Hepatitis B Clinical Trial
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
NCT number | NCT00696917 |
Other study ID # | 208129/031 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | June 11, 2008 |
Last updated | June 11, 2008 |
Start date | April 1999 |
Verified date | June 2008 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | Czech Republic: State Institute for Drug Control |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1303 |
Est. completion date | |
Est. primary completion date | February 2000 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 15 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Australia | GSK Clinical Trials Call Center | Parkville | Victoria |
Czech Republic | GSK Clinical Trials Call Center | Hradec Kralové | |
Germany | GSK Clinical Trials Call Center | München | |
Italy | GSK Clinical Trials Call Center | Bari | |
Netherlands | GSK Clinical Trials Call Center | Utrecht | |
Switzerland | GSK Clinical Trials Call Center | Lausanne | |
United Kingdom | GSK Clinical Trials Call Center | London |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Australia, Czech Republic, Germany, Italy, Netherlands, Switzerland, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Occurrence, intensity and causal relationship of any (solicited/unsolicited adverse event) general symptoms | Full course of vaccination | ||
Primary | Incidence of serious adverse events | Study period | ||
Primary | Anti-HBs antibody concentrations | At Month 7 | ||
Secondary | Occurrence and intensity of solicited local signs and symptoms | 4-day after vaccination | ||
Secondary | Occurrence, intensity and relationship to vaccination of solicited general signs and symptoms | 4-day after vaccination | ||
Secondary | Occurrence, intensity and relationship to vaccination of unsolicited signs and symptoms | 30 days after vaccination | ||
Secondary | Occurrence and relationship to vaccination of SAEs | During the study period | ||
Secondary | Anti-HBs antibody concentrations | At Months 1, 2, 6 and 7 |
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