Trial Outcomes & Findings for Persistence of Immunity Against Hepatitis B in 12-13 Year Old Adolescents After Infant Hepatitis B Vaccination (NCT NCT00984139)

NCT ID: NCT00984139

Last Updated: 2018-08-20

Results Overview

The cut-off value was defined as 100 milli-international units per milliliter (mIU/mL).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 306 participants
• Primary outcome timeframe: One month after the challenge dose (Month 1)
• Results posted on: 2018-08-20

Participant Flow

Participant milestones

Measure	Engerix-B Group Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
Overall Study STARTED	306
Overall Study COMPLETED	306
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Engerix-B Group n=306 Participants Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
Age, Continuous	12.4 Years STANDARD_DEVIATION 0.49 • n=5 Participants
Sex: Female, Male Female	152 Participants n=5 Participants
Sex: Female, Male Male	154 Participants n=5 Participants

PRIMARY outcome

Timeframe: One month after the challenge dose (Month 1)

Population: The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of Engerix-B and for whom data concerning immunogenicity outcome measures were available at the time point after the Engerix-B challenge dose.

The cut-off value was defined as 100 milli-international units per milliliter (mIU/mL).

Outcome measures

Measure	Engerix-B Group n=284 Participants Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations as Measured by ELISA Equal to or Above Cut-off Value	266 Participants

PRIMARY outcome

Timeframe: One month after the challenge dose (Month 1)

Population: The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of Engerix-B and for whom data concerning immunogenicity outcome measures were available at the time point after the Engerix-B challenge dose.

The cut-off value was defined as 100 milli-international units per milliliter (mIU/mL).

Outcome measures

Measure	Engerix-B Group n=276 Participants Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations as Measured by ChemiLuminescence ImmunoAssay (CLIA) Equal to or Above Cut-off Value.	257 Participants

SECONDARY outcome

Timeframe: Before (Day 0) and one month (Month 1) after the challenge dose

Population: The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of Engerix-B and for whom data concerning immunogenicity outcome measures were available at the time point after the Engerix-B challenge dose.

The cut-off values were defined as 3.3 mIU/mL, 10 mIU/mL and 100 mIU/mL.

Note: the number of subjects with anti-HBs antibody concentrations equal to or above 100 mIU/mL on month post-challenge dose data are presented as a primary outcome measure.

Outcome measures

Measure	Engerix-B Group n=284 Participants Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
Number of Subjects With Anti-HBs Antibody Concentrations as Measured by ELISA Equal to or Above Cut-off Values pre challenge dose 3.3 mIU/mL	259 Participants
Number of Subjects With Anti-HBs Antibody Concentrations as Measured by ELISA Equal to or Above Cut-off Values post challenge dose 3.3 mIU/mL	283 Participants
Number of Subjects With Anti-HBs Antibody Concentrations as Measured by ELISA Equal to or Above Cut-off Values pre challenge dose 10 mIU/mL	220 Participants
Number of Subjects With Anti-HBs Antibody Concentrations as Measured by ELISA Equal to or Above Cut-off Values post challenge dose 10 mIU/mL	281 Participants
Number of Subjects With Anti-HBs Antibody Concentrations as Measured by ELISA Equal to or Above Cut-off Values pre challenge dose 100 mIU/mL	70 Participants

SECONDARY outcome

Timeframe: Before (Day 0) and one month (Month 1) after the challenge dose

Population: The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of Engerix-B and for whom data concerning immunogenicity outcome measures were available at the time point after the Engerix-B challenge dose.

The cut-off values were defined as 6.2 mIU/mL, 10 mIU/mL and 100 mIU/mL. Note: the number of subjects with anti-HBs antibody concentrations equal to or above 100 mIU/mL on month post-challenge dose data are presented as a primary outcome measure.

Outcome measures

Measure	Engerix-B Group n=279 Participants Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
Number of Subjects With Anti-HBs Antibody Concentrations as Measured by CLIA Equal to or Above Cut-off Values pre challenge dose 6.2 mIU/mL	201 Participants
Number of Subjects With Anti-HBs Antibody Concentrations as Measured by CLIA Equal to or Above Cut-off Values post challenge dose 6.2 mIU/mL	271 Participants
Number of Subjects With Anti-HBs Antibody Concentrations as Measured by CLIA Equal to or Above Cut-off Values pre challenge dose 10 mIU/mL	181 Participants
Number of Subjects With Anti-HBs Antibody Concentrations as Measured by CLIA Equal to or Above Cut-off Values post challenge dose 10 mIU/mL	271 Participants
Number of Subjects With Anti-HBs Antibody Concentrations as Measured by CLIA Equal to or Above Cut-off Values pre challenge dose 100 mIU/mL	67 Participants

SECONDARY outcome

Timeframe: During the 4-day (Day 0-3) follow-up period following the challenge dose vaccination

Population: The analysis was performed on the Total Vaccinated cohort.

Solicited local symptoms were pain, redness and swelling. Solicited general symptoms were fatigue, gastrointestinal symptoms, headache and fever.

Fever was defined as axillary temperature greater than or equal to 37.5 degrees Celsius.

Outcome measures

Measure	Engerix-B Group n=306 Participants Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
Number of Subjects With Solicited Local and General Symptoms pain	104 Participants
Number of Subjects With Solicited Local and General Symptoms redness	56 Participants
Number of Subjects With Solicited Local and General Symptoms swelling	26 Participants
Number of Subjects With Solicited Local and General Symptoms fatigue	63 Participants
Number of Subjects With Solicited Local and General Symptoms gastrointestinal symptoms	14 Participants
Number of Subjects With Solicited Local and General Symptoms headache	56 Participants
Number of Subjects With Solicited Local and General Symptoms fever	9 Participants

SECONDARY outcome

Timeframe: During the 31-day (Day 0-30) follow-up period following the challenge dose vaccination

Population: The analysis was performed on the Total Vaccinated cohort.

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.

Outcome measures

Measure	Engerix-B Group n=306 Participants Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
Number of Subjects With Unsolicited Adverse Events (AEs)	64 Participants

SECONDARY outcome

Timeframe: After the challenge dose of the vaccine (Day 0) up to the study end (Month 1)

Population: The analysis was performed on the Total Vaccinated cohort.

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.

Outcome measures

Measure	Engerix-B Group n=306 Participants Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
Number of Subjects With Serious Adverse Events (SAEs)	0 Participants

SECONDARY outcome

Timeframe: One month after the challenge dose (Month 1)

Population: The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of Engerix-B and for whom data concerning immunogenicity outcome measures were available at the time point after the Engerix-B challenge dose.

Anamnestic response was defined as: - At least (i.e. greater than or equal to) a 4-fold rise in post-challenge vaccine dose anti-HBs antibody concentrations in subjects seropositive (i.e. with anti-HBs antibody concentration equal to or greater than 3.3 mIU/mL) at the pre-challenge dose time point. - Post-challenge dose anti-HBs antibody concentrations equal to or greater than 10 mIU/mL in subjects seronegative (i.e. with anti-HBs antibody concentrations less than 3.3 mIU/mL) at the pre-challenge dose time point.

Outcome measures

Measure	Engerix-B Group n=282 Participants Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
Number of Subjects With Anamnestic Response to the Challenge Dose as Measured by ELISA.	274 Participants

SECONDARY outcome

Timeframe: One month after the challenge dose (Month 1)

Population: The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of Engerix-B and for whom data concerning immunogenicity outcome measures were available at the time point after the Engerix-B challenge dose.

Anamnestic response was defined as: - At least (i.e. greater than or equal to) a 4-fold rise in post-challenge vaccine dose anti-HBs antibody concentrations in subjects seropositive (i.e. with anti-HBs antibody concentration ≥ 6.2 mIU/mL) at the pre-challenge dose time point. - Post-challenge dose anti-HBs antibody concentrations equal to or greater than 10 mIU/mL in subjects seronegative (i.e. with anti-HBs antibody concentrations < 6.2 mIU/mL) at the pre-challenge dose time point.

Outcome measures

Measure	Engerix-B Group n=271 Participants Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
Number of Subjects With Anamnestic Response to the Challenge Dose as Measured by CLIA.	267 Participants

Adverse Events

Engerix-B Group

Serious events: 0 serious events

Other events: 170 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Engerix-B Group n=306 participants at risk Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
General disorders Pain	34.0% 104/306
General disorders Redness	18.3% 56/306
General disorders Swelling	8.5% 26/306
General disorders Fatigue	20.6% 63/306
General disorders Headache	18.3% 56/306

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

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