Overview
Sponsor-declared trial summary
HPV infection and related diseases, such as cervical intraepithelial neoplasia grade 2 and 3 and cervical cancer.
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.
Key facts
- Sponsor
- Region Stockholm
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 29 Nov 2024 → ongoing
- Decision date (initial)
- 2024-11-29
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-518857-41-00
- EudraCT number
- 2020-001169-34
- ClinicalTrials.gov
- NCT04910802
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis, Others
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 objectives 3
- 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.
- 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.
- 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.
Conditions and MedDRA coding
HPV infection and related diseases, such as cervical intraepithelial neoplasia grade 2 and 3 and cervical cancer.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10008229 | Cervical cancer | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 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 6
- Known history of severe allergic reaction or hypersensitivty to any of the components of the HPV vaccine. For GARDASIL 9: Amorphous aluminium hydroxyphosphate sulphate adjuvant, Sodium chloride, L-histidine, Polysorbate 80 or Sodium borate.
- Known history of immune-related disorders.
- Current acute severe febrile illness, except for minor infections such as a cold, mild upper respiratory infection or low-grade fever.
- Administration of immunoglobulin or blood-derived products within 6 months prior to scheduled HPV vaccine first dose.
- Current pregnancy (reported).
- Hysterectomized women.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Uptake of HPV vaccine in eligible women, by county and age strata.
Secondary endpoints 1
- Compliance with HPV vaccine administration Schedule.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD7273288 · Product
- Active substance
- Human Papillomavirus Type 31 L1 Protein - Adsorbed - in the Form of Virus-Like Particles Produced in Yeast Cells (Saccharomyces Cerevisiae Canade 3C-5 (Strain 1895)) by Rdna
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAVENOUS/SUBCUTANEOUS/INTRAMUSCULAR
- Max daily dose
- 1 Other
- Max total dose
- 2 Other
- Max treatment duration
- 42 Month(s)
- Authorisation status
- Authorised
- ATC code
- J07BM03 — -
- Marketing authorisation
- EU/1/15/1007/004
- MA holder
- MERCK SHARP & DOHME B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Stockholm
- Sponsor organisation
- Region Stockholm
- Address
- Lindhagensgatan 98, Vastermalm Vastermalm
- City
- Stockholm
- Postcode
- 112 18
- Country
- Sweden
Scientific contact point
- Organisation
- Region Stockholm
- Contact name
- Joakim Dillner
Public contact point
- Organisation
- Region Stockholm
- Contact name
- Joakim Dillner
Locations
1 EU/EEA country · 21 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ongoing, recruiting | 150,000 | 21 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Sweden | 2024-11-29 | 2024-11-29 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 9 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Study_Protocol_Catch-up | 1 |
| Protocol (for publication) | Study_Protocol_Catch-up_clean_241205 | 2 |
| Protocol (for publication) | Study_Protocol_Catch-up_trackchanges_241205 | 2 |
| Recruitment arrangements (for publication) | Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | Recruitment arrangements_241216 | 2 |
| Subject information and informed consent form (for publication) | Forskningspersonsinformation | 1 |
| Subject information and informed consent form (for publication) | Forskningspersonsinformation_clean 241205 | 2 |
| Subject information and informed consent form (for publication) | Forskningspersonsinformation_track-changes 241205 | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | Summary of Product Characteristics | 2 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-19 | Sweden | Acceptable 2024-11-29
|
2024-11-29 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-01-02 | Sweden | Acceptable 2025-02-21
|
2025-02-21 |