NCT01138098

Evaluation of Antibody Persistence and Immune Memory Against the Hepatitis B Antigen in Previously Vaccinated Children

Completed Phase 4 Results posted Last updated 20 August 2018

What this trial tests

Phase 4 trial testing Engerix™-B in Hepatitis B in 185 participants. Completed in 26 November 2010.

Timeline

7 June 2010

Primary endpoint
26 November 2010

26 November 2010

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	185
Start date	7 June 2010
Primary completion	26 November 2010
Estimated completion	26 November 2010
Sites	11 locations across Slovakia

Drugs / interventions tested

• Engerix™-B

Conditions studied

• Hepatitis B — all drugs for Hepatitis B →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 11 to 12, any sex, with Hepatitis B. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 100 Milli-International Units Per Milliliter (mIU/mL) Primary · One month after a challenge dose of Engerix-B vaccine

A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.

Group	Value	95% CI
Infanrix-hexa/Engerix-B Group	88
Infanrix-IPV+Hib/Engerix-B Group	84

Number of Subjects With an Anamnestic Response to a Challenge Dose Secondary · Before and one month after a challenge dose of Engerix-B vaccine

The anamnestic response was defined as: at least (≥) a 4-fold rise in post-challenge dose anti-HBs antibody concentrations in subjects seropositive at the pre-challenge dose time point. - Post-challenge dose anti-HBs antibody concentrations ≥ 10 mIU/mL in seronegative subjects at the pre-challenge dose time point. A seropositive/seronegative subject is a subject with anti-HBs antibody concentration ≥/lower than (\<) 6.2 mIU/mL. A decrease in the specificity of the anti-HB ELISA had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initial

Group	Value	95% CI
Infanrix-hexa/Engerix-B Group	91
Infanrix-IPV+Hib/Engerix-B Group	86

Number of Subjects With Anti-HBs Antibody Concentration ≥ 6.2 mIU/mL Secondary · Before and one month after a challenge dose of Engerix-B vaccine

A seropositive subject was defined as a subject with anti-HBs antibody concentration ≥ the 6.2 mIU/mLcut-off. A decrease in the specificity of the anti-HB ELISA had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis and the initial 3.3 mIU/mL seropositivity cut-off was revised into the new 6.2 mIU/mL cut-off.

≥ 6.2 mIU/mL [pre-challenge dose]

Group	Value	95% CI
Infanrix-hexa/Engerix-B Group	53
Infanrix-IPV+Hib/Engerix-B Group	57

≥ 6.2 mIU/mL [post-challenge dose]

Group	Value	95% CI
Infanrix-hexa/Engerix-B Group	92
Infanrix-IPV+Hib/Engerix-B Group	88

Number of Subjects With Anti-HBs Antibody Concentration ≥ 10 mIU/mL Secondary · Before and one month after a challenge dose of Engerix-B vaccine

A seroprotected subject was defined as a subject with anti-HBs antibody concentration ≥ 10 mIU/mL. A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.

≥ 10 mIU/mL [pre-challenge dose]

Group	Value	95% CI
Infanrix-hexa/Engerix-B Group	46
Infanrix-IPV+Hib/Engerix-B Group	52

≥ 10 mIU/mL [post-challenge dose]

Group	Value	95% CI
Infanrix-hexa/Engerix-B Group	91
Infanrix-IPV+Hib/Engerix-B Group	88

Number of Subjects With Anti-HBs Antibody Concentration ≥ 100 mIU/mL Secondary · Before the challenge dose of Engerix-B vaccine

A seroprotected subject was defined as a subject with anti-HBs antibody concentration ≥ 10 mIU/mL. A decrease in the specificity of the anti-HB ELISA had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.

Group	Value	95% CI
Infanrix-hexa/Engerix-B Group	14
Infanrix-IPV+Hib/Engerix-B Group	17

Number of Subjects Reporting Solicited Local Symptoms Secondary · During the 4-day (Days 0-3) follow-up period after a challenge dose of Engerix-B vaccine

Solicited local symptoms assessed were pain, redness and swelling.

Pain

Group	Value	95% CI
Infanrix-hexa/Engerix-B Group	30
Infanrix-IPV+Hib/Engerix-B Group	24

Redness

Group	Value	95% CI
Infanrix-hexa/Engerix-B Group	25
Infanrix-IPV+Hib/Engerix-B Group	22

Swelling

Group	Value	95% CI
Infanrix-hexa/Engerix-B Group	15
Infanrix-IPV+Hib/Engerix-B Group	8

Number of Subjects Reporting Solicited General Symptoms Secondary · During the 4-day (Days 0-3) follow-up period after a challenge dose of Engerix-B vaccine

Solicited general symptoms assessed were fatigue, gastrointestinal, headache and temperature (Temperature is defined as axillary temparature equal to or above 37.5 degrees Celsius (°C)).

Fatigue

Group	Value	95% CI
Infanrix-hexa/Engerix-B Group	23
Infanrix-IPV+Hib/Engerix-B Group	22

Gastrointestinal

Group	Value	95% CI
Infanrix-hexa/Engerix-B Group	9
Infanrix-IPV+Hib/Engerix-B Group	9

Headache

Group	Value	95% CI
Infanrix-hexa/Engerix-B Group	19
Infanrix-IPV+Hib/Engerix-B Group	14

Temperature ≥ 37.5°C

Group	Value	95% CI
Infanrix-hexa/Engerix-B Group	1
Infanrix-IPV+Hib/Engerix-B Group	3

Number of Subjects Reporting Unsolicited Adverse Events (AEs) Secondary · During the 31-day (Days 0-30) follow-up period after a challenge dose of Engerix-B vaccine

An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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.

Group	Value	95% CI
Infanrix-hexa/Engerix-B Group	5
Infanrix-IPV+Hib/Engerix-B Group	7

Number of Subjects Reporting Serious Adverse Events (SAEs) Secondary · After the challenge dose of Engerix-B vaccine up to the study end

SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.

Group	Value	95% CI
Infanrix-hexa/Engerix-B Group	1
Infanrix-IPV+Hib/Engerix-B Group	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Solicited symptoms: During the 4-day (Days 0-3) follow-up period after the challenge dose of Engerix-B vaccine. SAEs: after the challenge dose of Engerix-B vaccine up to the study end. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Infanrix-hexa/Engerix-B Group

Serious: 1/95 (1%)

Deaths: 0/95

Infanrix-IPV+Hib/Engerix-B Group

Serious: 0/90 (0%)

Deaths: 0/90

Serious adverse events (1 terms)

Reaction	System	Infanrix-hexa/Engerix-B Gr…	Infanrix-IPV+Hib/Engerix-B…
Infection	Infections and infestations	—	—

Other adverse events (6 terms — click to expand)

Reaction	System	Infanrix-hexa/Engerix-B Gr…	Infanrix-IPV+Hib/Engerix-B…
Pain	General disorders	—	—
Redness	General disorders	—	—
Fatigue	General disorders	—	—
Headache	General disorders	—	—
Swelling	General disorders	—	—
Gastrointestinal	General disorders	—	—

Most-reported serious reactions: Infection.

Data from ClinicalTrials.gov NCT01138098 adverse events section.

Sponsor's own description

This study will evaluate the persistence of immunity to hepatitis B 10 to 11 years after vaccination with Infanrix hexa™ or Engerix™-B and also the ability to mount an immune response to the challenge dose of Engerix™-B.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.