Clinical trial · Observational
Post-marketing Safety Study to Assess the Risk of Spontaneous Abortions in Women Exposed to Cervarix Residing in UK
Post-marketing Safety Study to Assess the Risk of Spontaneous Abortions in Women 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 study will assess the risk of spontaneous abortion during weeks 1-23 and weeks 1-19 of gestation, respectively, and other pregnancy outcomes, in an exposed cohort, i.e. women with last menstrual period (LMP) between 30 days before and 45 days after, or 30 days before and 90 days after any dose of Cervarix, when compared to a non-exposed cohort, i.e. women with LMP between 120 days and 18 months after the last Cervarix dose. The data collected in the Clinical Practice Research Datalink General Practitioner OnLine Database (CPRD GOLD) in the UK, will be analysed in this study.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cervarix | Biological | — | UNRESOLVED |
| Data Collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Exposed cohort
- description
- Women with the first day of LMP between 30 days before and 45 days after any Cervarix dose and between 30 days before and 90 days after any Cervarix dose.
- interventionNames
- Other: Data Collection
- Biological: Cervarix
- label
- Non-exposed cohort
- description
- Women with the first day of LMP between 120 days and 18 months after their last Cervarix dose (and no further Cervarix dose before the outcome).
- interventionNames
- Other: Data Collection
- Biological: Cervarix
Primary outcomes (1)
- measure
- Occurrence of spontaneous abortion
- timeFrame
- Weeks 1-23 of gestation
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 15 Years
- Maximum age
- 25 Years
Show eligibility criteria text
Inclusion Criteria: For the exposed cohort: All subjects must satisfy all of the following criteria at entry into the exposed cohort: * Full date of first day of LMP available in the database or calculated from Estimated date of delivery (EDD). * Female, aged between, and including, 15 and 25 years of age at LMP. * Recorded in the CPRD GOLD for at least 12 months at LMP. * First day of LMP available in the database or calculated from EDD between September 1st 2008 and June 30th 2011. * At least one dose of Cervarix received between September 1st 2008 and June 30th 2011. * Full date of Cervarix vaccination(s) available. * First day of LMP available in the database or calculated from EDD between 30 days before and 90 days after any dose of Cervarix. * Subject defined as acceptable in CPRD GOLD. For the non-exposed cohort: All subjects must satisfy all of the following criteria at entry into the non-exposed cohort: * Full date of first day of LMP available in the database or calculated from EDD. * Female, aged between, and including, 15 and 25 years of age at LMP. * Recorded in the CPRD GOLD since at least 12 months at LMP. * First day of LMP available in the database or calculated from EDD between September 1st 2008 and June 30th 2011. * At least one dose of Cervarix received between September 1st 2008 and June 30th 2011. * Full date of Cervarix vaccination(s) available. * First day of LMP available in the database or calculated from EDD between 120 days and 18 months after the last dose of Cervarix. * Subject defined as acceptable in CPRD GOLD. Exclusion Criteria: For the exposed cohort: • Female with the first day LMP between 30 days before and 90 days after at least one dose of unspecified Human Papillomavirus vaccine and/or Gardasil. For the non-exposed cohort: * Female with the first day LMP between 30 days before and 90 days after at least one dose of unspecified Human Papillomavirus vaccine and/or Gardasil. * Female included for a previous pregnancy in the exposed cohort.
References
Publications (0)
Data not yet available