Trial Outcomes & Findings for Immune Response to Hepatitis B Vaccine Challenge Dose in Subjects Who Received a Primary Neonatal Hepatitis B Vaccine. (NCT NCT00456625)

Results Overview

The cut-off values assessed include: ≥ 3.3 Milli International Units per Milliliter (mIU/mL), ≥ 10 mIU/mL, and ≥ 100 mIU/mL.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

76 participants

Primary outcome timeframe

One month after the hepatitis B vaccine challenge dose

Results posted on

2016-12-16

Participant Flow

Participant milestones

Participant milestones
Measure	Group Engerix™-B Subjects received a dose of Hepatitis B vaccine approximately 20 years after the primary neonatal vaccination
Overall Study STARTED	76
Overall Study COMPLETED	76
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Immune Response to Hepatitis B Vaccine Challenge Dose in Subjects Who Received a Primary Neonatal Hepatitis B Vaccine.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group Engerix™-B n=76 Participants Subjects received a dose of Hepatitis B vaccine approximately 20 years after the primary neonatal vaccination
Age, Continuous	19.9 years STANDARD_DEVIATION 0.59 • n=5 Participants
Gender Female	36 Participants n=5 Participants
Gender Male	40 Participants n=5 Participants

PRIMARY outcome

Timeframe: One month after the hepatitis B vaccine challenge dose

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (including all evaluable subjects who had received the challenge dose of hepatitis B vaccine and for whom immunogenicity data were available at the post-hepatitis B vaccine challenge dose timepoint).

The cut-off values assessed include: ≥ 3.3 Milli International Units per Milliliter (mIU/mL), ≥ 10 mIU/mL, and ≥ 100 mIU/mL.

Outcome measures

Outcome measures
Measure	Group Engerix™-B n=72 Participants Subjects received a dose of Hepatitis B vaccine approximately 20 years after the primary neonatal vaccination
Number of Participants With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Specific Cut-off Values ≥ 3.3 mIU/mL	72 participants
Number of Participants With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Specific Cut-off Values ≥ 10 mIU/mL	71 participants
Number of Participants With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Specific Cut-off Values ≥ 100 mIU/mL	64 participants

SECONDARY outcome

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

An AE 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. An AE is considered severe if it prevents normal, everyday activities.

Outcome measures

Outcome measures
Measure	Group Engerix™-B n=76 Participants Subjects received a dose of Hepatitis B vaccine approximately 20 years after the primary neonatal vaccination
Occurrence, Intensity and Relationship to Vaccination of Unsolicited Adverse Events (AEs) Any AEs	1 participants
Occurrence, Intensity and Relationship to Vaccination of Unsolicited Adverse Events (AEs) Severe AEs	0 participants
Occurrence, Intensity and Relationship to Vaccination of Unsolicited Adverse Events (AEs) Related AEs	0 participants

SECONDARY outcome

Timeframe: Up to 1 month after the challenge dose.

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

Outcome measures
Measure	Group Engerix™-B n=76 Participants Subjects received a dose of Hepatitis B vaccine approximately 20 years after the primary neonatal vaccination
Number of Participants Reporting Any Serious Adverse Events (SAEs).	0 participants

Adverse Events

Group Engerix™-B

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

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