Comparison of Adjuvanted Hepatitis B Vaccine to Double Dose of Engerix™-B in Pre- /Haemodialysis Patients Aged ≥15 Years

Hepatitis B Clinical Trial

Official title:

To Compare the Immunogenicity & Safety of GSK Biologicals New Adjuvanted Hepatitis B Vaccine to a Double Dose of Engerix™-B, in Pre-Haemodialysis/Haemodialysis Patients (≥15 Years of Age)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00383383
• Other study ID #: 208129/042
• Status: Completed
• Phase: Phase 3
• First received: October 2, 2006
• Last updated: October 2, 2006
• Start date: December 1999

Study information

• Verified date: October 2006
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial Summary

Comparison of adjuvanted hepatitis B vaccine to double dose of Engerix™-B in pre- /haemodialysis patients aged ≥15 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• A male or female > = 15 years of age at the time of the first vaccination.

• Written informed consent obtained from the subject/ from the parents or guardians of the subject.

• Seronegative for anti-HBs antibodies, anti-HBc antibodies & Hepatitis B Surface antigen (HBsAg).

• If the subject was a female, she was of non-childbearing potential or, if of childbearing potential, she had to be abstinent or use adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination.

• Pre-haemodialysis patient* or a patient on haemodialysis.

Exclusion Criteria:

• Use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period or within 30 days preceding the first dose of study vaccine.

• Previous vaccination against hepatitis B.

• History of hepatitis B infection.

• Known exposure to hepatitis B virus within 6 weeks. Pregnant or lactating female

• Clinically abnormal ALT/AST values (> 3 times normal values)

Study Design

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

Biological:
• Hepatitis B adjuvanted vaccine

• Engerix-B

Locations

Country	Name	City	State
Czech Republic	GSK Clinical Trials Call Center	Hradec	Králové
Malaysia	GSK Clinical Trials Call Center	Kuala Lumpur
Spain	GSK Clinical Trials Call Center	Malaga

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Czech Republic,  Malaysia,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-HBs seroprotection rates at Month 12.
Secondary	Solicited symptoms, unsolicited symptoms and serious adverse events