Last updated: 11/07/2018 14:58:42
A Phase I/II Study to evaluate the safety and immunogenicity of MEDI-517, a virus-like particle vaccine against human papillomavirus (HPV) types 16 and 18, in healthy adult female volunteers who are HPV-16 or HPV-18 DNA positive
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 I/II Study to evaluate the safety and immunogenicity of MEDI-517, a virus-like particle vaccine against human papillomavirus (HPV) types 16 and 18, in healthy adult female volunteers who are HPV-16 or HPV-18 DNA positive
Trial description: A Phase I/II Study to evaluate the safety and immunogenicity of MEDI-517, a virus-like particle vaccine against human papillomavirus (HPV) types 16 and 18, in healthy adult female volunteers who are HPV-16 or HPV-18 DNA positive
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:
Descamps D et al. (2009) Safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine for cervical cancer prevention: A pooled analysis of 11 clinical trials. Hum Vaccin. 5(5):51-59.
Descamps D et al. Safety of human papillomavirus (HPV)-16/18 AS04 adjuvanted vaccine for cervical cancer prevention: integrated summary of 11 clinical trials. Abstract presented at the 26th Annual Meeting of the ESPID. Graz, Austria, 13-17 May 2008.
Verstraeten T et al. (2008) Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 26(51):6630–6638.
Medical condition
Infections, Papillomavirus
Product
Human Papillomavirus Types 16 and 18 Vaccine
Collaborators
Not applicable
Study date(s)
November 1999 to June 2001
Type
Not applicable
Phase
1
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
2001-19-06
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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Access to clinical trial data by researchers
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