Phase 3
N=176
Human Papillomavirus (HPV) Registration Study (Gardasil)(V501-023)(COMPLETED)
Papillomavirus Infections
Bottom Line
View on ClinicalTrials.gov: NCT00157950 ↗Enrolled (actual)
176
Serious AEs
1.1%
Results posted
Sep 2010
Primary outcome: Primary: Number of Participants Who Seroconvert to HPV 6. — 109; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Gardasil™ (Biological); Placebo (Biological)
- Age
- Pediatric, Adult · 9+ yrs
- Sex
- Female
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Jun 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Seroconvert to HPV 6. |
109; 0 | — |
| PRIMARY Number of Participants Who Seroconvert to HPV 11. |
112; 1 | — |
| PRIMARY Number of Participants Who Seroconvert to HPV 16. |
112; 0 | — |
| PRIMARY Number of Participants Who Seroconvert to HPV 18. |
109; 0 | — |
| SECONDARY Number of Participants With Adverse Experiences |
0; 0; 0; 0; 0; 0 | — |
Summary
This is an immunogenicity and safety study of Gardasil (V501) in females 9 to 23 years of age in Korea.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00157950). 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.