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 Immunogenicity and Safety of SmithKline Beecham 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: NCT00383227
• Other study ID #: 208129/032
• Status: Completed
• Phase: Phase 3
• First received: October 2, 2006
• Last updated: September 15, 2016
• Start date: December 1999
• Est. completion date: November 2000

Study information

• Verified date: September 2016
• 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: 165
• Est. completion date: November 2000
• Est. primary completion date: November 2000
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

References & Publications (3)

Kong NC, Beran J, Kee SA, Miguel JL, Sánchez C, Bayas JM, Vilella A, Calbo-Torrecillas F, López de Novales E, Srinivasa K, Stoffel M, Hoet B. A new adjuvant improves the immune response to hepatitis B vaccine in hemodialysis patients. Kidney Int. 2008 Apr;73(7):856-62. Epub 2007 Dec 26. — View Citation

Tong NK, Beran J, Kee SA, Miguel JL, Sánchez C, Bayas JM, Vilella A, de Juanes JR, Arrazola P, Calbo-Torrecillas F, de Novales EL, Hamtiaux V, Lievens M, Stoffel M. Immunogenicity and safety of an adjuvanted hepatitis B vaccine in pre-hemodialysis and hemodialysis patients. Kidney Int. 2005 Nov;68(5):2298-303. — View Citation

Verstraeten T, Descamps D, David MP, Zahaf T, Hardt K, Izurieta P, Dubin G, Breuer T. Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 2008 Dec 2;26(51):6630-8. doi: 10.1016/j.vaccine.2008.09.049. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-HBs seroprotection rates at Month 7.			No
Secondary	Solicited symptoms, unsolicited symptoms and serious adverse events			No

External Links

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