Human Papillomavirus (HPV) Infection
Conditions
Brief 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.
Interventions
None listed
Sponsors
Merck Sharp & Dohme LLC
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
9 Years to 26 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Any Adverse Experience | Up to 14 days after any GARDASIL vaccination | 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. |
| Percentage of Participants With Any Adverse Drug Reaction | Up to 14 days after any GARDASIL vaccination | An adverse drug reaction was an adverse experience for which a causal relationship to the study drug could not be ruled out |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Korean Participants Korean participants who received vaccination with GARDASIL, had Case Report Forms available, and did not violate the protocol | 3,605 |
| Total | 3,605 |
Baseline characteristics
| Characteristic | Korean Participants |
|---|---|
| Age, Continuous | 20.79 Years STANDARD_DEVIATION 4.02 |
| Age, Customized <12 years | 122 Participants |
| Age, Customized >=12 years and <19 years | 735 Participants |
| Age, Customized >=19 years | 2748 Participants |
| Sex: Female, Male Female | 3549 Participants |
| Sex: Female, Male Male | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 330 / 3,605 |
| serious Total, serious adverse events | 0 / 3,605 |
Outcome results
Primary
Percentage of Participants With Any Adverse Drug Reaction
An adverse drug reaction was an adverse experience for which a causal relationship to the study drug could not be ruled out
Time frame: Up to 14 days after any GARDASIL vaccination
Population: Participants who received at least 1 vaccination with GARDASIL, had Case Report Forms available, and did not violate the protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Korean Participants | Percentage of Participants With Any Adverse Drug Reaction | 9.02 Percent of participants |
Primary
Percentage of Participants With Any Adverse Experience
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.
Time frame: Up to 14 days after any GARDASIL vaccination
Population: Participants who received at least 1 vaccination with GARDASIL, had Case Report Forms available, and did not violate the protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Korean Participants | Percentage of Participants With Any Adverse Experience | 11.29 Percent of participants |