Clinical trial · Observational
Study Assessing Risk of Autoimmune Diseases in Females (9 - 25 Years) Exposed to Cervarix® in United Kingdom
An Observational Cohort Study to Assess the Risk of Autoimmune Diseases in Adolescent and Young Adult Women Aged 9 to 25 Years Exposed to Cervarix® in the United Kingdom
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an observational cohort study to assess the risk of autoimmune disease(s) within 12 months of receiving the first dose of Cervarix® in the exposed cohort and over a comparable period in the unexposed cohorts. This is an alternative study by GSK using the CPRD database in the UK to fulfil the US FDA safety commitment. The UK has had sufficient Cervarix® vaccination coverage during the period mid-September 2008 to 2011 to allow suitable data to be collected.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Infections, Papillomavirus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Data collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- Cervarix vaccinated (exposed) female cohort
- description
- Female subjects vaccinated with at least one dose of Cervarix® between the ages of 9 to 25 years.
- interventionNames
- Other: Data collection
- label
- Unexposed historical female cohort
- description
- Unexposed female subjects identified from historical data, will be frequency matched for age and practice region identifier to the subjects included in the vaccinated (exposed) cohort.
- interventionNames
- Other: Data collection
- label
- Unexposed concurrent male cohort
- description
- Male population is composed of 9- to 25-year-old male subjects not vaccinated with Cervarix®.
- interventionNames
- Other: Data collection
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 9 Years
- Maximum age
- 25 Years
Show eligibility criteria text
Inclusion Criteria: Note: Other vaccines are allowed in this study regardless of the time of administration and the time interval between subsequent doses. Inclusion criteria for the exposed female cohort: * Female aged from 9 to 25 years at the reference date (01 September 2008 through 31 August 2010). * Recorded in the CPRD GOLD for at least 12 months before the reference date. * The first dose of Cervarix received between 01 September 2008 through 31 August 2010, Full date (day/month/year) of Cervarix vaccination(s) available. * Subject defined as acceptable in CPRD GOLD. Inclusion criteria for the unexposed historical female cohort: * Female aged 9 to 25 years at the reference date (01 September 2005 through 31 August 2007). * Recorded in the CPRD GOLD for at least 12 months before the reference date. * Subject defined as acceptable in CPRD GOLD. Inclusion criteria for the unexposed concurrent male cohort: * Male aged 9 to 25 years at the reference date (01 September 2008 through 31 August 2010). * Recorded in the CPRD GOLD for at least 12 months before the reference date. * Subject defined as acceptable in CPRD GOLD. Inclusion criteria for the unexposed historical male cohort: * Male aged 9 to 25 years at the reference date (01 September 2005 through 31 August 2007). * Recorded in the CPRD GOLD for at least 12 months before the reference date. * Subject defined as acceptable in CPRD GOLD. Exclusion Criteria: Exclusion criteria for all cohorts: * Subjects with a diagnostic code of any auto-immune disease during the year prior to the reference date. * Subjects who received at least one dose of unspecified HPV vaccine or Gardasil at any time before the reference date. * Subjects who have been included in the other cohort. Exclusion criteria for the non-exposed cohorts: • Subjects who received any dose of Cervarix at any time before the reference date.
References
Publications (0)
Data not yet available