Safety and Immunogenicity of 3 Lots of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Volunteers ≥ 15y

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00696917
First received: June 11, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted
  Purpose

This study was conducted to evaluate the lot-to-lot consistency of three lots of HBV-MPL vaccine and to compare their safety and immunogenicity with that of Engerix™-B.


Condition Intervention Phase
Hepatitis B
Biological: HBV-MPL vaccine 208129
Biological: Engerix™-B
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of 3 Lots of GSK Biologicals' Novel Adjuvanted Hepatitis B Vaccine, Administered According to a 2 Dose Schedule, and Engerix™-B Administered According to a 3 Dose Schedule to Healthy Volunteers ≥ 15 Years of Age

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence, intensity and causal relationship of any (solicited/unsolicited adverse event) general symptoms [ Time Frame: Full course of vaccination ]
  • Incidence of serious adverse events [ Time Frame: Study period ]
  • Anti-HBs antibody concentrations [ Time Frame: At Month 7 ]

Secondary Outcome Measures:
  • Occurrence and intensity of solicited local signs and symptoms [ Time Frame: 4-day after vaccination ]
  • Occurrence, intensity and relationship to vaccination of solicited general signs and symptoms [ Time Frame: 4-day after vaccination ]
  • Occurrence, intensity and relationship to vaccination of unsolicited signs and symptoms [ Time Frame: 30 days after vaccination ]
  • Occurrence and relationship to vaccination of SAEs [ Time Frame: During the study period ]
  • Anti-HBs antibody concentrations [ Time Frame: At Months 1, 2, 6 and 7 ]

Enrollment: 1303
Study Start Date: April 1999
Primary Completion Date: February 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group A
Three doses according to 0, 1, 6-month schedule
Biological: Engerix™-B
3-dose intramuscular injection
Experimental: Group B
Two doses according to 0, 6-month schedule, with a placebo injection at Month 1
Biological: HBV-MPL vaccine 208129
2-dose intramuscular injection 3 different vaccine lots
Experimental: Group C
Two doses according to 0, 6-month schedule, with a placebo injection at Month 1
Biological: HBV-MPL vaccine 208129
2-dose intramuscular injection 3 different vaccine lots
Experimental: Group D
Two doses according to 0, 6-month schedule, with a placebo injection at Month 1
Biological: HBV-MPL vaccine 208129
2-dose intramuscular injection 3 different vaccine lots

Detailed Description:

At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A male or female aged ≥ 15 years at the time of the first vaccination. In Centre 103 (Germany) and Centre 1 (Netherlands), only subjects ≥ 18 years will be enrolled.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
  • Written informed consent obtained from the subject and/or from the parent or guardian of the subject.
  • If the subject was a female, she was of non-childbearing potential, if of childbearing potential, she was abstinent or used 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 (s) during the study period or within 30 days preceding the first dose of study vaccine.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine and ending 30 days after.
  • Previous vaccination against hepatitis B.
  • History of non-response to previous hepatitis B vaccination.
  • Known exposure to hepatitis B within the past 6 weeks.
  • History of hepatitis B infection.
  • Confirmed human immunodeficiency virus (HIV) infection.
  • A family history of congenital or hereditary immunodeficiency.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Acute disease at the time of enrollment.
  • Hepatomegaly, right upper quadrant abdominal pain or tenderness.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration/ administration during the study period.
  • Pregnant or lactating female
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00696917

Locations
Australia, Victoria
GSK Clinical Trials Call Center
Parkville, Victoria, Australia, 3052
Czech Republic
GSK Clinical Trials Call Center
Hradec Kralové, Czech Republic
Germany
GSK Clinical Trials Call Center
München, Germany
Italy
GSK Clinical Trials Call Center
Bari, Italy
Netherlands
GSK Clinical Trials Call Center
Utrecht, Netherlands
Switzerland
GSK Clinical Trials Call Center
Lausanne, Switzerland
United Kingdom
GSK Clinical Trials Call Center
London, United Kingdom
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Isabelle Harpigny, GSK
ClinicalTrials.gov Identifier: NCT00696917     History of Changes
Other Study ID Numbers: 208129/031
Study First Received: June 11, 2008
Last Updated: June 11, 2008
Health Authority: Czech Republic: State Institute for Drug Control

Keywords provided by GlaxoSmithKline:
Hepatitis B
Adjuvanted Hepatitis B vaccine
Recombinant Hepatitis B vaccine

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on July 26, 2014