Clinical trial • Phase I • Infectious Disease

V540C vaccine for Human papillomavirus infection

Phase I trial of V540C vaccine for Human papillomavirus infection. 54 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
15-11-2024
First CTIS Authorization Date
08-01-2025

Trial design

Phase I trial across 3 sites in Belgium.

Target Sample Size
54

Recruitment

Planned Sample Size
54
Recruitment Window Months
25

Geography

Total Number Of Sites
3
Total Number Of Participants
54

Belgium

Earliest CTIS Part Ii Submission Date
13-12-2024
Latest Decision Or Authorization Date
22-09-2025
Processing Time Days
283
Number Of Sites
3
Number Of Participants
54

Sites

Site Name
Universitair Ziekenhuis Gent
Department Name
DRUG
Contact Person Name
Sylvie Rottey
Contact Person Email
sylvie.rottey@ugent.be
Site Name
SGS Belgium
Department Name
SGS Clinical Pharmacology Unit
Contact Person Name
Thomas De Ridder
Contact Person Email
thomas.deridder@sgs.com
Site Name
Advanced Technology Corporation
Department Name
Clinical Pharmacology Unit/A.T.C.
Contact Person Name
Paolo Battisti
Contact Person Email
paolo.battisti@inokura.be

Sponsor

Primary sponsor

Full Name
Merck Sharp & Dohme LLC
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Investigational products

Investigational Product Name
V540C vaccine
Modality
Vaccine

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