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

Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00697242
• Other study ID #: 208129/009
• Status: Completed
• Phase: Phase 3
• First received: June 11, 2008
• Last updated: June 11, 2008
• Start date: January 1994
• Est. completion date: November 1995

Study information

• Verified date: June 2008
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review BoardDenmark: National Board of HealthAustria: EthikkommissionIreland: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 362
• Est. completion date: November 1995
• Est. primary completion date: November 1995
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

Biological:
• Engerix™-B
Intramuscular injection, 3 doses
• Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL
Intramuscular injection, 3 doses

Locations

Country	Name	City	State
Austria	GSK Clinical Trials Call Center	Wien
Belgium	GSK Clinical Trials Call Center	Gent
Denmark	GSK Clinical Trials Call Center	Hvidovre
Iceland	GSK Clinical Trials Call Center	Reykjavik

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Austria,  Belgium,  Denmark,  Iceland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-hepatitis B surface antigen (HBs) antibody concentrations		At M2 and M7
Secondary	Anti-pre-S1 antibody concentrations		Screening, Months 1, 2, 3, 6, 7, 8 and 12, depending on group allocation
Secondary	Anti-HBs antibody concentrations		Screening, Months 1, 2, 3, 6, 7, 8 and 12
Secondary	Occurrence and intensity of local and general solicited symptoms		4-day after vaccination
Secondary	Cell mediated immunity		Month 0, Month 2 and month 7
Secondary	Occurrence of unsolicited adverse events		30 days after vaccination
Secondary	Occurrence of serious adverse events		During the study period and 30 days after last vaccine dose