Comparison of Immuno, Reacto and Safety of Recombinant Hepatitis B Vaccine With or Without MPL in Healthy Older Adults

Study to Compare the Immunogenicity, Safety and Reactogenicity of GSK Biologicals' (Previously SmithKline Beecham Biologicals') Recombinant Hepatitis B Vaccines With and Without Adjuvant in Healthy Older Adult Volunteers

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00697242

Enrollment

362

Registered

2008-06-13

Start date

1994-01-31

Completion date

1995-11-30

Last updated

2008-06-13

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

Brief summary

In the present study the immunogenicity, reactogenicity and safety of recombinant hepatitis B vaccines with and without MPL will be evaluated in older healthy subjects

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, 3 doses

BIOLOGICALRecombinant HBsAg with different concentrations of Aluminium Salts and/or MPL

Intramuscular injection, 3 doses

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

50 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male or female subjects between 50 and 70 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

Exclusion criteria

* Positive titres for anti hepatitis antibodies * Any vaccination against hepatitis B in the past. * Any previous administration of MPL * Elevated serum liver enzymes at two subsequent determinations 14 days apart. * 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-hepatitis B surface antigen (HBs) antibody concentrations	At M2 and M7

Secondary

Measure	Time frame
Anti-HBs antibody concentrations	Screening, Months 1, 2, 3, 6, 7, 8 and 12
Occurrence and intensity of local and general solicited symptoms	4-day after vaccination
Anti-pre-S1 antibody concentrations	Screening, Months 1, 2, 3, 6, 7, 8 and 12, depending on group allocation
Occurrence of unsolicited adverse events	30 days after vaccination
Occurrence of serious adverse events	During the study period and 30 days after last vaccine dose
Cell mediated immunity	Month 0, Month 2 and month 7

Countries

Austria, Belgium, Denmark, Iceland

Outcome results

None listed

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