Clinical trial • Phase I • Infectious Disease
V540A vaccine for Human papillomavirus infection
Phase I trial of V540A vaccine for Human papillomavirus infection. Randomised. 204 participants.
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- Human papillomavirus infection
- Trial Stage
- Phase I
- Drug Modality
- Vaccine
Key dates
- Initial CTIS Submission Date
- 28-08-2024
- First CTIS Authorization Date
- 21-10-2024
Trial design
Randomised Phase I trial across 3 sites in Belgium.
- Randomised
- Yes
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 204
Eligibility
Recruits 204 Trial record indicates vulnerable population selected (isVulnerablePopulationSelected=true); no details on consent or assent in the provided documents..
- Vulnerable Population
- Trial record indicates vulnerable population selected (isVulnerablePopulationSelected=true); no details on consent or assent in the provided documents.
Recruitment
- Planned Sample Size
- 204
- Recruitment Window Months
- 20
Geography
- Total Number Of Sites
- 3
- Total Number Of Participants
- 204
Belgium
- Earliest CTIS Part Ii Submission Date
- 11-10-2024
- Latest Decision Or Authorization Date
- 11-08-2025
- Processing Time Days
- 304
- Number Of Sites
- 3
- Number Of Participants
- 144
Sites
- Site Name
- Advanced Technology Corporation
- Department Name
- Advanced Technology Corporation
- Contact Person Name
- Xaviere Rausin
- Contact Person Email
- xaviere.rausin@atc-pharma.be
- Site Name
- Anima
- Department Name
- Anima
- Contact Person Name
- Erik Buntinx
- Contact Person Email
- erik.buntinx@anima-alken.be
- Site Name
- SGS Clinical Pharmacology Unit
- Department Name
- SGS Clinical Pharmacology Unit
- Contact Person Name
- Thomas De Ridder
- Contact Person Email
- thomas.deridder@sgs.com
Sponsor
Primary sponsor
- Full Name
- Merck Sharp & Dohme LLC
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- V540A vaccine
- Modality
- Vaccine
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