N/A
Completed N=3,605
GARDASIL Reexamination Study (V501-059)
Source: ClinicalTrials.gov NCT01062074 ↗Enrolled (actual)
3,605
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcomePrimary: Percentage of Participants With Any Adverse Experience — 11.29 Percent of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Any Adverse Experience |
11.29 | — |
| PRIMARY Percentage of Participants With Any Adverse Drug Reaction |
9.02 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01062074). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.