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:

A Phase III, Clinical Trial Comparing the Persistence of GSK Biologicals New Adjuvanted Hepatitis B Vaccine to a Double Dose of Engerix™-B at Months 24, 30, 36, in Pre-haemodialysis/Haemodialysis Patients (≥15 Years of Age)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00383591
• Other study ID #: 208129/047
• Status: Completed
• Phase: Phase 3
• First received: October 2, 2006
• Last updated: March 21, 2017
• Start date: March 2002
• Est. completion date: January 2004

Study information

• Verified date: March 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Persistence of anti-HBs antibodies at Month 24, 30 and 36 in subjects who had completed primary vaccination was evaluated. The anamnestic response to a booster dose was evaluated in subjects with anti-HBs antibody titres < 10 mIU/ml at previous timepoint. The study also evaluated the effect of a booster dose of the vaccine (Month 42) after primary vaccination.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• Subjects were to have completed primary vaccination course. 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.

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

Exclusion Criteria:

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

• Pregnant or lactating female.

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 Investigational Site	Hradec Kralove
Malaysia	GSK Investigational Site	Bandar Tun Razak, Cheras
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	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
Primary	Response to booster
Secondary	Solicited, unsolicited symptoms and serious adverse events