Hepatitis B Antibody Persistence and Immune Response to Hepatitis B Vaccine Challenge in Previously Vaccinated Children
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Biological: Engerix-B™ Kinder
Intramuscular, single dose
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 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.
- 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).
- 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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | GSK Investigational Site | Bad Saulgau | Baden-Wuerttemberg | Germany | 88348 |
| 2 | GSK Investigational Site | Kehl | Baden-Wuerttemberg | Germany | 77694 |
| 3 | GSK Investigational Site | Oberstenfeld | Baden-Wuerttemberg | Germany | 71720 |
| 4 | GSK Investigational Site | Stuttgart | Baden-Wuerttemberg | Germany | 70469 |
| 5 | GSK Investigational Site | Tuttlingen | Baden-Wuerttemberg | Germany | 78532 |
| 6 | GSK Investigational Site | Bindlach | Bayern | Germany | 95463 |
| 7 | GSK Investigational Site | Kempten | Bayern | Germany | 87435 |
| 8 | GSK Investigational Site | Braunatal | Hessen | Germany | 34225 |
| 9 | GSK Investigational Site | Muenster | Nordrhein-Westfalen | Germany | 48163 |
| 10 | GSK Investigational Site | Frankenthal | Rheinland-Pfalz | Germany | 67227 |
| 11 | GSK Investigational Site | Worms | Rheinland-Pfalz | Germany | 67547 |
| 12 | GSK Investigational Site | Berlin | Germany | 13055 |
Sponsors and Collaborators
- GlaxoSmithKline
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 112688
Study Results
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. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Engerix-B Kinder Group |
|---|---|
| Arm/Group Description | 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. |
| Period Title: Overall Study | |
| STARTED | 297 |
| COMPLETED | 297 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Engerix-B Kinder Group |
|---|---|
| Arm/Group Description | 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. |
| Overall Participants | 297 |
| Age (Years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [Years] |
7.5
(0.52)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
144
48.5%
|
| Male |
153
51.5%
|
Outcome Measures
| Title | Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 100 Milli-International Units Per Milliliter (mIU/mL) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Engerix-B Kinder Group |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 262 |
| Count of Participants [Participants] |
251
84.5%
|
| Title | Anti-HBs Antibody Concentrations After Previous Vaccination With Infanrix Hexa Vaccine. |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Engerix-B Kinder Group |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 287 |
| Geometric Mean (95% Confidence Interval) [mIU/mL] |
36.6
|
| Title | 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 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Engerix-B Kinder Group |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 287 |
| Anti-HBs antibody ≥ 6.2 mIU/mL |
225
75.8%
|
| Anti-HBs antibody ≥ 10 mIU/mL |
207
69.7%
|
| Anti-HBs antibody between ≥ 10 and < 100 mIU/mL |
118
39.7%
|
| Anti-HBs antibody ≥ 100 mIU/mL |
89
30%
|
| Title | Number of Subjects With Anti-HBs Antibody Concentrations Equal to or Above Protocol Specified Cut-off Values |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Engerix-B Kinder Group |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 262 |
| Anti-HBs antibody ≥ 6.2 mIU/mL |
259
87.2%
|
| Anti-HBs antibody ≥ 10 mIU/mL |
259
87.2%
|
| Title | Anti-HBs Antibody Concentrations |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Engerix-B Kinder Group |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 282 |
| Geometric Mean (95% Confidence Interval) [mIU/mL] |
4819.1
|
| Title | Number of Subjects Demonstrating an Anamnestic Response to the Engerix-B Kinder Challenge Dose |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Engerix-B Kinder Group |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 262 |
| Count of Participants [Participants] |
253
85.2%
|
| Title | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on Total Vaccinated cohort which included all subjects who received the challenge dose of Engerix-B Kinder vaccine . |
| Arm/Group Title | Engerix-B Kinder Group |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 297 |
| Any pain |
91
30.6%
|
| Grade 3 pain |
2
0.7%
|
| Any redness |
84
28.3%
|
| Grade 3 redness |
0
0%
|
| Any swelling |
49
16.5%
|
| Grade 3 swelling |
0
0%
|
| Title | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on Total Vaccinated cohort which included all subjects who received the challenge dose of Engerix-B Kinder vaccine. |
| Arm/Group Title | Engerix-B Kinder Group |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 297 |
| Any fatigue |
37
12.5%
|
| Grade 3 fatigue |
1
0.3%
|
| Related fatigue |
21
7.1%
|
| Any gastrointestinal symptoms |
27
9.1%
|
| Grade 3 gastrointestinal symptoms |
5
1.7%
|
| Related gastrointestinal symptoms |
5
1.7%
|
| Any headache |
36
12.1%
|
| Grade 3 headache |
2
0.7%
|
| Related headache |
15
5.1%
|
| Any temperature |
14
4.7%
|
| Grade 3 temperature |
0
0%
|
| Related temperature |
11
3.7%
|
| Title | Number of Subjects Reporting Any Unsolicited 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. 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on Total Vaccinated cohort which included all subjects who received the challenge dose of Engerix-B Kinder vaccine. |
| Arm/Group Title | Engerix-B Kinder Group |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 297 |
| Count of Participants [Participants] |
42
14.1%
|
| Title | Number of Subjects Reporting Any 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. 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on Total Vaccinated cohort which included all subjects who received the challenge dose of Engerix-B Kinder vaccine. |
| Arm/Group Title | Engerix-B Kinder Group |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 297 |
| Count of Participants [Participants] |
2
0.7%
|
Adverse Events
| Time Frame | Serious adverse events were assessed from Day 0 to Month 1. Systematically assessed frequent adverse events were assessed during the 4-day post vaccination period. | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Engerix-B Kinder Group | |
| Arm/Group Description | 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. | |
All Cause Mortality |
||
| Engerix-B Kinder Group | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Engerix-B Kinder Group | ||
| Affected / at Risk (%) | # Events | |
| Total | 2/297 (0.7%) | |
| Immune system disorders | ||
| Hypersensitivity | 1/297 (0.3%) | |
| Infections and infestations | ||
| Lyme disease | 1/297 (0.3%) | |
| Nervous system disorders | ||
| VIIth nerve paralysis | 1/297 (0.3%) | |
Other (Not Including Serious) Adverse Events |
||
| Engerix-B Kinder Group | ||
| Affected / at Risk (%) | # Events | |
| Total | 164/297 (55.2%) | |
| General disorders | ||
| Pain | 91/297 (30.6%) | |
| Redness | 84/297 (28.3%) | |
| Swelling | 49/297 (16.5%) | |
| Fatigue | 37/297 (12.5%) | |
| Gastrointestinal symptoms | 27/297 (9.1%) | |
| Headache | 36/297 (12.1%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | GSK Response Center |
|---|---|
| Organization | GlaxoSmithKline |
| Phone | 866-435-7343 |
- 112688