Clinical trial · Interventional
Human Papillomavirus (HPV) Registration Study (Gardasil)(V501-023)(COMPLETED)
An Immunogenicity and Safety Study of Gardasil (V501 (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine)) in Females 9 to 23 Years of Age in Korea
NCT00157950CI-TRIAL-00020788completedPhase 3Results 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 is an immunogenicity and safety study of Gardasil (V501) in females 9 to 23 years of age in Korea.
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 |
|---|---|---|---|
| Papillomavirus Infections | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gardasil™ | Biological | — | UNRESOLVED |
| Placebo | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Gardasil™
- description
- Gardasil™ 3 dose regimen
- interventionNames
- Biological: Gardasil™
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Gardasil™ matching placebo 3 dose regimen
- interventionNames
- Biological: Placebo
Primary outcomes (4)
- measure
- Number of Participants Who Seroconvert to HPV 6.
- timeFrame
- Week 4 Postdose 3
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 9 Years
- Maximum age
- 23 Years
Show eligibility criteria text
Inclusion Criteria: * Girls ages 9 to 15 years (must not yet have had coitarche) * Healthy females ages 16 to 23 years (individuals with a lifetime history of 0 to 3 male or female sexual partners) Exclusion Criteria: All Subjects: * History of known prior vaccination with an HPV vaccine. Women Ages 16 to 23 Only: * Individuals with any prior history of genital warts or treatment for genital warts. * Individuals with \> 3 lifetime male or female sexual partners.
References
Publications (2)
- BACKGROUNDKang S, Kim KH, Kim YT, Kim YT, Kim JH, Song YS, Shin SH, Ryu HS, Han JW, Kang JH, Park SY. Safety and immunogenicity of a vaccine targeting human papillomavirus types 6, 11, 16 and 18: a randomized, placebo-controlled trial in 176 Korean subjects. Int J Gynecol Cancer. 2008 Sep-Oct;18(5):1013-9. doi: 10.1111/j.1525-1438.2007.01123.x. Epub 2007 Nov 6. PMID 17986242
- DERIVEDHurt L, Nsouli-Maktabi H, Rohrbeck P, Clark LL. Use of quadrivalent human papillomavirus vaccine and the prevalence of antibodies to vaccine-targeted strains among female service members before and after vaccination. MSMR. 2016 Feb;23(2):6-13. PMID 26930146