Clinical trial · Observational
Drug Use Investigation for Cervarix®
NCT01187927CI-TRIAL-00016698completedClinicalTrials.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)
This post-marketing study was designed to assess safety and efficacy of Cervarix® vaccine in Japanese female subjects under conditions of actual use.
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 |
|---|---|---|---|
| Cervarix® | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Female subjects
- description
- Subjects received Cervarix® as per routine practice
- interventionNames
- Biological: Cervarix®
Primary outcomes (4)
- measure
- The number of subjects with solicited local adverse events
- timeFrame
- 7 days after vaccination
- description
- Local adverse events: pain, redness, swelling at the vaccination site
- measure
- The number of subjects with solicited general adverse events
- timeFrame
- 7 days after vaccination
- description
- General adverse events: fatigue, fever, gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal pain, etc.), headache, arthralgia, myalgia, urticaria, and rash
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 10 Years
Show eligibility criteria text
Inclusion Criteria: * Subject must be female * Subject must be aged 10 and over Exclusion Criteria: * Subject with obvious fever * Subject with obvious severe acute disease * Subject with hypersensitivity to any component of Cervarix® * Other than above, subject who is in inappropriate conditions for vaccination
References
Publications (0)
Data not yet available
No reference posted for this study.