Trial Outcomes & Findings for Long-term Persistence of Immunity Against Hepatitis B in 7-8 Years Old Children After Hepatitis B Vaccination. (NCT NCT00519649)

NCT ID: NCT00519649

Last Updated: 2018-08-17

Results Overview

Anti-HBs antibody cut-off value assessed was 100 milli-international unit per milliliter (mIU/mL)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 301 participants
• Primary outcome timeframe: One month after the challenge dose of HBV vaccine
• Results posted on: 2018-08-17

Participant Flow

One additional subject, enrolled but not vaccinated, was not included in the number of subjects under "STARTED"

Participant milestones

Measure	Group Engerix Subjects received a single challenge dose of Engerix™ (hepatitis-B \[HBV\] vaccine)
Overall Study STARTED	300
Overall Study COMPLETED	299
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Group Engerix Subjects received a single challenge dose of Engerix™ (hepatitis-B \[HBV\] vaccine)
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Long-term Persistence of Immunity Against Hepatitis B in 7-8 Years Old Children After Hepatitis B Vaccination.

Baseline characteristics by cohort

Measure	Group Engerix n=300 Participants Subjects received a single challenge dose of Engerix™ (hepatitis-B \[HBV\] vaccine)
Age, Continuous	7.7 years STANDARD_DEVIATION 0.46 • n=5 Participants
Sex: Female, Male Female	136 Participants n=5 Participants
Sex: Female, Male Male	164 Participants n=5 Participants

PRIMARY outcome

Timeframe: One month after the challenge dose of HBV vaccine

Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity

Anti-HBs antibody cut-off value assessed was 100 milli-international unit per milliliter (mIU/mL)

Outcome measures

Measure	Group Engerix n=280 Participants Subjects received a single challenge dose of Engerix™ (hepatitis-B \[HBV\] vaccine)
Number of Participants With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-off Value	275 Participants

SECONDARY outcome

Timeframe: Before challenge dose of HBV vaccine

Population: Analysis was performed on subjects from the According-to-Protocol cohort for analysis of antibody persistence for whom serological results were available at pre-HBV vaccine challenge blood sampling time point

Anti-HBs antibody cut-off values assessed include 3.3, 10 and 100 mIU/mL

Outcome measures

Measure	Group Engerix n=282 Participants Subjects received a single challenge dose of Engerix™ (hepatitis-B \[HBV\] vaccine)
Number of Participants With Anti-HBs Antibody Concentrations Above the Cut-off Value >= 100 mIU/mL	104 Participants
Number of Participants With Anti-HBs Antibody Concentrations Above the Cut-off Value >= 3.3 mIU/mL	261 Participants
Number of Participants With Anti-HBs Antibody Concentrations Above the Cut-off Value >= 10 mIU/mL	235 Participants

SECONDARY outcome

Timeframe: During the 4-day follow-up period after the challenge dose of HBV vaccine.

Solicited local symptoms assessed include pain, redness and swelling

Outcome measures

Measure	Group Engerix n=299 Participants Subjects received a single challenge dose of Engerix™ (hepatitis-B \[HBV\] vaccine)
Number of Participants Reporting Solicited Local Symptoms Pain	89 Participants
Number of Participants Reporting Solicited Local Symptoms Redness	81 Participants
Number of Participants Reporting Solicited Local Symptoms Swelling	42 Participants

SECONDARY outcome

Timeframe: During the 4-day follow-up period after the challenge dose of HBV vaccine.

Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms, and headache

Outcome measures

Measure	Group Engerix n=299 Participants Subjects received a single challenge dose of Engerix™ (hepatitis-B \[HBV\] vaccine)
Number of Participants Reporting Solicited General Symptoms Fatigue	44 Participants
Number of Participants Reporting Solicited General Symptoms Fever (Axillary)	9 Participants
Number of Participants Reporting Solicited General Symptoms Gastrointestinal	23 Participants
Number of Participants Reporting Solicited General Symptoms Headache	40 Participants

SECONDARY outcome

Timeframe: During the 31-day follow-up period after the challenge dose of HBV vaccine.

An Adverse Event is 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.

Outcome measures

Measure	Group Engerix n=300 Participants Subjects received a single challenge dose of Engerix™ (hepatitis-B \[HBV\] vaccine)
Number of Participants Reporting Unsolicited Adverse Events	71 Participants

SECONDARY outcome

Timeframe: After the challenge dose of HBV vaccine.

An SAE is any untoward medical occurrence that:

results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.

Outcome measures

Measure	Group Engerix n=300 Participants Subjects received a single challenge dose of Engerix™ (hepatitis-B \[HBV\] vaccine)
Number of Participants Reporting Serious Adverse Events (SAE)	1 Participants

Adverse Events

Group Engerix

Serious events: 1 serious events

Other events: 159 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group Engerix n=300 participants at risk Subjects received a single challenge dose of Engerix™ (hepatitis-B \[HBV\] vaccine)
Injury, poisoning and procedural complications Concussion	0.33% 1/300

Other adverse events

Measure	Group Engerix n=300 participants at risk Subjects received a single challenge dose of Engerix™ (hepatitis-B \[HBV\] vaccine)
General disorders Pain	29.7% 89/300
General disorders Redness	27.0% 81/300
General disorders Swelling	14.0% 42/300
General disorders Fatigue	14.7% 44/300
General disorders Gastrointestinal	7.7% 23/300
General disorders Headache	13.3% 40/300

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