Clinical trial • Phase III • Infectious Disease|Oncology

FluBHPVE6E7 for Human papillomavirus infection|HPV-associated precancerous lesions|HPV-associated cancers

Phase III trial of FluBHPVE6E7 for Human papillomavirus infection|HPV-associated precancerous lesions|HPV-associated cancers.

Overview

Trial Therapeutic Area
Infectious Disease|Oncology
Trial Disease
Human papillomavirus infection|HPV-associated precancerous lesions|HPV-associated cancers
Trial Stage
Phase III
Drug Modality
Vaccine

Key dates

Initial CTIS Submission Date
30-08-2024
First CTIS Authorization Date
20-09-2024

Trial design

Placebo (dose/schedule not specified)-controlled Phase III trial across 1 site in Slovakia.

Comparator
Placebo (dose/schedule not specified)
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
20

Eligibility

Recruits 20 Vulnerable population selected; no further details on consent or assent handling provided in the record..

Vulnerable Population
Vulnerable population selected; no further details on consent or assent handling provided in the record.

Recruitment

Planned Sample Size
20
Recruitment Window Months
36

Geography

Total Number Of Sites
1
Total Number Of Participants
20

Slovakia

Earliest CTIS Part Ii Submission Date
10-09-2024
Latest Decision Or Authorization Date
20-09-2024
Processing Time Days
10
Number Of Sites
1
Number Of Participants
20

Sites

Site Name
University Hospital Bratislava
Department Name
II. gynekologicko-pôrodnícka klinika Lekárska fakulta
Contact Person Name
Júlia Hederlingová
Contact Person Email
office@ru.unb.sk

Sponsor

Primary sponsor

Full Name
Bluesky Immunotherapies GmbH
Organisation Type
Pharmaceutical company
Country Of Registered Address
Austria

Investigational products

Investigational Product Name
FluBHPVE6E7
Modality
Vaccine
Dose Levels
Different dose levels (specific doses not specified)
Investigational Product Name
Placebo
Modality
Other

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