Safety and Immunogenicity of 3 Lots of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Volunteers ≥ 15y
NCT ID: NCT00696917
Last Updated: 2008-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
1303 participants
INTERVENTIONAL
1999-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group A
Three doses according to 0, 1, 6-month schedule
Engerix™-B
3-dose intramuscular injection
Group B
Two doses according to 0, 6-month schedule, with a placebo injection at Month 1
HBV-MPL vaccine 208129
2-dose intramuscular injection 3 different vaccine lots
Group C
Two doses according to 0, 6-month schedule, with a placebo injection at Month 1
HBV-MPL vaccine 208129
2-dose intramuscular injection 3 different vaccine lots
Group D
Two doses according to 0, 6-month schedule, with a placebo injection at Month 1
HBV-MPL vaccine 208129
2-dose intramuscular injection 3 different vaccine lots
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
HBV-MPL vaccine 208129
2-dose intramuscular injection 3 different vaccine lots
Engerix™-B
3-dose intramuscular injection
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
15 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
GlaxoSmithKline
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
GSK
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
GSK Clinical Trials Call Center
Parkville, Victoria, Australia
GSK Clinical Trials Call Center
Hradec Kralové, , Czechia
GSK Clinical Trials Call Center
München, , Germany
GSK Clinical Trials Call Center
Bari, , Italy
GSK Clinical Trials Call Center
Utrecht, , Netherlands
GSK Clinical Trials Call Center
Lausanne, , Switzerland
GSK Clinical Trials Call Center
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
208129/031
Identifier Type: -
Identifier Source: org_study_id