CompletedNCT00697970Updated Jun 16, 2008

Evaluation of Immunogenicity and Reactogenicity of Various Formulations of Recombinant Hepatitis B Vaccine

A Phase 3 interventional study of HBsAg formulated with different concentrations of MPL and Aluminium Salts and Engerix™-B in Hepatitis B, sponsored by GlaxoSmithKline. Completed at 1 site in Austria. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-06-16.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention

Phase: Phase 3
Study type: Interventional
Enrollment: 321
Allocation: Randomized
Ages: 18 Years to 40 Years
Sex: All

Study summary

The purpose of the present trial is to evaluate 6 vaccine formulations of recombinant hepatitis B vaccine for their reactogenicity and immunogenicity when administered at 0-2 months with a booster at month 12

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At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

Conditions studied

Hepatitis B

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Keywords

Hepatitis B
Engerix™-B
Recombinant Hepatitis B vaccine
Adjuvant

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 321 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 40 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Between 18 and 40 years old.
Written informed consent will have been obtained from the subjects.
Good physical condition as established by physical examination and history taking at the time of entry.
Female participants will avoid becoming pregnant during the study period and they will have been on a contraceptive program for at least 2 months before entry.

Exclusion criteria

Exclusion Criteria:

Pregnancy or lactation.
Positivity for anti hepatitis antibodies.
Any vaccination against hepatitis B in the past.
Any previous administration of MPL.
Elevated serum liver enzymes.
History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
Axillary temperature > 37.5°C at the time of injection.
Any acute disease at the moment of entry.
Chronic alcohol consumption.
Any treatment with immunosuppressive or immunostimulant therapy.
Any chronic drug treatment, which in the investigator's opinion, precludes inclusion into the study.
History of allergic disease likely to be stimulated by any component of the vaccine.
Administration of any other vaccine(s) or any immunoglobulin during the study period.
Simultaneous participation in any other clinical trial

Study design

Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 321 participants (actual)

Study arms

Experimental
Group A
Biological: HBsAg formulated with different concentrations of MPL and Aluminium Salts
Experimental
Group B
Biological: HBsAg formulated with different concentrations of MPL and Aluminium Salts
Experimental
Group C
Biological: HBsAg formulated with different concentrations of MPL and Aluminium Salts
Experimental
Group D
Biological: HBsAg formulated with different concentrations of MPL and Aluminium Salts
Experimental
Group E
Biological: HBsAg formulated with different concentrations of MPL and Aluminium Salts
Active comparator
Group F
Biological: Engerix™-B

Interventions

BiologicalHBsAg formulated with different concentrations of MPL and Aluminium Salts
Intramuscular injection, 3 doses
BiologicalEngerix™-B
Intramuscular injection, 3 doses

What researchers measure

Primary outcomes

Anti-HBs antibody concentrations
Time frame: After two doses and after the booster dose

Secondary outcomes

Occurrence and intensity of local and general solicited symptoms
Time frame: 8 days after vaccination
Anti-HBs antibody concentrations
Time frame: Screening, M1, 2, 3, 4, 6, 12, 13
Occurrence of unsolicited adverse events
Time frame: 30-day after vaccination
Occurrence of serious adverse events
Time frame: During the study period and 30 days after the last vaccination

Study locations

1 site

GSK Clinical Trials Call Center
Vienna, Austria

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 16, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00697970
Lead sponsor: GlaxoSmithKline
First posted: Jun 16, 2008
Start date: Nov 1993
Primary completion: Apr 1995
Completion: Apr 1995
Last update: Jun 16, 2008

Study contacts

Clinical Trials

study director · GlaxoSmithKline

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.

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