Clinical trial · Observational
GARDASIL Reexamination Study (V501-059)
Re-examination Study for General Vaccine Use to Assess the Safety Profile of GARDASIL in Usual Practice
NCT01062074CI-TRIAL-00027032completedResults postedClinicalTrials.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 survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of Gardasil through collecting the safety information according to the Re-examination Regulation for New Drugs.
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 |
|---|---|---|---|
| Human Papillomavirus (HPV) Infection | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Korean Participants Vaccinated with GARDASIL
- description
- Females and males 9-26 years old who are vaccinated with GARDASIL in usual practice. The GARDASIL vaccination series consists of three 0.5-mL intramuscular injections. The second and third doses are to be administered 2 months and 6 months after the first dose, respectively.
Primary outcomes (2)
- measure
- Percentage of Participants With Any Adverse Experience
- timeFrame
- Up to 14 days after any GARDASIL vaccination
- description
- An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience.
- measure
- Percentage of Participants With Any Adverse Drug Reaction
- timeFrame
- Up to 14 days after any GARDASIL vaccination
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 9 Years
- Maximum age
- 26 Years
Show eligibility criteria text
Inclusion Criteria: * Females and males 9-26 years of age who Are Vaccinated With The First Dose Of Gardasil For The Prevention Of Any Disease Caused By Human Papillomavirus (e.g., Cervical Cancer, Genital Warts, etc.) Within Local Labeling Exclusion Criteria: * Participant Who Has A Contraindication To Gardasil According To The Local Label * Participants Who Are Vaccinated With Gardasil Before Study Start
References
Publications (0)
Data not yet available
No reference posted for this study.