Last updated: 10/30/2019 11:50:04
A double-blind, controlled, randomised, phase I dose-range study to assess the safety and imunogenicity of an HPV-VLP vaccine against Human Papillomavirus Types 31 and 45 evaluated in Healthy Adult Female Volunteers in a 0, 1, 6 months schedule
Clinicaltrials.gov ID
Not applicable
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A double-blind, controlled, randomised, phase I dose-range study to assess the safety and imunogenicity of an HPV-VLP vaccine against Human Papillomavirus Types 31 and 45 evaluated in Healthy Adult Female Volunteers in a 0, 1, 6 months schedule
Trial description: A double-blind, controlled, randomised, phase I dose-range study to assess the safety and imunogenicity of an HPV-VLP vaccine against Human Papillomavirus Types 31 and 45 evaluated in Healthy Adult Female Volunteers in a 0, 1, 6 months 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:
2005-04-08
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Human Papillomavirus
Product
GSK568893A
Collaborators
Not applicable
Study date(s)
September 2004 to August 2005
Type
Interventional
Phase
1
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2005-04-08
Actual study completion date
2005-04-08
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
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website