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

Study to Evaluate the Immunogenicity and Reactogenicity of Various Formulations of GSK Biologicals' (Previously SmithKline Beecham Biologicals') Recombinant Hepatitis B Vaccine in Healthy Adult Volunteers

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00697970

Enrollment

321

Registered

2008-06-16

Start date

1993-11-30

Completion date

1995-04-30

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 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

Detailed description

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

Interventions

BIOLOGICALHBsAg formulated with different concentrations of MPL and Aluminium Salts

Intramuscular injection, 3 doses

BIOLOGICALEngerix™-B

Intramuscular injection, 3 doses

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. * 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

Design outcomes

Primary

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

Secondary

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

Countries

Austria

Outcome results

None listed

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