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

Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00697840
• Other study ID #: 208129/019
• Status: Completed
• Phase: Phase 3
• First received: June 12, 2008
• Last updated: June 13, 2008
• Start date: June 1995
• Est. completion date: January 1996

Study information

• Verified date: June 2008
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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

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: 150
• Est. completion date: January 1996
• Est. primary completion date: January 1996
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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.

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, 2 doses
• HBV-MPL 208129
Intramuscular injection, 2 doses
• Vaccine containing HBsAg absorbed on aluminium salts - experimental formulation
Intramuscular injection, 2 doses; experimental formulation

Locations

Country	Name	City	State
Austria	GSK Clinical Trials Call Center	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Austria, 

Outcome

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