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

Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00697970
• Other study ID #: 208129/006
• Status: Completed
• Phase: Phase 3
• First received: June 12, 2008
• Last updated: June 13, 2008
• Start date: November 1993
• Est. completion date: April 1995

Study information

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

Clinical Trial 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

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: 321
• Est. completion date: April 1995
• Est. primary completion date: April 1995
• 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.

• 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

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

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