Last updated: 11/07/2018 12:55:23
A double-blind, randomized study to evaluate the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals' combined hepatitis A / hepatitis B vaccine in healthy adult volunteers.
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A double-blind, randomized study to evaluate the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals' combined hepatitis A / hepatitis B vaccine in healthy adult volunteers.
Trial description: A double-blind, randomized study to evaluate the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals' combined hepatitis A / hepatitis B vaccine in healthy adult volunteers.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Van Damme P. 10 Year Persistence Data for Antibodies Induced by Immunisation with the First Combined Vaccine Against Hepatitis A and B in Adults. Abstract presented at the 9th Conference of the International Society of Travel Medicine (CISTM9), Lisbon, Portugal, 01 May 2005.
Van Damme P. et al. (2000) Long-Term Persistence of Antibodies Induced by Vaccination and Safety Follow-Up, With the First Combined Vaccine Against Hepatitis A and B in Children and Adults. J Med Virol. 65 (1):6-13.
Van Herck et al. (2007) Ten-year antibody persistence induced by hepatitis A and B vaccine (Twinrix) in adults. Travel Medicine and Infectious Disease. 5(3):171-175.
Medical condition
Viral Hepatitis Vaccines
Product
SB208127
Collaborators
Not applicable
Study date(s)
October 2003 to February 2006
Type
Not applicable
Phase
2/3
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2006-26-02
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
Not applicable
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