Clinical trial • Phase IV • Oncology

HUMAN PAPILLOMAVIRUS TYPE 31 L1 PROTEIN; HUMAN PAPILLOMAVIRUS TYPE 33 L1 PROTEIN; HUMAN PAPILLOMAVIRUS TYPE 45 L1 PROTEIN; HUMAN PAPILLOMAVIRUS TYPE 52 L1 PROTEIN; HUMAN PAPILLOMAVIRUS TYPE 58 L1 PROTEIN; HUMAN PAPILLOMAVIRUS TYPE 11 L1 PROTEIN; HUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN; HUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN; HUMAN PAPILLOMAVIRUS TYPE 6 L1 PROTEIN for Human papillomavirus (HPV) infection | Cervical intraepithelial neoplasia (CIN2/3) | Cervical cancer

Phase IV trial of HUMAN PAPILLOMAVIRUS TYPE 31 L1 PROTEIN; HUMAN PAPILLOMAVIRUS TYPE 33 L1 PROTEIN; HUMAN PAPILLOMAVIRUS TYPE 45 L1 PROTEIN; HUMAN PAPILLO…

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Human papillomavirus (HPV) infection | Cervical intraepithelial neoplasia (CIN2/3) | Cervical cancer
Trial Stage
Phase IV
Drug Modality
Vaccine

Key dates

Initial CTIS Submission Date
19-11-2024
First CTIS Authorization Date
29-11-2024

Trial design

Phase IV trial across 21 sites in Sweden.

Target Sample Size
150000

Eligibility

Recruits 150000 No vulnerable populations selected. Participants are adult women (aged 23-25) who must provide informed consent. Subject information and informed consent form documents are listed in the trial documents (Forskningspersonsinformation), but no additional details on assent or special consent handling are provided in the record..

Pregnancy Exclusion
Current pregnancy (reported).
Vulnerable Population
No vulnerable populations selected. Participants are adult women (aged 23-25) who must provide informed consent. Subject information and informed consent form documents are listed in the trial documents (Forskningspersonsinformation), but no additional details on assent or special consent handling are provided in the record.

Inclusion criteria

  • {"criterion_text":"-Eligible women will include resident women within the age range of 23- 25 due for invitation to organised cervical cancer screening who consent to participate in the study."}

Exclusion criteria

  • {"criterion_text":"-Known history of severe allergic reaction or hypersensitvity to any of the components of the HPV vaccine.\tFor GARDASIL 9: Amorphous aluminium hydroxyphosphate sulphate adjuvant, Sodium chloride, L-histidine, Polysorbate 80 or Sodium borate.\n-Known history of immune-related disorders.\n-Current acute severe febrile illness, except for minor infections such as a cold, mild upper respiratory infection or low-grade fever.\n-Administration of immunoglobulin or blood-derived products within 6 months prior to scheduled HPV vaccine first dose.\n-Current pregnancy (reported).\n-Hysterectomized women."}

Endpoints

Primary endpoints

  • {"endpoint_text":"-Uptake of HPV vaccine in eligible women, by county and age strata.","definition_or_measurement_approach":"Measured as uptake rates of HPV vaccine among eligible women, reported by county and age strata."}

Secondary endpoints

  • {"endpoint_text":"-Compliance with HPV vaccine administration Schedule.","definition_or_measurement_approach":"Measured as compliance with the HPV vaccine administration schedule among vaccinated participants."}

Recruitment

Planned Sample Size
150000
Recruitment Window Months
80
Consent Approach
Informed consent is obtained from eligible adult participants (women aged 23-25) who consent to participate. Subject information and informed consent form documents are listed (Forskningspersonsinformation). No details on assent, age-specific documents, or languages are provided in the record.

Methods

  • Organised concomitant HPV vaccination and HPV screening offered by the Swedish cervical screening program to all resident women aged 23-25 due for invitation (country: Sweden).

Geography

Total Number Of Sites
21
Total Number Of Participants
150000

Sweden

Earliest CTIS Part Ii Submission Date
12-11-2024
Latest Decision Or Authorization Date
21-02-2025
Processing Time Days
101
Number Of Sites
21
Number Of Participants
150000

Sites

Site Name
Region Vaesternorrland
Department Name
Region Västernorrland
Contact Person Name
Josefina Sjökvist
Contact Person Email
josefina.sjokvist@rvn.se
Site Name
Region Halland
Department Name
Region Halland
Contact Person Name
Camilla Malm
Site Name
Region Gotland
Department Name
Region Gotland
Contact Person Name
Miriam Elfström
Site Name
Region Västerbotten
Department Name
Region Västerbotten
Contact Person Name
Sara Höglund
Site Name
Region Jönköping
Department Name
Region Jönköping
Contact Person Name
Linda Joki
Site Name
Region Örebro Län
Department Name
Region Örebro Län
Contact Person Name
Lovisa Bergengren
Site Name
Region Västmanland
Department Name
Region Västmanland
Contact Person Name
Björn Svartsgård
Site Name
Region Värmland
Department Name
Region Värmland
Contact Person Name
Ulrika Nilsson Lidström
Site Name
Region Norrbotten
Department Name
Region Norrbotten
Contact Person Name
Elisabeth Ökvist
Contact Person Email
elisabeth.okvist@norrbotten.se
Site Name
Region Sörmland
Department Name
Region Sörmland
Contact Person Name
chatarina Strömbäck
Site Name
Region Östergötland
Department Name
Region Östergötland
Contact Person Name
Linda Joki
Site Name
Västra Götalandsregionen
Department Name
Västragötalandsregionen
Contact Person Name
Carin Wrennfors
Contact Person Email
carin.wrennfors@vgregion.se
Site Name
Region Skåne
Department Name
Region Skåne
Contact Person Name
Marie Köhler
Contact Person Email
marie.kohler@skane.se
Site Name
Region Uppsala
Department Name
Region Uppsala
Contact Person Name
Elin Kinnman
Contact Person Email
elin.kinnmam@regionuppsala.se
Site Name
Region Jämtland Härjedalen
Department Name
Region Jämtland Härjedalen
Contact Person Name
Anna Ericsson
Contact Person Email
anna.ericsson@regionjh.se
Site Name
Region Kronoberg
Department Name
Region Kronoberg
Contact Person Name
Katja Dahl Nordström
Site Name
Region Kalmar Län
Department Name
Region Kalmar Län
Contact Person Name
Karin Dahl
Contact Person Email
karin.dahl@regionkalmar.se
Site Name
Region Dalarna
Department Name
Region Dalarna
Contact Person Name
Åsa Wiking
Contact Person Email
asa.wiking@regiondalarna.se
Site Name
Region Stockholm
Department Name
Region Stockholm
Contact Person Name
Miriam Elfström
Site Name
Region Blekinge
Department Name
Region Blekinge
Contact Person Name
Anna-Karin Åberg Sandberg
Site Name
Region Gävleborg
Department Name
Region Gävleborg
Contact Person Name
Jannika Lindblad

Sponsor

Primary sponsor

Full Name
Region Stockholm
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Sweden

Investigational products

Investigational Product Name
Gardasil 9 suspension for injection in a pre-filled syringe. Human Papillomavirus 9-valent Vaccine (Recombinant, adsorbed)
Active Substance
HUMAN PAPILLOMAVIRUS TYPE 31 L1 PROTEIN; HUMAN PAPILLOMAVIRUS TYPE 33 L1 PROTEIN; HUMAN PAPILLOMAVIRUS TYPE 45 L1 PROTEIN; HUMAN PAPILLOMAVIRUS TYPE 52 L1 PROTEIN; HUMAN PAPILLOMAVIRUS TYPE 58 L1 PROTEIN; HUMAN PAPILLOMAVIRUS TYPE 11 L1 PROTEIN; HUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN; HUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN; HUMAN PAPILLOMAVIRUS TYPE 6 L1 PROTEIN
Modality
Vaccine
Routes Of Administration
INTRAVENOUS/SUBCUTANEOUS/INTRAMUSCULAR
Route
INTRAVENOUS/SUBCUTANEOUS/INTRAMUSCULAR
Authorisation Status
Authorised (marketing authorisation EU/1/15/1007/004)

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