Trial Outcomes & Findings for This Study Aims to Determine the Long-term Persistence of Antibodies Against Hepatitis B and to Evaluate the Immunogenicity and Safety of Hepatitis B Vaccine in Adolescents Vaccinated in Infancy With Infanrix™ Hexa (NCT NCT02052661)

Results Overview

Anti-HBs immune response was defined as the number of subjects with Anti-HBs antibody concentrations ≥ 100 mIU/ml.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

301 participants

Primary outcome timeframe

One month after the single challenge dose of Engerix-B Kinder vaccine (Month 1)

Results posted on

2018-06-06

Participant Flow

301 subjects were enrolled in the study but one subject was withdrawn before any study procedure.

Participant milestones

Participant milestones
Measure	Engerix-B Kinder Group Subjects who were previously primed and boosted with four doses of Infanrix hexa in the first two years of life, received a single dose of Engerix-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Overall Study STARTED	300
Overall Study COMPLETED	300
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

This Study Aims to Determine the Long-term Persistence of Antibodies Against Hepatitis B and to Evaluate the Immunogenicity and Safety of Hepatitis B Vaccine in Adolescents Vaccinated in Infancy With Infanrix™ Hexa

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Engerix-B Kinder Group n=300 Participants Subjects who were previously primed and boosted with four doses of Infanrix hexa in the first two years of life, received a single dose of Engerix-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Age, Continuous	12.3 Years STANDARD_DEVIATION 0.5 • n=5 Participants
Sex: Female, Male Female	150 Participants n=5 Participants
Sex: Female, Male Male	150 Participants n=5 Participants

PRIMARY outcome

Timeframe: One month after the single challenge dose of Engerix-B Kinder vaccine (Month 1)

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.

Anti-HBs immune response was defined as the number of subjects with Anti-HBs antibody concentrations ≥ 100 mIU/ml.

Outcome measures

Outcome measures
Measure	Engerix-B Kinder Group n=289 Participants Subjects who were previously primed and boosted with four doses of Infanrix hexa in the first two years of life, received a single dose of Engerix-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Anti-HBs Immune Response	272 Subject

SECONDARY outcome

Timeframe: Before (PRE) and 1 month after (POST) the single challenge dose of Engerix-B Kinder vaccine.

Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects, aged 12-13 years at the time of enrolment, who did not received any additional dose of hepatitis B vaccine other than four doses of Infanrix hexa during first two years of life, for whom the serological results were available.

Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of 6.2 mIU/ml.

Outcome measures

Outcome measures
Measure	Engerix-B Kinder Group n=293 Participants Subjects who were previously primed and boosted with four doses of Infanrix hexa in the first two years of life, received a single dose of Engerix-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Anti-HBs Antibody Concentrations at 12-13 Years of Age, After Previous Vaccination With Infanrix Hexa. Anti-HBs, PRE	22.7 mIU/mL Interval 18.5 to 27.9
Anti-HBs Antibody Concentrations at 12-13 Years of Age, After Previous Vaccination With Infanrix Hexa. Anti-HBs, POST	3502.6 mIU/mL Interval 2672.0 to 4591.5

SECONDARY outcome

Timeframe: Before the single challenge dose of Engerix-B Kinder vaccine.

Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects, aged 12-13 years at the time of enrolment, who did not received any additional dose of hepatitis B vaccine other than four doses of Infanrix hexa during first two years of life, for whom the serological results were available.

A seropositive subject was defined as a subject with anti-HBs antibody concentrations ≥ 6.2 milli-international units per milliliter (mIU/ml). A seroprotected subjects was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/ml.

Outcome measures

Outcome measures
Measure	Engerix-B Kinder Group n=293 Participants Subjects who were previously primed and boosted with four doses of Infanrix hexa in the first two years of life, received a single dose of Engerix-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Number of Subjects With Anti-HBs Antibody Concentrations ≥ 6.2 mIU/ml, ≥ 10 mIU/ml, 10 to < 100 mIU/ml and ≥ 100 mIU/ml. Anti-HBs ≥ 6.2 mIU/ml	205 Subject
Number of Subjects With Anti-HBs Antibody Concentrations ≥ 6.2 mIU/ml, ≥ 10 mIU/ml, 10 to < 100 mIU/ml and ≥ 100 mIU/ml. Anti-HBs ≥ 10 mIU/ml	178 Subject
Number of Subjects With Anti-HBs Antibody Concentrations ≥ 6.2 mIU/ml, ≥ 10 mIU/ml, 10 to < 100 mIU/ml and ≥ 100 mIU/ml. Anti-HBs 10 to < 100 mIU/ml	116 Subject
Number of Subjects With Anti-HBs Antibody Concentrations ≥ 6.2 mIU/ml, ≥ 10 mIU/ml, 10 to < 100 mIU/ml and ≥ 100 mIU/ml. Anti-HBs ≥ 100 mIU/ml	62 Subject

SECONDARY outcome

Timeframe: 1 month after the single challenge dose of Engerix-B Kinder vaccine.

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.

A seropositive subject was defined as a subject with anti-HBs antibody concentrations ≥ 6.2 mIU/ml. A seroprotected subjects was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/ml.

Outcome measures

Outcome measures
Measure	Engerix-B Kinder Group n=289 Participants Subjects who were previously primed and boosted with four doses of Infanrix hexa in the first two years of life, received a single dose of Engerix-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Number of Subjects With Anti-HBs Antibody Concentrations ≥ 6.2 mIU/ml and ≥ 10 mIU/ml. Anti-HBs ≥ 6.2 mIU/ml	283 Subject
Number of Subjects With Anti-HBs Antibody Concentrations ≥ 6.2 mIU/ml and ≥ 10 mIU/ml. Anti-HBs ≥ 10 mIU/ml	282 Subject

SECONDARY outcome

Timeframe: One month after the single challenge dose of Engerix-B Kinder vaccine.

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.

The amnestic response to the challenge dose was defined as: for initially seronegative subjects, antibody concentration ≥ 10mIU/mL; for initially seropositive subjects, antibody concentration at least four times the pre-challenge antibody concentration.

Outcome measures

Outcome measures
Measure	Engerix-B Kinder Group n=287 Participants Subjects who were previously primed and boosted with four doses of Infanrix hexa in the first two years of life, received a single dose of Engerix-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Number of Subjects With an Anamnestic Response to the Single Challenge Dose of Engerix-B Kinder Vaccine.	277 Subject

SECONDARY outcome

Timeframe: During the 4-day (Day 0-3) follow-up period after the single challenge dose of Engerix-B Kinder vaccine.

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.

Outcome measures

Outcome measures
Measure	Engerix-B Kinder Group n=300 Participants Subjects who were previously primed and boosted with four doses of Infanrix hexa in the first two years of life, received a single dose of Engerix-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Number of Subjects With Any Solicited Local Symptoms. Pain	132 Subject
Number of Subjects With Any Solicited Local Symptoms. Redness	70 Subject
Number of Subjects With Any Solicited Local Symptoms. Swelling	29 Subject

SECONDARY outcome

Timeframe: During the 4-day (Day 0-3) follow-up period after the single challenge dose of Engerix-B Kinder vaccine.

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.

Assessed solicited general symptoms were fatigue, gastrointestinal, headache and temperature \[defined as axillary temperature equal to oe above 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade.

Outcome measures

Outcome measures
Measure	Engerix-B Kinder Group n=300 Participants Subjects who were previously primed and boosted with four doses of Infanrix hexa in the first two years of life, received a single dose of Engerix-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Number of Subjects With Any Solicited General Symptoms. Fatigue	73 Subject
Number of Subjects With Any Solicited General Symptoms. Gastrointestinal	34 Subject
Number of Subjects With Any Solicited General Symptoms. Headache	71 Subject
Number of Subjects With Any Solicited General Symptoms. Temperature/(Axillary)	7 Subject

SECONDARY outcome

Timeframe: During the 31-day (Day 0-30) follow-up period after the single challenge dose of Engerix-B Kinder vaccine.

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

Outcome measures

Outcome measures
Measure	Engerix-B Kinder Group n=300 Participants Subjects who were previously primed and boosted with four doses of Infanrix hexa in the first two years of life, received a single dose of Engerix-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Number of Subjects With Any Unsolicited Adverse Events (AEs).	44 Subject

SECONDARY outcome

Timeframe: From Month 0 to Month 1

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Outcome measures
Measure	Engerix-B Kinder Group n=300 Participants Subjects who were previously primed and boosted with four doses of Infanrix hexa in the first two years of life, received a single dose of Engerix-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Number of Subjects With Serious Adverse Events (SAEs).	2 Subject

Adverse Events

Engerix-B Kinder Group

Serious events: 2 serious events

Other events: 200 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Engerix-B Kinder Group n=300 participants at risk Subjects who were previously primed and boosted with four doses of Infanrix hexa in the first two years of life, received a single dose of Engerix-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Injury, poisoning and procedural complications Contusion	0.33% 1/300 • Solicited symptoms: during the 4-day (Day 0-3) follow-up period after vaccination Unsolicited AEs: during the 31-day (Day 0-30) follow-up period after vaccination SAEs: During the entire study. The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
Injury, poisoning and procedural complications Forearm fracture	0.33% 1/300 • Solicited symptoms: during the 4-day (Day 0-3) follow-up period after vaccination Unsolicited AEs: during the 31-day (Day 0-30) follow-up period after vaccination SAEs: During the entire study. The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.

Other adverse events

Other adverse events
Measure	Engerix-B Kinder Group n=300 participants at risk Subjects who were previously primed and boosted with four doses of Infanrix hexa in the first two years of life, received a single dose of Engerix-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
General disorders Pain	44.0% 132/300 • Solicited symptoms: during the 4-day (Day 0-3) follow-up period after vaccination Unsolicited AEs: during the 31-day (Day 0-30) follow-up period after vaccination SAEs: During the entire study. The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
General disorders Redness	23.3% 70/300 • Solicited symptoms: during the 4-day (Day 0-3) follow-up period after vaccination Unsolicited AEs: during the 31-day (Day 0-30) follow-up period after vaccination SAEs: During the entire study. The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
General disorders Swelling	9.7% 29/300 • Solicited symptoms: during the 4-day (Day 0-3) follow-up period after vaccination Unsolicited AEs: during the 31-day (Day 0-30) follow-up period after vaccination SAEs: During the entire study. The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
General disorders Fatigue	24.3% 73/300 • Solicited symptoms: during the 4-day (Day 0-3) follow-up period after vaccination Unsolicited AEs: during the 31-day (Day 0-30) follow-up period after vaccination SAEs: During the entire study. The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
General disorders Gastrointestinal	11.3% 34/300 • Solicited symptoms: during the 4-day (Day 0-3) follow-up period after vaccination Unsolicited AEs: during the 31-day (Day 0-30) follow-up period after vaccination SAEs: During the entire study. The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
General disorders Headache	23.7% 71/300 • Solicited symptoms: during the 4-day (Day 0-3) follow-up period after vaccination Unsolicited AEs: during the 31-day (Day 0-30) follow-up period after vaccination SAEs: During the entire study. The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.

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