Trial Outcomes & Findings for A Study to Evaluate Persistence of Hepatitis B Antibodies, Immunogenicity and Safety of Engerix™-B Kinder Challenge Dose, in Adolescents Vaccinated With Four Doses of Infanrix™ Hexa During Infancy (NCT NCT02798952)

NCT ID: NCT02798952

Last Updated: 2020-01-18

Results Overview

Concentrations were expressed in geometric mean concentrations (GMCs).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 302 participants
• Primary outcome timeframe: At Day 30.
• Results posted on: 2020-01-18

Participant Flow

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 challenge dose of Engerix-B Kinder.
Overall Study STARTED	302
Overall Study COMPLETED	302
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate Persistence of Hepatitis B Antibodies, Immunogenicity and Safety of Engerix™-B Kinder Challenge Dose, in Adolescents Vaccinated With Four Doses of Infanrix™ Hexa During Infancy

Baseline characteristics by cohort

Measure	Engerix-B Kinder Group n=302 Participants Subjects, who were previously primed and boosted with four doses of Infanrix hexa in the first two years of life, received a single challenge dose of Engerix-B Kinder.
Age, Continuous	14.4 years STANDARD_DEVIATION 0.5 • n=5 Participants
Sex: Female, Male Female	142 Participants n=5 Participants
Sex: Female, Male Male	160 Participants n=5 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	1 Participants n=5 Participants
Race/Ethnicity, Customized White - Caucasian / European Heritage	293 Participants n=5 Participants
Race/Ethnicity, Customized African Heritage / African American	2 Participants n=5 Participants
Race/Ethnicity, Customized White - Arabic / North African Heritage	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Day 30.

Population: The analysis was based on the According-to-Protocol cohort for analyses of immunogenicity, which included all subjects who met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom post-vaccination immunogenicity results were available.

Concentrations were expressed in geometric mean concentrations (GMCs).

Outcome measures

Measure	Engerix-B Kinder Group n=268 Participants Subjects, who were previously primed and boosted with four doses of Infanrix hexa in the first two years of life, received a single challenge dose of Engerix-B Kinder.
Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations	1975.7 mIU/mL Interval 1436.1 to 2718.1

SECONDARY outcome

Timeframe: At Day 0

Population: The analysis was based on the According-to-Protocol cohort for analyses of immunogenicity, which included all subjects who met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom post-vaccination immunogenicity results were available.

Concentrations were expressed in geometric mean concentrations (GMCs).

Outcome measures

Measure	Engerix-B Kinder Group n=268 Participants Subjects, who were previously primed and boosted with four doses of Infanrix hexa in the first two years of life, received a single challenge dose of Engerix-B Kinder.
Anti-HBs Antibody Concentrations	15.6 mIU/mL Interval 12.8 to 19.1

SECONDARY outcome

Timeframe: At Day 0 and Day 30

Population: The analysis was based on the According-to-Protocol cohort for analyses of immunogenicity, which included all subjects who met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom post-vaccination immunogenicity results were available.

A seropositve subject was defined as a subject with anti-HBs antibody concentrations above the assay cut-off (≥ 6.2 mIU/ml).

Outcome measures

Measure	Engerix-B Kinder Group n=268 Participants Subjects, who were previously primed and boosted with four doses of Infanrix hexa in the first two years of life, received a single challenge dose of Engerix-B Kinder.
Number of Seropositive Subjects for Anti-HBs. At Day 0	163 Participants
Number of Seropositive Subjects for Anti-HBs. At Day 30	255 Participants

SECONDARY outcome

Timeframe: At Day 0 and day 30

Population: The analysis was based on the According-to-Protocol cohort for analyses of immunogenicity, which included all subjects who met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom post-vaccination immunogenicity results were available.

A seroprotected subject was defined as a subject with anti-HBs antibody concentrations equal to or above 10 milli-International units per milliliter (mIU/ml).

Outcome measures

Measure	Engerix-B Kinder Group n=268 Participants Subjects, who were previously primed and boosted with four doses of Infanrix hexa in the first two years of life, received a single challenge dose of Engerix-B Kinder.
Number of Seroprotected Subjects for Anti-HBs. At Day 0	144 Participants
Number of Seroprotected Subjects for Anti-HBs. At Day 30	250 Participants

SECONDARY outcome

Timeframe: At Day 0 and Day 30

Population: The analysis was based on the According-to-Protocol cohort for analyses of immunogenicity, which included all subjects who met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom post-vaccination immunogenicity results were available.

The cut-off of the assay was ≥ 100 mIU/mL.

Outcome measures

Measure	Engerix-B Kinder Group n=268 Participants Subjects, who were previously primed and boosted with four doses of Infanrix hexa in the first two years of life, received a single challenge dose of Engerix-B Kinder.
Number of Subjects With Anti-HBs Concentrations Above the Cut-off. At Day 0	45 Participants
Number of Subjects With Anti-HBs Concentrations Above the Cut-off. At Day 30	234 Participants

SECONDARY outcome

Timeframe: At Day 30

Population: The analysis was based on the According-to-Protocol cohort for analyses of immunogenicity, which included all subjects who met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom post-vaccination immunogenicity results were available.

Anamnestic response 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

Measure	Engerix-B Kinder Group n=268 Participants Subjects, who were previously primed and boosted with four doses of Infanrix hexa in the first two years of life, received a single challenge dose of Engerix-B Kinder.
Number of Subjects With an Anamnestic Response to the Hepatitis B Challenge Dose.	248 Participants

SECONDARY outcome

Timeframe: Within 4 days (Day 0 - Day 3) after the vaccination

Population: The analysis was based on the Total Vaccinated cohort, which included all subjects who received the study vaccine and had their symptoms sheet completed .

Solicited local symptoms assessed were pain, redness and swelling at injection site. Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and fever (defined as axillary temperature ≥ 37.5°C).

Outcome measures

Measure	Engerix-B Kinder Group n=301 Participants Subjects, who were previously primed and boosted with four doses of Infanrix hexa in the first two years of life, received a single challenge dose of Engerix-B Kinder.
Number of Subjects With Any Solicited Local and General Symptoms. Redness	65 Participants
Number of Subjects With Any Solicited Local and General Symptoms. Pain	101 Participants
Number of Subjects With Any Solicited Local and General Symptoms. Swelling	32 Participants
Number of Subjects With Any Solicited Local and General Symptoms. Fatigue	91 Participants
Number of Subjects With Any Solicited Local and General Symptoms. Gastrointestinal symptoms	33 Participants
Number of Subjects With Any Solicited Local and General Symptoms. Headache	76 Participants
Number of Subjects With Any Solicited Local and General Symptoms. Fever	16 Participants

SECONDARY outcome

Timeframe: Within 31 days (Day 0 - Day 30) after the vaccination.

Population: The analysis was based on the Total Vaccinated cohort, which included all subjects who received the study vaccine.

An unsolicited AE was defined as any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Outcome measures

Measure	Engerix-B Kinder Group n=302 Participants Subjects, who were previously primed and boosted with four doses of Infanrix hexa in the first two years of life, received a single challenge dose of Engerix-B Kinder.
Number of Subjects With Unsolicited Adverse Events (AEs)	55 Participants

SECONDARY outcome

Timeframe: From Day 0 to Day 30

Population: The analysis was based on the Total Vaccinated cohort, which included all subjects who received the study vaccine.

An SAE was defined as any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.

Outcome measures

Measure	Engerix-B Kinder Group n=302 Participants Subjects, who were previously primed and boosted with four doses of Infanrix hexa in the first two years of life, received a single challenge dose of Engerix-B Kinder.
Number of Subjects With Serious Adverse Events (SAEs)	2 Participants

Adverse Events

Engerix-B Kinder Group

Serious events: 2 serious events

Other events: 197 other events

Deaths: 0 deaths

Serious adverse events

Measure	Engerix-B Kinder Group n=302 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 challenge dose of Engerix-B Kinder.
Injury, poisoning and procedural complications Meniscus injury	0.33% 1/302 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-3) follow-up period after vaccination. Unsolicited AE(s) and SAE(s): during the entire study period (Days 0-30).
Psychiatric disorders Eating disorder	0.33% 1/302 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-3) follow-up period after vaccination. Unsolicited AE(s) and SAE(s): during the entire study period (Days 0-30).

Other adverse events

Measure	Engerix-B Kinder Group n=302 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 challenge dose of Engerix-B Kinder.
General disorders Fatigue	30.1% 91/302 • Number of events 91 • Solicited local and general symptoms: during the 4-day (Day 0-3) follow-up period after vaccination. Unsolicited AE(s) and SAE(s): during the entire study period (Days 0-30).
Gastrointestinal disorders Gastrointestinal disorder	10.9% 33/302 • Number of events 33 • Solicited local and general symptoms: during the 4-day (Day 0-3) follow-up period after vaccination. Unsolicited AE(s) and SAE(s): during the entire study period (Days 0-30).
Nervous system disorders Headache	26.2% 79/302 • Number of events 80 • Solicited local and general symptoms: during the 4-day (Day 0-3) follow-up period after vaccination. Unsolicited AE(s) and SAE(s): during the entire study period (Days 0-30).
General disorders Injection site erythema	21.5% 65/302 • Number of events 65 • Solicited local and general symptoms: during the 4-day (Day 0-3) follow-up period after vaccination. Unsolicited AE(s) and SAE(s): during the entire study period (Days 0-30).
General disorders Injection site pain	33.4% 101/302 • Number of events 101 • Solicited local and general symptoms: during the 4-day (Day 0-3) follow-up period after vaccination. Unsolicited AE(s) and SAE(s): during the entire study period (Days 0-30).
General disorders Injection site swelling	10.6% 32/302 • Number of events 32 • Solicited local and general symptoms: during the 4-day (Day 0-3) follow-up period after vaccination. Unsolicited AE(s) and SAE(s): during the entire study period (Days 0-30).
General disorders Pyrexia	5.3% 16/302 • Number of events 16 • Solicited local and general symptoms: during the 4-day (Day 0-3) follow-up period after vaccination. Unsolicited AE(s) and SAE(s): during the entire study period (Days 0-30).

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: eg763112@gsk.com

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