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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00696917




Registration number
NCT00696917
Ethics application status
Date submitted
11/06/2008
Date registered
13/06/2008
Date last updated
13/06/2008

Titles & IDs
Public title
Safety and Immunogenicity of 3 Lots of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Volunteers = 15y
Scientific 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
Secondary ID [1] 0 0
208129/031
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis B 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - HBV-MPL vaccine 208129
Other interventions - Engerix™-B

Active Comparator: Group A - Three doses according to 0, 1, 6-month schedule

Experimental: Group B - Two doses according to 0, 6-month schedule, with a placebo injection at Month 1

Experimental: Group C - Two doses according to 0, 6-month schedule, with a placebo injection at Month 1

Experimental: Group D - Two doses according to 0, 6-month schedule, with a placebo injection at Month 1


Other interventions: HBV-MPL vaccine 208129
2-dose intramuscular injection 3 different vaccine lots

Other interventions: Engerix™-B
3-dose intramuscular injection
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Occurrence, intensity and causal relationship of any (solicited/unsolicited adverse event) general symptoms
Timepoint [1] 0 0
Full course of vaccination
Primary outcome [2] 0 0
Incidence of serious adverse events
Timepoint [2] 0 0
Study period
Primary outcome [3] 0 0
Anti-HBs antibody concentrations
Timepoint [3] 0 0
At Month 7
Secondary outcome [1] 0 0
Occurrence and intensity of solicited local signs and symptoms
Timepoint [1] 0 0
4-day after vaccination
Secondary outcome [2] 0 0
Occurrence, intensity and relationship to vaccination of solicited general signs and symptoms
Timepoint [2] 0 0
4-day after vaccination
Secondary outcome [3] 0 0
Occurrence, intensity and relationship to vaccination of unsolicited signs and symptoms
Timepoint [3] 0 0
30 days after vaccination
Secondary outcome [4] 0 0
Occurrence and relationship to vaccination of SAEs
Timepoint [4] 0 0
During the study period
Secondary outcome [5] 0 0
Anti-HBs antibody concentrations
Timepoint [5] 0 0
At Months 1, 2, 6 and 7

Eligibility
Key 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
Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/1999
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
1303
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
GSK Clinical Trials Call Center - Parkville
Recruitment postcode(s) [1] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
Czech Republic
State/province [1] 0 0
Hradec Kralové
Country [2] 0 0
Germany
State/province [2] 0 0
München
Country [3] 0 0
Italy
State/province [3] 0 0
Bari
Country [4] 0 0
Netherlands
State/province [4] 0 0
Utrecht
Country [5] 0 0
Switzerland
State/province [5] 0 0
Lausanne
Country [6] 0 0
United Kingdom
State/province [6] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00696917
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00696917