Trial Outcomes & Findings for GARDASIL Reexamination Study (V501-059) (NCT NCT01062074)
NCT ID: NCT01062074
Last Updated: 2017-04-17
Results Overview
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.
COMPLETED
3605 participants
Up to 14 days after any GARDASIL vaccination
2017-04-17
Participant Flow
Participant milestones
| Measure |
Korean Participants
Korean participants who received vaccination with GARDASIL, had Case Report Forms available, and did not violate the protocol
|
|---|---|
|
Overall Study
STARTED
|
3605
|
|
Overall Study
COMPLETED
|
3605
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
GARDASIL Reexamination Study (V501-059)
Baseline characteristics by cohort
| Measure |
Korean Participants
n=3605 Participants
Korean participants who received vaccination with GARDASIL, had Case Report Forms available, and did not violate the protocol
|
|---|---|
|
Age, Continuous
|
20.79 Years
STANDARD_DEVIATION 4.02 • n=5 Participants
|
|
Age, Customized
<12 years
|
122 Participants
n=5 Participants
|
|
Age, Customized
>=12 years and <19 years
|
735 Participants
n=5 Participants
|
|
Age, Customized
>=19 years
|
2748 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3549 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 14 days after any GARDASIL vaccinationPopulation: Participants who received at least 1 vaccination with GARDASIL, had Case Report Forms available, and did not violate the protocol
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.
Outcome measures
| Measure |
Korean Participants
n=3605 Participants
Korean participants who received vaccination with GARDASIL, had Case Report Forms available, and did not violate the protocol
|
|---|---|
|
Percentage of Participants With Any Adverse Experience
|
11.29 Percent of participants
|
PRIMARY outcome
Timeframe: Up to 14 days after any GARDASIL vaccinationPopulation: Participants who received at least 1 vaccination with GARDASIL, had Case Report Forms available, and did not violate the protocol
An adverse drug reaction was an adverse experience for which a causal relationship to the study drug could not be ruled out
Outcome measures
| Measure |
Korean Participants
n=3605 Participants
Korean participants who received vaccination with GARDASIL, had Case Report Forms available, and did not violate the protocol
|
|---|---|
|
Percentage of Participants With Any Adverse Drug Reaction
|
9.02 Percent of participants
|
Adverse Events
Korean Participants
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Korean Participants
n=3605 participants at risk
Korean participants who received vaccination with GARDASIL, had Case Report Forms available, and did not violate the protocol
|
|---|---|
|
General disorders
Injection-site pain
|
9.2%
330/3605 • Number of events 504 • Up to 14 days after any GARDASIL vaccination
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee With regard to surveillance results, any publication should be agreed by the sponsor in advance
- Publication restrictions are in place
Restriction type: OTHER