Trial Outcomes & Findings for Evaluation of Antibody Persistence and Immune Memory Against the Hepatitis B Antigen in Previously Vaccinated Children (NCT NCT01138098)
NCT ID: NCT01138098
Last Updated: 2018-08-20
Results Overview
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.
COMPLETED
PHASE4
185 participants
One month after a challenge dose of Engerix-B vaccine
2018-08-20
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
95
|
90
|
|
Overall Study
COMPLETED
|
95
|
90
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Infanrix-hexa/Engerix-B Group
n=95 Participants
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.
|
Infanrix-IPV+Hib/Engerix-B Group
n=90 Participants
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.
|
Total
n=185 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
11.3 Years
STANDARD_DEVIATION 0.46 • n=95 Participants
|
11.3 Years
STANDARD_DEVIATION 0.47 • n=90 Participants
|
11.3 Years
STANDARD_DEVIATION 0.47 • n=185 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=95 Participants
|
35 Participants
n=90 Participants
|
80 Participants
n=185 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=95 Participants
|
55 Participants
n=90 Participants
|
105 Participants
n=185 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: One month after a challenge dose of Engerix-B vaccinePopulation: 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.
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.
Outcome measures
| Measure |
Infanrix-hexa/Engerix-B Group
n=94 Participants
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.
|
Infanrix-IPV+Hib/Engerix-B Group
n=89 Participants
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.
|
|---|---|---|
|
Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 100 Milli-International Units Per Milliliter (mIU/mL)
|
88 Participants
|
84 Participants
|
SECONDARY outcome
Timeframe: Before and one month after a challenge dose of Engerix-B vaccinePopulation: 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.
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.
Outcome measures
| Measure |
Infanrix-hexa/Engerix-B Group
n=94 Participants
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.
|
Infanrix-IPV+Hib/Engerix-B Group
n=89 Participants
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.
|
|---|---|---|
|
Number of Subjects With an Anamnestic Response to a Challenge Dose
|
91 Participants
|
86 Participants
|
SECONDARY outcome
Timeframe: Before and one month after a challenge dose of Engerix-B vaccinePopulation: 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.
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.
Outcome measures
| Measure |
Infanrix-hexa/Engerix-B Group
n=95 Participants
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.
|
Infanrix-IPV+Hib/Engerix-B Group
n=89 Participants
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.
|
|---|---|---|
|
Number of Subjects With Anti-HBs Antibody Concentration ≥ 6.2 mIU/mL
≥ 6.2 mIU/mL [pre-challenge dose]
|
53 Participants
|
57 Participants
|
|
Number of Subjects With Anti-HBs Antibody Concentration ≥ 6.2 mIU/mL
≥ 6.2 mIU/mL [post-challenge dose]
|
92 Participants
|
88 Participants
|
SECONDARY outcome
Timeframe: Before and one month after a challenge dose of Engerix-B vaccinePopulation: 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.
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.
Outcome measures
| Measure |
Infanrix-hexa/Engerix-B Group
n=95 Participants
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.
|
Infanrix-IPV+Hib/Engerix-B Group
n=89 Participants
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.
|
|---|---|---|
|
Number of Subjects With Anti-HBs Antibody Concentration ≥ 10 mIU/mL
≥ 10 mIU/mL [pre-challenge dose]
|
46 Participants
|
52 Participants
|
|
Number of Subjects With Anti-HBs Antibody Concentration ≥ 10 mIU/mL
≥ 10 mIU/mL [post-challenge dose]
|
91 Participants
|
88 Participants
|
SECONDARY outcome
Timeframe: Before the challenge dose of Engerix-B vaccinePopulation: 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.
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.
Outcome measures
| Measure |
Infanrix-hexa/Engerix-B Group
n=95 Participants
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.
|
Infanrix-IPV+Hib/Engerix-B Group
n=89 Participants
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.
|
|---|---|---|
|
Number of Subjects With Anti-HBs Antibody Concentration ≥ 100 mIU/mL
|
14 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) follow-up period after a challenge dose of Engerix-B vaccinePopulation: The Total Vaccinated cohort included all subjects who received the challenge dose of Engerix-B vaccine.
Solicited local symptoms assessed were pain, redness and swelling.
Outcome measures
| Measure |
Infanrix-hexa/Engerix-B Group
n=95 Participants
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.
|
Infanrix-IPV+Hib/Engerix-B Group
n=90 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting Solicited Local Symptoms
Pain
|
30 Participants
|
24 Participants
|
|
Number of Subjects Reporting Solicited Local Symptoms
Redness
|
25 Participants
|
22 Participants
|
|
Number of Subjects Reporting Solicited Local Symptoms
Swelling
|
15 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) follow-up period after a challenge dose of Engerix-B vaccinePopulation: The Total Vaccinated cohort included all subjects who received the challenge dose of Engerix-B vaccine.
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)).
Outcome measures
| Measure |
Infanrix-hexa/Engerix-B Group
n=95 Participants
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.
|
Infanrix-IPV+Hib/Engerix-B Group
n=90 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting Solicited General Symptoms
Fatigue
|
23 Participants
|
22 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Gastrointestinal
|
9 Participants
|
9 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Headache
|
19 Participants
|
14 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Temperature ≥ 37.5°C
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: During the 31-day (Days 0-30) follow-up period after a challenge dose of Engerix-B vaccinePopulation: The Total Vaccinated cohort included all subjects who received the challenge dose of Engerix-B vaccine.
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.
Outcome measures
| Measure |
Infanrix-hexa/Engerix-B Group
n=95 Participants
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.
|
Infanrix-IPV+Hib/Engerix-B Group
n=90 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
|
5 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: After the challenge dose of Engerix-B vaccine up to the study endPopulation: The Total Vaccinated cohort included all subjects who received the challenge dose of Engerix-B vaccine.
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.
Outcome measures
| Measure |
Infanrix-hexa/Engerix-B Group
n=95 Participants
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.
|
Infanrix-IPV+Hib/Engerix-B Group
n=90 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting Serious Adverse Events (SAEs)
|
1 Participants
|
0 Participants
|
Adverse Events
Infanrix-hexa/Engerix-B Group
Infanrix-IPV+Hib/Engerix-B Group
Serious adverse events
| Measure |
Infanrix-hexa/Engerix-B Group
n=95 participants at risk
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.
|
Infanrix-IPV+Hib/Engerix-B Group
n=90 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Infection
|
1.1%
1/95 • 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
|
0.00%
0/90 • 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
|
Other adverse events
| Measure |
Infanrix-hexa/Engerix-B Group
n=95 participants at risk
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.
|
Infanrix-IPV+Hib/Engerix-B Group
n=90 participants at risk
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.
|
|---|---|---|
|
General disorders
Pain
|
31.6%
30/95 • 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
|
26.7%
24/90 • 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
|
|
General disorders
Redness
|
26.3%
25/95 • 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
|
24.4%
22/90 • 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
|
|
General disorders
Swelling
|
15.8%
15/95 • 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
|
8.9%
8/90 • 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
|
|
General disorders
Fatigue
|
24.2%
23/95 • 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
|
24.4%
22/90 • 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
|
|
General disorders
Gastrointestinal
|
9.5%
9/95 • 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
|
10.0%
9/90 • 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
|
|
General disorders
Headache
|
20.0%
19/95 • 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
|
15.6%
14/90 • 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
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER