Clinical trial · Observational
Post-Approval Safety Monitoring Program to Assess the Safety Profile of GARDASIL in China Usual Practice
NCT03659110CI-TRIAL-00035065unknownClinicalTrials.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 is a post-Approval Safety Monitoring Program to assess the safety profile of GARDASIL in china usual practice.
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 |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HPV 4 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 1000 subjects receive the HPV 4 vaccine
- interventionNames
- Biological: HPV 4
Primary outcomes (2)
- measure
- Evaluate the Rate of Adverse reactions of GARDASIL in China usual practice
- timeFrame
- 24 months
- description
- Adverse reactions associated with vaccine will be observed in females Aged 20-45 Years after vaccination. Solicited local adverse events include Pain, Redness, Swelling, Induration, Rash, Pruritus at injection site. solicited general adverse events include Fever, Nausea, Vomiting, Diarrhea, Decreased appetite, Be agitated (irritability, abnormal crying), fatigue, allergy
- measure
- Number of participants with adverse events following any dose of vaccine
- timeFrame
- within 30 days after each dose
- description
- Number of participants with adverse events following any dose of vaccine
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Any person who is intended to be inoculated with first dose GARDASIL based on his/her own wishes at screening Exclusion Criteria: 1. Unable to provide written informed consent 2. Any woman who is known being pregnant at screening 3. Subject who is participating or going to participate in another study which involves GARDASIL administration
References
Publications (0)
Data not yet available
No reference posted for this study.