-challenge dose data are presented as a primary outcome measure.
  • Number of Subjects With Solicited Local and General Symptoms [ Time Frame: During the 4-day (Day 0-3) follow-up period following the challenge dose vaccination ]

    Solicited local symptoms were pain, redness and swelling. Solicited general symptoms were fatigue, gastrointestinal symptoms, headache and fever.

    Fever was defined as axillary temperature greater than or equal to 37.5 degrees Celsius.

  • Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: After the challenge dose of the vaccine (Day 0) up to the study end (Month 1) ]
    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
  • Number of Subjects With Unsolicited Adverse Events (AEs) [ Time Frame: During the 31-day (Day 0-30) follow-up period following the challenge dose vaccination ]
    Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
  • Number of Subjects With Anamnestic Response to the Challenge Dose as Measured by ELISA. [ Time Frame: One month after the challenge dose (Month 1) ]
    Anamnestic response was defined as: - At least (i.e. greater than or equal to) a 4-fold rise in post-challenge vaccine dose anti-HBs antibody concentrations in subjects seropositive (i.e. with anti-HBs antibody concentration equal to or greater than 3.3 mIU/mL) at the pre-challenge dose time point. - Post-challenge dose anti-HBs antibody concentrations equal to or greater than 10 mIU/mL in subjects seronegative (i.e. with anti-HBs antibody concentrations less than 3.3 mIU/mL) at the pre-challenge dose time point.
  • Number of Subjects With Anamnestic Response to the Challenge Dose as Measured by CLIA. [ Time Frame: One month after the challenge dose (Month 1) ]
    Anamnestic response was defined as: - At least (i.e. greater than or equal to) a 4-fold rise in post-challenge vaccine dose anti-HBs antibody concentrations in subjects seropositive (i.e. with anti-HBs antibody concentration ≥ 6.2 mIU/mL) at the pre-challenge dose time point. - Post-challenge dose anti-HBs antibody concentrations equal to or greater than 10 mIU/mL in subjects seronegative (i.e. with anti-HBs antibody concentrations < 6.2 mIU/mL) at the pre-challenge dose time point.
  • Immune response to the study vaccine [ Time Frame: Before and one month after the challenge dose of HBV vaccine. ]
  • Solicited local and general symptoms [ Time Frame: During the 4-day (Day 0-3) follow-up period following the challenge dose vaccination ]
  • Unsolicited adverse events [ Time Frame: During the 31-day (Day 0-30) follow-up period following the challenge dose vaccination ]
  • Serious adverse events [ Time Frame: After the challenge dose of the vaccine up to the study end. ]
Not Provided
Not Provided
 
Persistence of Immunity Against Hepatitis B in 12-13 Year Old Adolescents After Infant Hepatitis B Vaccination
Long-term Persistence of Hepatitis B Antibodies and Immune Response to a Hepatitis B Vaccine Challenge in 12-13 Year Old Adolescents, Vaccinated in Infancy With GlaxoSmithKline (GSK) Biologicals' HBV Vaccine (Engerix™-B)
This phase IV open study will evaluate the persistence of humoral antibodies against hepatitis B as well as the immune response to a challenge dose of hepatitis B vaccine in adolescents aged 12-13 years, who received three consecutive doses of GSK Biologicals' recombinant hepatitis B vaccine (Engerix™-B) in infancy.
Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Hepatitis B
Biological: Engerix™-B Kinder
Intramuscular, one dose.
Other Names:
  • HBV vaccine
  • Engerix™-B
Experimental: Engerix-B Group
Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
Intervention: Biological: Engerix™-B Kinder
Behre U, Bleckmann G, Crasta PD, Leyssen M, Messier M, Jacquet JM, Hardt K. Long-term anti-HBs antibody persistence and immune memory in children and adolescents who received routine childhood hepatitis B vaccination. Hum Vaccin Immunother. 2012 Jun;8(6):813-8. doi: 10.4161/hv.19898. Epub 2012 Apr 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
306
300
April 2010
April 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects who the investigator believes that their parent(s)/Legally Accepted representative (LAR(s)) can and will comply with the requirements of the protocol.
  • A male or female of 12 to 13 years of age at the time of enrolment.
  • With documented evidence of previous vaccination with three consecutive doses of Engerix-B in Germany: with the first two doses received by 9 months of age and the third dose received by 18 months of age.
  • Written informed consent obtained from the parent(s) or LAR(s) of the subject at the time of enrolment.
  • Written informed assent obtained from the subject in addition to the informed consent signed by the parent(s)/LAR(s).
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Female subjects of non-childbearing potential may be enrolled in the study.
  • Females of childbearing potential at the time of study entry must have a negative pregnancy test prior to administration of the dose of vaccine and are required to be abstinent or to use adequate contraceptive precautions for one month prior to vaccination. Subjects are required to agree to continue such precautions for two months after vaccination.

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 third dose of Engerix-B vaccine.
  • History of hepatitis B disease.
  • Hepatitis B vaccination at birth.
  • Adolescents living in institutional care.
  • 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 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 (no laboratory testing required).
  • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the challenge dose of study vaccine, or planned use during the study period.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.
  • Known hypersensitivity to any component of the HBV vaccine or evidence of hypersensitivity after previous immunisation with a vaccine containing the hepatitis B component.
  • Acute disease and/or fever at the time of enrolment.
Sexes Eligible for Study: All
12 Years to 13 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00984139
112682
Not Provided
Not Provided
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP