Last updated: 11/06/2018 23:35:58
A phase III, open, randomized, multicentre study to demonstrate the non-inferiority of GlaxoSmithKline Biologicals' combined hepatitis A and hepatitis B vaccine Twinrix (720/20) according to a 0, 1 and 6 month schedule, to the monovalent hepatitis A vaccine Havrix 1440 (0, 6 months) and hepatitis B vaccine Engerix-B 20 µg (0, 1, 6 months) separately administered, in healthy adults aged between 18 and 40 years.
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 phase III, open, randomized, multicentre study to demonstrate the non-inferiority of GlaxoSmithKline Biologicals' combined hepatitis A and hepatitis B vaccine Twinrix (720/20) according to a 0, 1 and 6 month schedule, to the monovalent hepatitis A vaccine Havrix 1440 (0, 6 months) and hepatitis B vaccine Engerix-B 20 µg (0, 1, 6 months) separately administered, in healthy adults aged between 18 and 40 years.
Trial description: A phase III, open, randomized, multicentre study to demonstrate the non-inferiority of GlaxoSmithKline Biologicals' combined hepatitis A and hepatitis B vaccine Twinrix (720/20) according to a 0, 1 and 6 month schedule, to the monovalent hepatitis A vaccine Havrix 1440 (0, 6 months) and hepatitis B vaccine Engerix-B 20 µg (0, 1, 6 months) separately administered, in healthy adults aged between 18 and 40 years.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
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Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Tatochenko VK et al. (2006) Results of Russian multicenter trial of immunogenicity, reactogenicity and safety of new combination vaccine against hepatitis A and B (Twinrix). Zh Mikrobiol Epidemiol Immunobiol. 6:30-35.
Medical condition
Viral Hepatitis Vaccines
Product
SB208127
Collaborators
Not applicable
Study date(s)
May 2004 to January 2005
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
2005-13-01
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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