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

NCT00383227 | Completed Phase 3

• 1 other identifier: 208129/032
• Study Type: interventional
• Target: 165
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hepatitis B

Outcome Measures

Primary Outcomes (1)

• Anti-HBs seroprotection rates at Month 7.

Secondary Outcomes (1)

• Solicited symptoms, unsolicited symptoms and serious adverse events

Interventions

Hepatitis B adjuvanted vaccine BIOLOGICAL

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• GlaxoSmithKline: lead

Related Publications (3)

• Kong NC, Beran J, Kee SA, Miguel JL, Sanchez C, Bayas JM, Vilella A, Calbo-Torrecillas F, Lopez 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. doi: 10.1038/sj.ki.5002725. Epub 2007 Dec 26.

  PMID: 18160963 BACKGROUND

• Tong NK, Beran J, Kee SA, Miguel JL, Sanchez 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. doi: 10.1111/j.1523-1755.2005.00689.x.

  PMID: 16221232 BACKGROUND

• 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.

  PMID: 18845199 BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2006
• First Posted: October 3, 2006
• Study Start: December 1, 1999
• Primary Completion: November 1, 2000
• Study Completion: November 1, 2000
• Last Updated: September 16, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share