A database study to monitor the safety-related endpoints in female subjects aged between 9 and 45 years in China prior to and following Cervarix launch
Trial overview
Incidence of identifiable most common pIMDs among female participants aged 9-45 years, during pre- and post-GSK’s HPV vaccine launch periods
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)
Incidence of identifiable pregnancy outcomes among pregnant female participants aged 9-45 years, during pre- and post-GSK’s HPV vaccine launch periods
Timeframe: During pre- and post-GSK’s HPV vaccine launch period (1 January 2012 to 31 December 2017 and 1 January 2018 to 31 December 2020, respectively)
Performance of case identification method for the detection of pIMDs of interest and pregnancy outcomes of interest was assessed during pre-GSK’s HPV vaccine launch periods
Timeframe: During pre-GSK’s HPV vaccine launch period (1 January 2010 to 31 December 2017)
Incidence of pIMDs among female participants aged 9-45 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)
Incidence of pregnancy outcomes among pregnant female participants aged 9-45 years, during pre-GSK’s HPV vaccine launch period
Timeframe: During pre-GSK’s HPV vaccine launch period (1 January 2012 to 31 December 2017)
Incidence of identifiable most common pIMDs by vaccination strata in 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
Incidence rate of pregnancy outcomes among pregnant 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 2012 to 31 December 2017 and 1 January 2018 to 31 December 2020)
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 (1 January 2018 to 31 December 2020)
Probability of occurrence of identifiable most common pIMDs, in vaccinated and unvaccinated participants, during pre- and post-GSK’s HPV vaccine launch periods
Timeframe: During pre- and post-GSK’s HPV vaccine launch periods (1 January 2010 to 31 December 2017 and 1 January 2018 to 31 December 2020, respectively)
Probability of identifiable abnormal pregnancy outcomes in vaccinated and unvaccinated pregnant participants, during pre- and post-GSK’s HPV vaccine launch periods
Timeframe: During pre- and post-GSK’s HPV vaccine launch periods (1 January 2012 to 31 December 2017 and 1 January 2018 to 31 December 2020, respectively)
Participation criteria
- Female and male* permanent residents aged between 9-45 years and registered in the Yinzhou database/YRHIP during the observation period (1 January 2010 through 31 December 2020).
- Subjects 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 month or more apart.
- None
- Subjects 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 month or more apart. *Note: Male subjects will be included only to account for time-confounding bias.
Female and male* permanent residents aged between 9-45 years and registered in the Yinzhou database/YRHIP during the observation period (1 January 2010 through 31 December 2020).
- None
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.