Immunogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Adults (15-40 Yrs).

Hepatitis B Clinical Trial

Official title:

Study Comparing the Immunogenicity and Reactogenicity of GSK Biologicals' HBV-MPL Vaccine Injected According to a 0, 6 Months Schedule With That of Engerix™-B Injected as a 0, 1, 6 Months Schedule in a Healthy Adult Population (15-40 Years)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00697216
• Other study ID #: 208129/027
• Status: Completed
• Phase: Phase 3
• First received: June 11, 2008
• Last updated: June 11, 2008
• Start date: March 1997

Study information

• Verified date: June 2008
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ministry of Social Affairs, Public Health and the Environment
• Study type: Interventional

Clinical Trial Summary

This study evaluates the safety and immunogenicity of the candidate HBV-MPL vaccine administered to healthy adults aged from 15 to 40 years, according to a 0, 6- month vaccination schedule, with Engerix™-B as control administered at 0, 1, 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: 340
• Est. primary completion date: March 1999
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 40 Years

Eligibility

Inclusion Criteria:

• Age: between 15 and 40 years old.

• Good physical condition as established by clinical examination and history taking at the time of entry.

• Female participants who are at risk to become pregnant will be on a contraceptive programme if necessary during the study period.

• Written informed consent obtained from the subjects aged between 18 and 40 and from the parents/tutor when the subjects are aged between 15 and 17 years.

Exclusion Criteria:

• Positive titres at screening for anti-HBs antibodies.

• Elevated serum liver enzymes.

• History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.

• Any acute disease at the moment of entry.

• Chronic alcohol consumption.

• Hepatomegaly, right upper quadrant abdominal pain or tenderness.

• Any chronic drug treatment, including any treatment with immunosuppressive drugs, 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 participation in any other clinical trial.

• Previous vaccination with a hepatitis B vaccine.

• Previous vaccination with an MPL containing vaccine.

• Administration of immunoglobulins in the past 6 months and during the whole study period

• Simultaneous vaccination one week before and one week after each dose of the study vaccine

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis B

Intervention

Biological:
• HBV-MPL vaccine 208129
2-dose intramuscular injection
• Engerix™-B
3-dose intramuscular injection

Locations

Country	Name	City	State
Belgium	GSK Clinical Trials Call Center	Brussels
Denmark	GSK Clinical Trials Call Center	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Belgium,  Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-HBs antibody concentrations		Month 7
Secondary	Anti-HBs antibody concentrations		At months 1, 2, 6, 7 and 12
Secondary	Occurrence, intensity and relationship to vaccination of solicited local and general symptoms		4-day follow-up period after vaccination
Secondary	Occurrence, intensity and relationship to vaccination of unsolicited symptoms		31-day follow-up after vaccination
Secondary	Occurrence and relationship to vaccination of Serious Adverse Events (SAEs)		During the study period