Women aged 23-25 that are invited and participating in the organised cervical screening program of Sweden will be offered 2 doses of Gardasil 9 at their first and second visit, with 3 years apart. This in line with WHO's directives to eliminate cervical cancer worldwide.

Concomitant HPV vaccination and HPV screening for rapid elimination of HPV infection and cervical cancer in Sweden - HPV Elimination

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001169-34-SE

Enrollment

150000

Registered

2021-02-01

Start date

2021-03-24

Completion date

Unknown

Last updated

2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HPV infection and related diseases, such as cervical intraepithelial neoplasia grade 2 and 3 and cervical cancer. MedDRA version: 21.1 Level: LLT Classification code 10008229 Term: Cervical cancer System Organ Class: 100000004864 MedDRA version: 21.1 Level: LLT Classification code 10056576 Term: Cervical intraepithelial neoplasia System Organ Class: 100000004872

Interventions

Trade Name: Gardasil 9 Product Name: Gardasil 9 Pharmaceutical Form: Suspension for injection INN or Proposed INN: HUMAN PAPILLOMAVIRUS TYPE 11 L1 PROTEIN Other descriptive name: HUMAN PAPILLOMAVIRUS

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150000 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Known history of severe allergic reaction or hypersensitivty to any of the components of the HPV vaccine. o For GARDASIL 9: Amorphous aluminium hydroxyphosphate sulphate adjuvant, Sodium chloride, L-histidine, Polysorbate 80 or Sodium borate 2. Known history of immune-related disorders 3. Current acute severe febrile illness, except for minor infections such as a cold, mild upper respiratory infection or low-grade fever. 4. Administration of immunoglobulin or blood-derived products within 6 months prior to scheduled HPV vaccine first dose 5. Current pregnancy (reported) 6. Hysterectomized women

Design outcomes

Primary

Measure	Time frame
Main Objective: The study aims to evaluate whether organised, concomitant HPV vaccination and HPV screening offered by the Swedish cervical screening program to all resident women aged 23-25 will result in a more rapid elimination of HPV infection in Sweden. This objective will be examined at the population level. ;Secondary Objective: The study will evaluate whether the addition of concomitant vaccination to the cervical screening program results in an improved efficiency and/or safety of the cervical screening program: 1)Protection of Gardasil 9 against HPV infection and against CIN2+ by Gardasil 9 HPV vaccine types. The effectiveness of one-dose vaccination, and to determine the effect of 2-dose vaccinations. 2)Efficiency will be measured by the yield of histopathologically confirmed high-grade cervical cancer precursors or cancer (cervical intraepithelial neoplasia grade 2, 3, or cervical cancer) in relation to the consumption of resources and convenience for the women. 3)Safety will be measured by evaluating the occurrence of obstetrical complications such as preterm births as well as by measuring the number of excised cervical specimens found to be histopathologically benign.;Primary end point(s): Prevalence of HPV infection in Sweden;Timepoint(s) of evaluation of this end point: End of the study	—

Measure

Time frame

Main Objective: The study aims to evaluate whether organised, concomitant HPV vaccination and HPV screening offered by the Swedish cervical screening program to all resident women aged 23-25 will result in a more rapid elimination of HPV infection in Sweden. This objective will be examined at the population level. ;Secondary Objective: The study will evaluate whether the addition of concomitant vaccination to the cervical screening program results in an improved efficiency and/or safety of the cervical screening program: 1)Protection of Gardasil 9 against HPV infection and against CIN2+ by Gardasil 9 HPV vaccine types. The effectiveness of one-dose vaccination, and to determine the effect of 2-dose vaccinations. 2)Efficiency will be measured by the yield of histopathologically confirmed high-grade cervical cancer precursors or cancer (cervical intraepithelial neoplasia grade 2, 3, or cervical cancer) in relation to the consumption of resources and convenience for the women. 3)Safety will be measured by evaluating the occurrence of obstetrical complications such as preterm births as well as by measuring the number of excised cervical specimens found to be histopathologically benign.;Primary end point(s): Prevalence of HPV infection in Sweden;Timepoint(s) of evaluation of this end point: End of the study

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Secondary

Measure	Time frame
Secondary end point(s): Histopathologically confirmed high-grade cervical cancer precursors or cancer (cervical intraepithelial neoplasia grade 2, 3, or cervical cancer) (CIN2+), by HPV type in the lesion. Consumption of resources. Number of screening and healthcare visits. Obstetrical complications, in particular preterm births. Excised cervical specimens found to be benign. ;Timepoint(s) of evaluation of this end point: End of the study	—

Measure

Time frame

Secondary end point(s): Histopathologically confirmed high-grade cervical cancer precursors or cancer (cervical intraepithelial neoplasia grade 2, 3, or cervical cancer) (CIN2+), by HPV type in the lesion. Consumption of resources. Number of screening and healthcare visits. Obstetrical complications, in particular preterm births. Excised cervical specimens found to be benign. ;Timepoint(s) of evaluation of this end point: End of the study

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Countries

Sweden

Contacts

Public ContactPrinciple Investigator

Region Stockholm

joakim.dillner@sll.se46724682460

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 8, 2026