Last updated: 11/04/2018 00:34:53
Safety and immunogenicity of 3 lots of GSK Biologicals' HBV-MPL vaccine and Engerix™-B in healthy volunteers ≥ 15y
GSK study ID
208129/031
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:
Occurrence, intensity and causal relationship of any (solicited/unsolicited adverse event) general symptoms
Timeframe: Full course of vaccination
Incidence of serious adverse events
Timeframe: Study period
Anti-HBs antibody concentrations
Timeframe: At Month 7
Secondary outcomes:
Occurrence and intensity of solicited local signs and symptoms
Timeframe: 4-day after vaccination
Occurrence, intensity and relationship to vaccination of solicited general signs and symptoms
Timeframe: 4-day after vaccination
Occurrence, intensity and relationship to vaccination of unsolicited signs and symptoms
Timeframe: 30 days after vaccination
Occurrence and relationship to vaccination of SAEs
Timeframe: During the study period
Anti-HBs antibody concentrations
Timeframe: At Months 1, 2, 6 and 7
Interventions:
Biological/vaccine: HBV-MPL vaccine 208129
Biological/vaccine: Engerix™-B
Enrollment:
1303
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Hepatitis B
Product
Hepatitis B Vaccine, Recombinant
Collaborators
Not applicable
Study date(s)
April 1999 to February 2000
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
15+ years
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion 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
Trial location(s)
Location
GSK Clinical Trials Call Center
Parkville, Victoria, Australia, 3052
Status
Study Complete
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2000-29-02
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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