Clinical trial · Observational
Post-marketing Safety Study of Autoimmune Diseases Following Cervarix® Vaccination
Post-marketing Safety Study of Autoimmune Diseases Following Cervarix® Vaccination in Females Aged 9-25 Years in the US
NCT01153906CI-TRIAL-00016179completedClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this post-marketing study is to evaluate the incidence of autoimmune diseases (AIDs) following females who have received at the least the first dose of Cervarix® as part of their routine health care.
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 (2)
- label
- Exposed cohort
- description
- Females 9-25 years of age, who received at least one dose of Cervarix® as part of their routine health care.
- interventionNames
- Other: Data collection
- label
- Unexposed cohort
- description
- Females 9-25 years of age, who did not receive Cervarix®
- interventionNames
- Other: Data collection
Primary outcomes (1)
- measure
- Occurrence of new cases of confirmed neuroinflammatory autoimmune diseases and other autoimmune diseases.
- timeFrame
- During the 12-month period following administration of at least the first dose of Cervarix® among the exposed cohort and during an equivalent time period among the unexposed cohort.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 9 Years
- Maximum age
- 25 Years
Show eligibility criteria text
Inclusion Criteria: Both cohorts: * Have complete medical insurance coverage and pharmacy benefits. * Enrolled female health plan members for at least one year prior to study entry. * Age between 9 and 25 years at study entry. Exposed cohort: • Subjects who have received at least one dose of Cervarix®, with or without any other US age-appropriate recommended vaccines. Unexposed cohort: • No further specific inclusion criteria Exclusion Criteria: Both cohorts: • Subjects with a diagnostic code of any of the AID endpoints of interest during the one year prior to the index date. Exposed cohort: • Subjects who received any dose of Gardasil® prior to the first dose of Cervarix®. Unexposed cohort: • Subjects who receive any dose of Cervarix® prior to the index date.
References
Publications (0)
Data not yet available
No reference posted for this study.