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.

Phase 1

• Conditions: HPV infection and related diseases, such as cervical intraepithelial neoplasia grade 2 and 3 and cervical cancer.; MedDRA version: 21.1Level: LLTClassification code 10008229Term: Cervical cancerSystem Organ Class: 100000004864; MedDRA version: 21.1Level: LLTClassification code 10056576Term: Cervical intraepithelial neoplasiaSystem Organ Class: 100000004872; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-001169-34-SE
• Lead Sponsor: Region Stockholm

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-01
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 150000

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

1.Known history of severe allergic reaction or hypersensitivty to any of the components of the HPV vaccine.
oFor 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified