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This study will evaluate the persistence of immunity to hepatitis B 10 to 11 years after vaccination with Infanrix hexa™ or Engerix™-B and also the ability to mount an immune response to the challenge dose of Engerix™-B.
Subjects who participated in the primary study 217744/031 (NCT01457495) will be invited at the age of 11-12 years to participate in this follow-up study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infanrix-hexa/Engerix-B Group | Experimental | Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (217744/031 (NCT01457495)) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm. |
|
| Infanrix-IPV+Hib/Engerix-B Group | Active Comparator | Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (217744/031 (NCT01457495)) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Engerix™-B | Biological | Intramuscular, single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 100 Milli-International Units Per Milliliter (mIU/mL) | A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis. | One month after a challenge dose of Engerix-B vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With an Anamnestic Response to a Challenge Dose | The anamnestic response was defined as: at least (≥) a 4-fold rise in post-challenge dose anti-HBs antibody concentrations in subjects seropositive at the pre-challenge dose time point. - Post-challenge dose anti-HBs antibody concentrations ≥ 10 mIU/mL in seronegative subjects at the pre-challenge dose time point. A seropositive/seronegative subject is a subject with anti-HBs antibody concentration ≥/lower than (<) 6.2 mIU/mL. A decrease in the specificity of the anti-HB ELISA had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis and the initial 3.3 mIU/mL seropositivity cut-off was revised into the new 6.2 mIU/mL cut-off. |
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Inclusion Criteria:
Subjects who the investigator believes that their parents/Legally acceptable representative) can and will comply with the requirements of the protocol should be enrolled in the study.
A male or female aged 11-12 years at the time of study entry (from and including the 11th birthday until and excluding the 13th birthday).
Written informed consent obtained from the parent or Legally Acceptable Representative of the subject.
Study procedures will be explained to subjects and depending on their understanding, optional informed assent will be sought at the discretion of the investigator.
Written informed assent obtained from the subject in addition to the informed consent signed by the parent(s)/ Legally Acceptable Representative (s).
Healthy subjects as established by medical history and clinical examination before entering into the study.
Subjects who have received all three doses of Infanrix hexa or Engerix-B in the primary study 217744/031 (NCT01457495).
Female subjects of non-childbearing potential may be enrolled in the study.
Female subjects of childbearing potential may be enrolled in the study, if the subject:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Banská Bystrica | 974 01 | Slovakia | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24962750 | Derived | Avdicova M, Crasta PD, Hardt K, Kovac M. Lasting immune memory against hepatitis B following challenge 10-11 years after primary vaccination with either three doses of hexavalent DTPa-HBV-IPV/Hib or monovalent hepatitis B vaccine at 3, 5 and 11-12 months of age. Vaccine. 2015 May 28;33(23):2727-33. doi: 10.1016/j.vaccine.2014.06.070. Epub 2014 Jun 22. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 113954 | Clinical Study Report | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Infanrix-hexa/Engerix-B Group | Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Before and one month after a challenge dose of Engerix-B vaccine |
| Number of Subjects With Anti-HBs Antibody Concentration ≥ 6.2 mIU/mL | A seropositive subject was defined as a subject with anti-HBs antibody concentration ≥ the 6.2 mIU/mLcut-off. A decrease in the specificity of the anti-HB ELISA had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis and the initial 3.3 mIU/mL seropositivity cut-off was revised into the new 6.2 mIU/mL cut-off. | Before and one month after a challenge dose of Engerix-B vaccine |
| Number of Subjects With Anti-HBs Antibody Concentration ≥ 10 mIU/mL | A seroprotected subject was defined as a subject with anti-HBs antibody concentration ≥ 10 mIU/mL. A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis. | Before and one month after a challenge dose of Engerix-B vaccine |
| Number of Subjects With Anti-HBs Antibody Concentration ≥ 100 mIU/mL | A seroprotected subject was defined as a subject with anti-HBs antibody concentration ≥ 10 mIU/mL. A decrease in the specificity of the anti-HB ELISA had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis. | Before the challenge dose of Engerix-B vaccine |
| Number of Subjects Reporting Solicited Local Symptoms | Solicited local symptoms assessed were pain, redness and swelling. | During the 4-day (Days 0-3) follow-up period after a challenge dose of Engerix-B vaccine |
| Number of Subjects Reporting Solicited General Symptoms | Solicited general symptoms assessed were fatigue, gastrointestinal, headache and temperature (Temperature is defined as axillary temparature equal to or above 37.5 degrees Celsius (°C)). | During the 4-day (Days 0-3) follow-up period after a challenge dose of Engerix-B vaccine |
| Number of Subjects Reporting Unsolicited Adverse Events (AEs) | An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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. | During the 31-day (Days 0-30) follow-up period after a challenge dose of Engerix-B vaccine |
| Number of Subjects Reporting Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. | After the challenge dose of Engerix-B vaccine up to the study end |
| Dolný Kubín |
| 026 01 |
| Slovakia |
| GSK Investigational Site | Dubnica nad Váhom | 018 41 | Slovakia |
| GSK Investigational Site | Martin | 036 01 | Slovakia |
| GSK Investigational Site | Nitra | 949 01 | Slovakia |
| GSK Investigational Site | Nová Dubnica | 018 51 | Slovakia |
| GSK Investigational Site | Nové Zámky | 940 01 | Slovakia |
| GSK Investigational Site | Púchov | 020 01 | Slovakia |
| GSK Investigational Site | Rožňava | 048 01 | Slovakia |
| GSK Investigational Site | Trebišov | 075 01 | Slovakia |
| GSK Investigational Site | Zlaté Moravce | 953 01 | Slovakia |
For additional information about this study please refer to the GSK Clinical Study Register |
| 113954 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113954 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113954 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113954 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113954 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Infanrix-IPV+Hib/Engerix-B Group |
Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Infanrix-hexa/Engerix-B Group | Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm. |
| BG001 | Infanrix-IPV+Hib/Engerix-B Group | Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 100 Milli-International Units Per Milliliter (mIU/mL) | A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis. | The According-To-Protocol (ATP) cohort for analysis of immunogenicity included all evaluable subjects (i.e. those meeting eligibility criteria, complied with the procedures, with no elimination criteria) who had received a challenge dose Engerix-B vaccine and for whom immunogenicity data were available at the post-Engerix-B challenge time-point. | Posted | Count of Participants | Participants | One month after a challenge dose of Engerix-B vaccine |
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| Secondary | Number of Subjects With an Anamnestic Response to a Challenge Dose | The anamnestic response was defined as: at least (≥) a 4-fold rise in post-challenge dose anti-HBs antibody concentrations in subjects seropositive at the pre-challenge dose time point. - Post-challenge dose anti-HBs antibody concentrations ≥ 10 mIU/mL in seronegative subjects at the pre-challenge dose time point. A seropositive/seronegative subject is a subject with anti-HBs antibody concentration ≥/lower than (<) 6.2 mIU/mL. A decrease in the specificity of the anti-HB ELISA had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis and the initial 3.3 mIU/mL seropositivity cut-off was revised into the new 6.2 mIU/mL cut-off. | The According-To-Protocol (ATP) cohort for analysis of immunogenicity included all evaluable subjects (i.e. those meeting eligibility criteria, complied with the procedures, with no elimination criteria) who had received a challenge dose Engerix-B vaccine and for whom immunogenicity data were available at the post-Engerix-B challenge time-point. | Posted | Count of Participants | Participants | Before and one month after a challenge dose of Engerix-B vaccine |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Anti-HBs Antibody Concentration ≥ 6.2 mIU/mL | A seropositive subject was defined as a subject with anti-HBs antibody concentration ≥ the 6.2 mIU/mLcut-off. A decrease in the specificity of the anti-HB ELISA had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis and the initial 3.3 mIU/mL seropositivity cut-off was revised into the new 6.2 mIU/mL cut-off. | The According-To-Protocol (ATP) cohort for analysis of immunogenicity included all evaluable subjects (i.e. those meeting eligibility criteria, complied with the procedures, with no elimination criteria) who had received a challenge dose Engerix-B vaccine and for whom immunogenicity data were available at the post-Engerix-B challenge time-point. | Posted | Count of Participants | Participants | Before and one month after a challenge dose of Engerix-B vaccine |
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| Secondary | Number of Subjects With Anti-HBs Antibody Concentration ≥ 10 mIU/mL | A seroprotected subject was defined as a subject with anti-HBs antibody concentration ≥ 10 mIU/mL. A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis. | The According-To-Protocol (ATP) cohort for analysis of immunogenicity included all evaluable subjects (i.e. those meeting eligibility criteria, complied with the procedures, with no elimination criteria) who had received a challenge dose Engerix-B vaccine and for whom immunogenicity data were available at the post-Engerix-B challenge time-point. | Posted | Count of Participants | Participants | Before and one month after a challenge dose of Engerix-B vaccine |
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| Secondary | Number of Subjects With Anti-HBs Antibody Concentration ≥ 100 mIU/mL | A seroprotected subject was defined as a subject with anti-HBs antibody concentration ≥ 10 mIU/mL. A decrease in the specificity of the anti-HB ELISA had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis. | The According-To-Protocol (ATP) cohort for analysis of immunogenicity included all evaluable subjects (i.e. those meeting eligibility criteria, complied with the procedures, with no elimination criteria) who had received a challenge dose Engerix-B vaccine and for whom immunogenicity data were available at the post-Engerix-B challenge time-point. | Posted | Count of Participants | Participants | Before the challenge dose of Engerix-B vaccine |
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| Secondary | Number of Subjects Reporting Solicited Local Symptoms | Solicited local symptoms assessed were pain, redness and swelling. | The Total Vaccinated cohort included all subjects who received the challenge dose of Engerix-B vaccine. | Posted | Count of Participants | Participants | During the 4-day (Days 0-3) follow-up period after a challenge dose of Engerix-B vaccine |
|
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| Secondary | Number of Subjects Reporting Solicited General Symptoms | Solicited general symptoms assessed were fatigue, gastrointestinal, headache and temperature (Temperature is defined as axillary temparature equal to or above 37.5 degrees Celsius (°C)). | The Total Vaccinated cohort included all subjects who received the challenge dose of Engerix-B vaccine. | Posted | Count of Participants | Participants | During the 4-day (Days 0-3) follow-up period after a challenge dose of Engerix-B vaccine |
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| Secondary | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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. | The Total Vaccinated cohort included all subjects who received the challenge dose of Engerix-B vaccine. | Posted | Count of Participants | Participants | During the 31-day (Days 0-30) follow-up period after a challenge dose of Engerix-B vaccine |
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| Secondary | Number of Subjects Reporting Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. | The Total Vaccinated cohort included all subjects who received the challenge dose of Engerix-B vaccine. | Posted | Count of Participants | Participants | After the challenge dose of Engerix-B vaccine up to the study end |
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Solicited symptoms: During the 4-day (Days 0-3) follow-up period after the challenge dose of Engerix-B vaccine. SAEs: after the challenge dose of Engerix-B vaccine up to the study end
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Infanrix-hexa/Engerix-B Group | Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm. | 0 | 95 | 1 | 95 | 48 | 95 |
| EG001 | Infanrix-IPV+Hib/Engerix-B Group | Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm. | 0 | 90 | 0 | 90 | 43 | 90 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Redness | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Swelling | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Gastrointestinal | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Headache | General disorders | MedDRA 14.0 | Systematic Assessment |
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GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| OG001 | Infanrix-IPV+Hib/Engerix-B Group | Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm. |
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Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
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