Last updated: 02/29/2024 18:30:16

Retrospective data base, PASS, case-control study to assess data on anal cancer in countries where GSK Biologicals’ HPV vaccine has been introduced in the NIP

GSK study ID
217743
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: An observational, retrospective database post-authorisation safety study (PASS) to assess trends and changes over time in incidence of anal cancer and feasibility for a case-control study in European countries that introduced Cervarix in their National Immunisation Programmes (NIP)
Trial description: The aim of this study is to assess trends and changes over time in incidence of anal cancer using data reported to the national cancer registries in Finland, the Netherlands, England, Denmark and Norway and to carry out an assessment of feasibility to conduct a case-control study in any of these 5 European countries aiming to determine the impact and effectiveness of GSK’s HPV vaccine against anal lesions and cancer in females and males.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Age-standardised incidence rates of anal cancer by sex, HPV-type and histological classification for each country separately

Timeframe: From 1992 until the most recent and complete available calendar year in the cancer registries (i.e., pre- and post- GSK's HPV vaccine launch period)

Crude incidence rates of anal cancer by age category, by sex, HPV-type and histological classification for each country separately

Timeframe: From 1992 until the most recent and complete available calendar year in the cancer registries (i.e., pre- and post- GSK's HPV vaccine launch period)

Incidence rates of small intestine cancer by age category and sex for each country separately

Timeframe: From 1992 until the most recent and complete available calendar year in the cancer registries (i.e., pre- and post- GSK's HPV vaccine launch period)

Secondary outcomes:

Number of anal cancer cases expected to demonstrate vaccine effectiveness for each country separately

Timeframe: From 1992 until the most recent and complete available calendar year in the cancer registries (i.e., pre- and post- GSK's HPV vaccine launch period)

Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2027-29-01
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Infections, Papillomavirus
Product
SB580299
Collaborators
The Finnish Cancer Registry (FCR), The Netherlands Cancer Registry (NCR), National Cancer Registration and Analysis Service (NCRAS), The Danish Cancer Registry, The Cancer Registry of Norway (CRN), Finnish National Vaccination Registry, Dutch vaccination registry (Præventis), Child Health Information Systems, England, Danish vaccination registry, Norwegian vaccination registry
Study date(s)
August 2021 to January 2027
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
0+ years
Accepts healthy volunteers
Yes
  • The following country eligibility criteria should be checked in order to perform analysis:
  • Should have a stable, consolidated, and validated cancer registry.
  • Not Applicable
Inclusion and exclusion criteria
Inclusion criteria:

    The following country eligibility criteria should be checked in order to perform analysis:

    • Should have a stable, consolidated, and validated cancer registry.
    • The cancer registry should preferably be population-based and nationwide.
    • Administration of GSK’s HPV vaccine for at least 5 birth cohorts (either routine or catch-up campaign cohorts) within the NIP.
Exclusion criteria:
  • Not Applicable

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Protocol
Available language(s): English
Download document(s)
Statistical analysis plan
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
Not applicable

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website