Hepatitis B
Conditions
Keywords
immune response, Engerix-B™Kinder, Persistence, challenge dose
Brief summary
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.
Interventions
BIOLOGICALEngerix-B™ Kinder
Intramuscular, single dose
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 8 Years
Healthy volunteers
Yes
Inclusion criteria
* 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. * 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.
Exclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 100 Milli-International Units Per Milliliter (mIU/mL) | One month (Month 1) after a challenge dose of Engerix-B Kinder vaccine | A decrease in the specificity of the anti-HBs enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of anti-HBs antibodies (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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Before (Day 0) a challenge dose of Engerix-B Kinder vaccine | Anti-HBs antibody concentrations cut-off values assessed were ≥ 6.2 mIU/mL (previously 3.3 mIU/mL), ≥ 10 mIU/mL, ≥ 10 mIU/mL to \<100 mIU/mL and ≥ 100 mIU/mL. A decrease in the specificity of the anti-HBs ELISA had been observed in some studies for low levels of anti-HBs antibodies (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. |
| Number of Subjects With Anti-HBs Antibody Concentrations Equal to or Above Protocol Specified Cut-off Values | One month (Month 1) after a challenge dose of Engerix-B Kinder vaccine | Anti-HBs antibody concentrations cut-off values assessed were ≥ 6.2 mIU/mL (previously 3.3 mIU/mL) and ≥ 10 mIU/mL. A decrease in the specificity of the anti-HBs ELISA had been observed in some studies for low levels of anti-HBs antibodies (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. |
| Anti-HBs Antibody Concentrations | One month (Month 1) after a challenge dose of Engerix-B Kinder vaccine | Antibody concentrations are expressed as Geometric mean antibody concentrations (GMCs) in mIU/mL. A decrease in the specificity of the anti-HBs 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. |
| Number of Subjects Demonstrating an Anamnestic Response to the Engerix-B Kinder Challenge Dose | After Engerix-B Kinder challenge dose (Month 1) | The anamnestic response is defined as an antibody concentration ≥ 10 mIU/mL at post Engerix-B Kinder challenge dose time point for initially seronegative subjects ,and as an antibody concentration at post Engerix-B Kinder challenge dose time point ≥ 4 fold the pre-vaccination antibody concentration for initially seropositive subjects. A seropositive/seronegative subject was defined as subject with HBs antibody concentration below/greater than or equal to the seropositivity cut-off of 6.2 mIU/mL. A decrease in the specificity of the anti-HBs 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. |
| Anti-HBs Antibody Concentrations After Previous Vaccination With Infanrix Hexa Vaccine. | Before (Day 0) a challenge dose of Engerix-B Kinder vaccine | Antibody concentrations are expressed as Geometric mean antibody concentrations (GMCs) in mIU/mL. A decrease in the specificity of the anti-HBs ELISA had been observed in some studies for low levels of anti-HBs antibodies (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. |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | During the 4-day (Day 0-3) follow-up period after the challenge dose of Engerix-B Kinder vaccine | Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and temeperature. Any temperature was defined as axillary temperature ≥ 37.5 degree centigrade (°C), grade 3 temperature was axillary temperature \> 39.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects Reporting Any Unsolicited AEs | During the 31-day (Day 0-30) follow-up period after the challenge dose of Engerix-B Kinder vaccine | 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. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. |
| Number of Subjects Reporting Any Serious Adverse Events (SAEs) | After the challenge dose of Engerix-B Kinder vaccine up to the study end (Day 0 to 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. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination. |
| Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | During the 4-day (Day 0-3) follow-up period after the challenge dose of Engerix-B Kinder vaccine | Solicited local symptoms assessed were pain, redness and swelling. Any was occurrence of any local symptom regardless of their intensity grade. Grade 3 pain was considerable pain at rest that prevented normal everyday activities. Grade 3 redness and swelling was \> 50 millimeter (mm). |
Countries
Germany
Participant flow
Recruitment details
A total of 300 subjects were enrolled in the study. Among them 297 subjects were included in the Total Vaccinated cohort. Remaining 3 subjects were not included as they failed to meet protocol specified criteria and as such they are not included in the Participant Flow as Started.
Participants by arm
| Arm | Count |
|---|---|
| Engerix-B Kinder Group Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age. | 297 |
| Total | 297 |
Baseline characteristics
| Characteristic | Engerix-B Kinder Group |
|---|---|
| Age, Continuous | 7.5 Years STANDARD_DEVIATION 0.52 |
| Sex: Female, Male Female | 144 Participants |
| Sex: Female, Male Male | 153 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 164 / 297 |
| serious Total, serious adverse events | 2 / 297 |
Outcome results
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-HBs enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of anti-HBs antibodies (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.
Time frame: One month (Month 1) after a challenge dose of Engerix-B Kinder vaccine
Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who had received a challenge dose of Engerix-B Kinder vaccine and for whom immunogenicity data were available at the post- Engerix-B Kinder challenge time point.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Engerix-B Kinder Group | Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 100 Milli-International Units Per Milliliter (mIU/mL) | 251 Participants |
Secondary
Anti-HBs Antibody Concentrations
Antibody concentrations are expressed as Geometric mean antibody concentrations (GMCs) in mIU/mL. A decrease in the specificity of the anti-HBs 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.
Time frame: One month (Month 1) after a challenge dose of Engerix-B Kinder vaccine
Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who had received a challenge dose of Engerix-B Kinder vaccine and for whom immunogenicity data were available at the post- Engerix-B Kinder challenge time point.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Engerix-B Kinder Group | Anti-HBs Antibody Concentrations | 4819.1 mIU/mL |
Secondary
Anti-HBs Antibody Concentrations After Previous Vaccination With Infanrix Hexa Vaccine.
Antibody concentrations are expressed as Geometric mean antibody concentrations (GMCs) in mIU/mL. A decrease in the specificity of the anti-HBs ELISA had been observed in some studies for low levels of anti-HBs antibodies (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.
Time frame: Before (Day 0) a challenge dose of Engerix-B Kinder vaccine
Population: Analysis was performed on According-to-Protocol (ATP) cohort for persistence which included all subjects previously primed and boosted with 4 doses of Infanrix hexa in the first 2 years of life; with no evidence of hepatitis B infection or disease and for whom serological results were available at the pre- Engerix-B Kinder challenge time point.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Engerix-B Kinder Group | Anti-HBs Antibody Concentrations After Previous Vaccination With Infanrix Hexa Vaccine. | 36.6 mIU/mL |
Secondary
Number of Subjects Demonstrating an Anamnestic Response to the Engerix-B Kinder Challenge Dose
The anamnestic response is defined as an antibody concentration ≥ 10 mIU/mL at post Engerix-B Kinder challenge dose time point for initially seronegative subjects ,and as an antibody concentration at post Engerix-B Kinder challenge dose time point ≥ 4 fold the pre-vaccination antibody concentration for initially seropositive subjects. A seropositive/seronegative subject was defined as subject with HBs antibody concentration below/greater than or equal to the seropositivity cut-off of 6.2 mIU/mL. A decrease in the specificity of the anti-HBs 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.
Time frame: After Engerix-B Kinder challenge dose (Month 1)
Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who had received a challenge dose of Engerix-B Kinder vaccine and for whom immunogenicity data were available at the post- Engerix-B Kinder challenge time point.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Engerix-B Kinder Group | Number of Subjects Demonstrating an Anamnestic Response to the Engerix-B Kinder Challenge Dose | 253 Participants |
Secondary
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Solicited local symptoms assessed were pain, redness and swelling. Any was occurrence of any local symptom regardless of their intensity grade. Grade 3 pain was considerable pain at rest that prevented normal everyday activities. Grade 3 redness and swelling was \> 50 millimeter (mm).
Time frame: During the 4-day (Day 0-3) follow-up period after the challenge dose of Engerix-B Kinder vaccine
Population: Analysis was performed on Total Vaccinated cohort which included all subjects who received the challenge dose of Engerix-B Kinder vaccine .
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Engerix-B Kinder Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any pain | 91 Participants |
| Engerix-B Kinder Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 pain | 2 Participants |
| Engerix-B Kinder Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any redness | 84 Participants |
| Engerix-B Kinder Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 redness | 0 Participants |
| Engerix-B Kinder Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any swelling | 49 Participants |
| Engerix-B Kinder Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 swelling | 0 Participants |
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and temeperature. Any temperature was defined as axillary temperature ≥ 37.5 degree centigrade (°C), grade 3 temperature was axillary temperature \> 39.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination.
Time frame: During the 4-day (Day 0-3) follow-up period after the challenge dose of Engerix-B Kinder vaccine
Population: Analysis was performed on Total Vaccinated cohort which included all subjects who received the challenge dose of Engerix-B Kinder vaccine.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Engerix-B Kinder Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any fatigue | 37 Participants |
| Engerix-B Kinder Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 fatigue | 1 Participants |
| Engerix-B Kinder Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related fatigue | 21 Participants |
| Engerix-B Kinder Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any gastrointestinal symptoms | 27 Participants |
| Engerix-B Kinder Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 gastrointestinal symptoms | 5 Participants |
| Engerix-B Kinder Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related gastrointestinal symptoms | 5 Participants |
| Engerix-B Kinder Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any headache | 36 Participants |
| Engerix-B Kinder Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 headache | 2 Participants |
| Engerix-B Kinder Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related headache | 15 Participants |
| Engerix-B Kinder Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any temperature | 14 Participants |
| Engerix-B Kinder Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 temperature | 0 Participants |
| Engerix-B Kinder Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related temperature | 11 Participants |
Secondary
Number of Subjects Reporting Any 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. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.
Time frame: After the challenge dose of Engerix-B Kinder vaccine up to the study end (Day 0 to Month 1)
Population: Analysis was performed on Total Vaccinated cohort which included all subjects who received the challenge dose of Engerix-B Kinder vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Engerix-B Kinder Group | Number of Subjects Reporting Any Serious Adverse Events (SAEs) | 2 Participants |
Secondary
Number of Subjects Reporting Any Unsolicited 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. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Time frame: During the 31-day (Day 0-30) follow-up period after the challenge dose of Engerix-B Kinder vaccine
Population: Analysis was performed on Total Vaccinated cohort which included all subjects who received the challenge dose of Engerix-B Kinder vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Engerix-B Kinder Group | Number of Subjects Reporting Any Unsolicited AEs | 42 Participants |
Secondary
Number of Subjects With Anti-HBs Antibody Concentrations Equal to or Above Protocol Specified Cut-off Values
Anti-HBs antibody concentrations cut-off values assessed were ≥ 6.2 mIU/mL (previously 3.3 mIU/mL) and ≥ 10 mIU/mL. A decrease in the specificity of the anti-HBs ELISA had been observed in some studies for low levels of anti-HBs antibodies (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.
Time frame: One month (Month 1) after a challenge dose of Engerix-B Kinder vaccine
Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who had received a challenge dose of Engerix-B Kinder vaccine and for whom immunogenicity data were available at the post- Engerix-B Kinder challenge time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Engerix-B Kinder Group | Number of Subjects With Anti-HBs Antibody Concentrations Equal to or Above Protocol Specified Cut-off Values | Anti-HBs antibody ≥ 6.2 mIU/mL | 259 Participants |
| Engerix-B Kinder Group | Number of Subjects With Anti-HBs Antibody Concentrations Equal to or Above Protocol Specified Cut-off Values | Anti-HBs antibody ≥ 10 mIU/mL | 259 Participants |
Secondary
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
Anti-HBs antibody concentrations cut-off values assessed were ≥ 6.2 mIU/mL (previously 3.3 mIU/mL), ≥ 10 mIU/mL, ≥ 10 mIU/mL to \<100 mIU/mL and ≥ 100 mIU/mL. A decrease in the specificity of the anti-HBs ELISA had been observed in some studies for low levels of anti-HBs antibodies (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.
Time frame: Before (Day 0) a challenge dose of Engerix-B Kinder vaccine
Population: Analysis was performed on According-to-Protocol (ATP) cohort for persistence which included all subjects previously primed and boosted with 4 doses of Infanrix hexa in the first 2 years of life; with no evidence of hepatitis B infection or disease and for whom serological results were available at the pre- Engerix-B Kinder challenge time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Engerix-B Kinder Group | 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 | Anti-HBs antibody ≥ 10 mIU/mL | 207 Participants |
| Engerix-B Kinder Group | 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 | Anti-HBs antibody ≥ 6.2 mIU/mL | 225 Participants |
| Engerix-B Kinder Group | 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 | Anti-HBs antibody between ≥ 10 and < 100 mIU/mL | 118 Participants |
| Engerix-B Kinder Group | 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 | Anti-HBs antibody ≥ 100 mIU/mL | 89 Participants |