Last updated: 11/04/2018 00:47:52
An open randomised study to compare the immunogenicity of different doses and schedules of GSK's candidate prophylactic Herpes Simplex Virus vaccine (gD-AS04) in healthy HSV seronegative subjects aged 10-15 and 16-18 years to healthy HSV seronegative adults (aged 19-45 years) receiving the vaccine on a 0, 1, 6-month schedule.
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: An open randomised study to compare the immunogenicity of different doses and schedules of GSK's candidate prophylactic Herpes Simplex Virus vaccine (gD-AS04) in healthy HSV seronegative subjects aged 10-15 and 16-18 years to healthy HSV seronegative adults (aged 19-45 years) receiving the vaccine on a 0, 1, 6-month schedule.
Trial description: An open randomised study to compare the immunogenicity of different doses and schedules of GSK's candidate prophylactic Herpes Simplex Virus vaccine (gD-AS04) in healthy HSV seronegative subjects aged 10-15 and 16-18 years to healthy HSV seronegative adults (aged 19-45 years) receiving the vaccine on a 0, 1, 6-month schedule.
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:
2004-15-05
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Herpes Simplex Virus Vaccines
Product
SB208141
Collaborators
Not applicable
Study date(s)
September 2003 to May 2004
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
2004-15-05
Actual study completion date
2004-15-05
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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