A Phase 3 interventional study of Gardasil™ and Placebo in Papillomavirus Infections, sponsored by Merck Sharp & Dohme LLC. Completed. Open to female participants aged 9 Years to 23 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-02-04.
Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Prevention
This is an immunogenicity and safety study of Gardasil (V501) in females 9 to 23 years of age in Korea.
495 studies on the registry are indexed under Papillomavirus Infections; 125 are open to participants now.
This study's enrollment of 176 is below the median of 202 across 332 interventional studies indexed under Papillomavirus Infections.
Browse Papillomavirus Infections studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All Subjects:
Women Ages 16 to 23 Only:
Gardasil™ 3 dose regimen
Biological: Gardasil™
Gardasil™ matching placebo 3 dose regimen
Biological: Placebo
Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)
Also known as: V501
Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
Number of Participants Who Seroconvert to HPV 6.
Vaccine-induced anti-HPV 6 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 6 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 20 mMU/mL.
Time frame: Week 4 Postdose 3
Number of Participants Who Seroconvert to HPV 11.
Vaccine-induced anti-HPV 11 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 11 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 16 mMU/mL.
Time frame: Week 4 Postdose 3
Number of Participants Who Seroconvert to HPV 16.
Vaccine-induced anti-HPV 16 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 16 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 20 mMU/mL.
Time frame: Week 4 Postdose 3
Number of Participants Who Seroconvert to HPV 18.
Vaccine-induced anti-HPV 18 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 18 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 24 mMU/mL.
Time frame: Week 4 Postdose 3
Number of Participants With Adverse Experiences
Number of participants who reported 1 or more adverse experience.
Time frame: Overall study including 14 calendar days after the last vaccination visit.
Patients were recruited at 10 medical sites in Korea. First Patient Treated: 20-Oct-2005 Last Patient Treated: 24-Jun-2006
| Milestone | Gardasil™ | Placebo |
|---|---|---|
| Started | 117 | 59 |
| Vaccinated at dose 1 | 117 | 59 |
| Vaccinated at dose 2 | 117 | 59 |
| Vaccinated at dose 3 | 116 | 59 |
| Completed | 116 | 59 |
| Not completed | 1 | 0 |
| Withdrew: Death | 1 | 0 |
Vaccine-induced anti-HPV 6 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 6 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 20 mMU/mL.
| Participants | Gardasil™ | Placebo |
|---|---|---|
| Number of Participants Who Seroconvert to HPV 6. | 109 | 0 |
Vaccine-induced anti-HPV 11 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 11 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 16 mMU/mL.
| Participants | Gardasil™ | Placebo |
|---|---|---|
| Number of Participants Who Seroconvert to HPV 11. | 112 | 1 |
Vaccine-induced anti-HPV 16 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 16 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 20 mMU/mL.
| Participants | Gardasil™ | Placebo |
|---|---|---|
| Number of Participants Who Seroconvert to HPV 16. | 112 | 0 |
Vaccine-induced anti-HPV 18 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 18 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 24 mMU/mL.
| Participants | Gardasil™ | Placebo |
|---|---|---|
| Number of Participants Who Seroconvert to HPV 18. | 109 | 0 |
Number of participants who reported 1 or more adverse experience.
| Participants | Gardasil™ | Placebo |
|---|---|---|
| Discontinued due to an Adverse Experience (AE) | 0 | 0 |
| Discontinued due to vaccine related AE | 0 | 0 |
| Discontinued due to an Serious AE | 0 | 0 |
| Discontinued due to serious vaccine-related AE | 0 | 0 |
Collected over During the double-blind period including 14 calendar days after the last vaccination visit.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Gardasil™ | — | 1/117 (0.9%) | 88/117 (75.2%) |
| Placebo | — | 1/59 (1.7%) | 41/59 (69.5%) |
| Event | Gardasil™ | Placebo |
|---|---|---|
| Acute pharyngitisInfections and infestations | 0/117 | 1/59 |
| Traffic accidentInjury, poisoning and procedural complications | 1/117 | 0/59 |
| Event | Gardasil™ | Placebo |
|---|---|---|
| Injection site painGeneral disorders | 85/117 | 30/59 |
| Injection site swellingGeneral disorders | 33/117 | 7/59 |
| Injection site erythemaGeneral disorders | 27/117 | 4/59 |
| FeverGeneral disorders | 16/117 | 10/59 |
| ColdInfections and infestations | 10/117 | 10/59 |
| HeadacheNervous system disorders | 5/117 | 5/59 |
| Injection site tendernessGeneral disorders | 2/117 | 3/59 |
| Age, Continuous(years) | Gardasil™ | Placebo | Total |
|---|---|---|---|
| Mean | 16.7 ± 4.9 | 16.5 ± 5.2 | 16.6 ± 5.0 |
| Sex: Female, Male(Participants) | Gardasil™ | Placebo | Total |
|---|---|---|---|
| Female | 117 | 59 | 176 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(participants) | Gardasil™ | Placebo | Total |
|---|---|---|---|
| Number | 117 | 59 | 176 |
No study locations are listed for this record.
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Merck Sharp & Dohme LLC