search
Back to results

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

Primary Purpose

Hepatitis B

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Engerix™-B Kinder
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatitis B focused on measuring persistence, HBV, Long-term, Engerix™-B Kinder, Hepatitis B, adolescent

Eligibility Criteria

12 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Engerix-B Group

Arm Description

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).

Outcomes

Primary Outcome Measures

Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations as Measured by ELISA Equal to or Above Cut-off Value
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.
The cut-off value was defined as 100 milli-international units per milliliter (mIU/mL).

Secondary Outcome Measures

Number of Subjects With Anti-HBs Antibody Concentrations as Measured by ELISA Equal to or Above Cut-off Values
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
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
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 Unsolicited Adverse Events (AEs)
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 Serious Adverse Events (SAEs)
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 Anamnestic Response to the Challenge Dose as Measured by ELISA.
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.
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.

Full Information

First Posted
September 24, 2009
Last Updated
July 2, 2018
Sponsor
GlaxoSmithKline
search

1. Study Identification

Unique Protocol Identification Number
NCT00984139
Brief Title
Persistence of Immunity Against Hepatitis B in 12-13 Year Old Adolescents After Infant Hepatitis B Vaccination
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
October 12, 2009 (undefined)
Primary Completion Date
April 7, 2010 (Actual)
Study Completion Date
April 7, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B
Keywords
persistence, HBV, Long-term, Engerix™-B Kinder, Hepatitis B, adolescent

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
306 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Engerix-B Group
Arm Type
Experimental
Arm Description
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 Type
Biological
Intervention Name(s)
Engerix™-B Kinder
Other Intervention Name(s)
HBV vaccine, Engerix™-B
Intervention Description
Intramuscular, one dose.
Primary Outcome Measure Information:
Title
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations as Measured by ELISA Equal to or Above Cut-off Value
Description
The cut-off value was defined as 100 milli-international units per milliliter (mIU/mL).
Time Frame
One month after the challenge dose (Month 1)
Title
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.
Description
The cut-off value was defined as 100 milli-international units per milliliter (mIU/mL).
Time Frame
One month after the challenge dose (Month 1)
Secondary Outcome Measure Information:
Title
Number of Subjects With Anti-HBs Antibody Concentrations as Measured by ELISA Equal to or Above Cut-off Values
Description
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.
Time Frame
Before (Day 0) and one month (Month 1) after the challenge dose
Title
Number of Subjects With Anti-HBs Antibody Concentrations as Measured by CLIA Equal to or Above Cut-off Values
Description
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.
Time Frame
Before (Day 0) and one month (Month 1) after the challenge dose
Title
Number of Subjects With Solicited Local and General Symptoms
Description
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.
Time Frame
During the 4-day (Day 0-3) follow-up period following the challenge dose vaccination
Title
Number of Subjects With Unsolicited Adverse Events (AEs)
Description
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.
Time Frame
During the 31-day (Day 0-30) follow-up period following the challenge dose vaccination
Title
Number of Subjects With Serious Adverse Events (SAEs)
Description
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.
Time Frame
After the challenge dose of the vaccine (Day 0) up to the study end (Month 1)
Title
Number of Subjects With Anamnestic Response to the Challenge Dose as Measured by ELISA.
Description
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.
Time Frame
One month after the challenge dose (Month 1)
Title
Number of Subjects With Anamnestic Response to the Challenge Dose as Measured by CLIA.
Description
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.
Time Frame
One month after the challenge dose (Month 1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Ettenheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
77955
Country
Germany
Facility Name
GSK Investigational Site
City
Kehl
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
77694
Country
Germany
Facility Name
GSK Investigational Site
City
Mannheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
68163
Country
Germany
Facility Name
GSK Investigational Site
City
Pforzheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
75172
Country
Germany
Facility Name
GSK Investigational Site
City
Schwaebisch-Hall
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
74523
Country
Germany
Facility Name
GSK Investigational Site
City
Stuttgart
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
70469
Country
Germany
Facility Name
GSK Investigational Site
City
Tuttlingen
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
78532
Country
Germany
Facility Name
GSK Investigational Site
City
Bindlach
State/Province
Bayern
ZIP/Postal Code
95463
Country
Germany
Facility Name
GSK Investigational Site
City
Cham
State/Province
Bayern
ZIP/Postal Code
93413
Country
Germany
Facility Name
GSK Investigational Site
City
Gilching
State/Province
Bayern
ZIP/Postal Code
82205
Country
Germany
Facility Name
GSK Investigational Site
City
Kempten
State/Province
Bayern
ZIP/Postal Code
87435
Country
Germany
Facility Name
GSK Investigational Site
City
Kirchheim
State/Province
Bayern
ZIP/Postal Code
85551
Country
Germany
Facility Name
GSK Investigational Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81375
Country
Germany
Facility Name
GSK Investigational Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81735
Country
Germany
Facility Name
GSK Investigational Site
City
Noerdlingen
State/Province
Bayern
ZIP/Postal Code
86720
Country
Germany
Facility Name
GSK Investigational Site
City
Braunatal
State/Province
Hessen
ZIP/Postal Code
34225
Country
Germany
Facility Name
GSK Investigational Site
City
Duisburg
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
47137
Country
Germany
Facility Name
GSK Investigational Site
City
Muenster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48163
Country
Germany
Facility Name
GSK Investigational Site
City
Frankenthal
State/Province
Rheinland-Pfalz
ZIP/Postal Code
67227
Country
Germany
Facility Name
GSK Investigational Site
City
Worms
State/Province
Rheinland-Pfalz
ZIP/Postal Code
67547
Country
Germany
Facility Name
GSK Investigational Site
City
Weimar
State/Province
Thueringen
ZIP/Postal Code
99425
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10315
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10967
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13055
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
22508412
Citation
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.
Results Reference
derived
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112682
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112682
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112682
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112682
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112682
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112682
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112682
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

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

We'll reach out to this number within 24 hrs