Last updated: 04/25/2024 07:40:53

A database study to monitor cervical cancer-related endpoints in female subjects aged between 9 and 45 years in China prior to and following Cervarix launch

GSK study ID
212381
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: A database study to monitor cervical cancer-related endpoints in female subjects aged between 9 and 45 years in China prior to and following Cervarix launch
Trial description: GSK’s Human Papillomavirus (HPV) vaccine was developed to help prevent cervical cancer caused by HPV types 16 and 18. This study was intended to assess cervical cancer-related endpoints in females aged between 9 and 45 years in China, by using a sequential approach, prior to and following GSK’s HPV vaccine launch, when GSK’s HPV vaccine was administered according to the local prescribing information.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Proportion of cervical cancer-related cases of interest with/without HPV type among female participants aged 9-70 years, during pre- and post-GSK’s HPV vaccine launch period

Timeframe: During pre- and post-GSK’s HPV vaccine launch period (1 January 2010 to 31 December 2017 and 1 January 2018 to 31 December 2020, respectively)

Proportion of cervical cancer-related cases of interest with/without HPV type among female participants aged 9-70 years within screened population, during pre- and post-GSK’s HPV vaccine launch period

Timeframe: During pre- and post-GSK’s HPV vaccine launch period (1 January 2010 to 31 December 2017 and 1 January 2018 to 31 December 2020, respectively)

Secondary outcomes:

Number of detected cervical cancer-related cases identified following the ICD-10 based case identification method among female participants aged 9-70 years, during pre-GSK’s HPV vaccine launch period

Timeframe: During pre-GSK’s HPV vaccine launch period (1 January 2010 to 31 December 2017)

Number of participants with HPV infection, cervical lesions CIN1, CIN2, CIN3 and cervical cancer with/without HPV type, during pre-GSK’s HPV vaccine launch period

Timeframe: During pre-GSK’s HPV vaccine launch period (1 January 2010 to 31 December 2017)

Number of participants with at least one dose of HPV vaccine administered during post-GSK’s HPV vaccine launch period

Timeframe: During post-GSK’s HPV vaccine launch period (1 January 2018 to 31 December 2020)

Number of participants with cervical cancer screening examinations, during pre- and post-GSK’s HPV vaccine launch period

Timeframe: During pre- and post-GSK’s HPV vaccine launch period (1 January 2010 to 31 December 2017 and 1 January 2018 to 31 December 2020, respectively)

Probability of occurrence of cervical cancer-related endpoints of interest with/without HPV type, among female participants aged 9-45 years, during pre- and post-GSK’s HPV vaccine launch period

Timeframe: During pre- and post-GSK’s HPV vaccine launch period (1 January 2010 to 31 December 2017 and 1 January 2018 to 31 December 2020, respectively)

Probability of occurrence of cervical cancer-related endpoints of interest with/without HPV type, among female participants aged 9-45 years within screened population, during pre- and post-GSK’s HPV vaccine launch period

Timeframe: During pre- and post-GSK’s HPV vaccine launch period (1 January 2010 to 31 December 2017 and 1 January 2018 to 31 December 2020, respectively)

Interventions:
Not applicable
Enrollment:
180000
Primary completion date:
2023-26-10
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Cervical Intraepithelial Neoplasia
Product
SB580299
Collaborators
Not applicable
Study date(s)
September 2021 to January 2024
Type
Observational
Phase
4

Participation criteria

Sex
Female
Age
9 - 70 Years
Accepts healthy volunteers
Yes
  • Female permanent residents aged between 9-70 years and registered in the Yinzhou database/YRHIP during the observational period (1 January 2010 through 31 December 2020).
  • Participants with at least 12 months (365 days) of continuous registration in YRHIP database over the study period, defined by minimum 2 or more observations recorded in YRHIP at 12 months or more apart.
  • None
Inclusion and exclusion criteria
Inclusion criteria:

    Female permanent residents aged between 9-70 years and registered in the Yinzhou database/YRHIP during the observational period (1 January 2010 through 31 December 2020).

    • Participants with at least 12 months (365 days) of continuous registration in YRHIP database over the study period, defined by minimum 2 or more observations recorded in YRHIP at 12 months or more apart.
Exclusion criteria:
  • None

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Ningbo, China, 315199
Status
Study Complete
Contact us

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
2023-26-10
Actual study completion date
2024-22-01

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