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Completed

NCT Number: NCT00383591

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

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.

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Key information

Conditions

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

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Hradec Králové, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hepatitis B adjuvanted vaccine

Biological

Engerix-B

Biological

Other names: Hepatitis B adjuvanted vaccine

Primary outcomes

  1. Anti-HBs seroprotection

  2. Response to booster

Secondary outcomes

  1. Solicited, unsolicited symptoms and serious adverse events

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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)

Important dates

Study start
2002
Study completion
2004
First posted
Oct 3, 2006
Registry last updated
Mar 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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