Last updated: 11/26/2018 16:40:23
A double-blind randomised, comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A – hepatitis B vaccine when administered in healthy adults.
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 randomised, comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A – hepatitis B vaccine when administered in healthy adults.
Trial description: A double-blind randomised, comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A – hepatitis B vaccine when administered in healthy adults.
Primary purpose:
Not applicable
Trial design:
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Masking:
Not applicable
Allocation:
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Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
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Enrollment:
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Primary completion date:
Not applicable
Observational study model:
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Time perspective:
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Clinical publications:
Van Damme P, Leroux-Roels G, Law B, Diaz-Mitoma F, Desombere I, Collard F, Tornieporth N, Van Herck K. 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. 2001 Sep;65(1):6-13. PMID:11505437
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 CISTM9, Lisbon, Portugal, 01 May 2005
Van Herck K et al. (2007) Ten-year antibody persistence induced by hepatitis A and B vaccine (Twinrix) in adults. Travel Med Infect Dis. 5 (3):171-175
Medical condition
Hepatitis A
Product
Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine
Collaborators
Not applicable
Study date(s)
N/A to Invalid Date
Type
Not applicable
Phase
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
Not applicable
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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