Safety, Immunogenicity and Reactogenicity of Recombinant Hepatitis B Vaccine (Adjuvanted & New Formulation) and Engerix™-B

Study to Assess the Safety, Immunogenicity and Reactogenicity of GSK Biologicals' (Previously SmithKline Beecham Biologicals') Adjuvanted Recombinant Hepatitis B Vaccine, Recombinant Hepatitis B Vaccine New Formulation and Engerix™-B

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00697840

Enrollment

150

Registered

2008-06-16

Start date

1995-06-30

Completion date

1996-01-31

Last updated

2008-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B

Keywords

Hepatitis B, Engerix™-B, Recombinant hepatitis B vaccine, Adjuvant

Brief summary

The purpose of the present trial is to assess the safety, reactogenicity and immunogenicity of adjuvanted hepatitis B vaccine, Engerix™-B and hepatitis B vaccine new formulation when administered at 0, 6 months

Detailed description

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

Interventions

BIOLOGICALEngerix™-B

Intramuscular injection, 2 doses

BIOLOGICALHBV-MPL 208129

Intramuscular injection, 2 doses

BIOLOGICALVaccine containing HBsAg absorbed on aluminium salts - experimental formulation

Intramuscular injection, 2 doses; experimental formulation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

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

* Pregnancy or lactation. * Positive titres for anti HBs antibody. * 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. * Simultaneous administration of any other vaccine(s). * Administration of any immunoglobulin during the study period. * Simultaneous participation in any other clinical trial.

Design outcomes

Primary

Measure	Time frame
Anti-HBs antibody concentrations	At month 7
Occurrence and intensity of solicited local and general symptoms	4-day follow-up after vaccination
Occurrence of unsolicited adverse events	30-days after vaccination
Incidence of serious adverse events	Throughout the study period
Anti-Hbs antibody concentrations	Months 1, 6 and 24

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026