Phase 2
Completed N=1,021
V501 Efficacy Study in Women Aged 18 to 26 (V501-027)
HPV Infections
Source: ClinicalTrials.gov NCT00378560 ↗
Enrolled (actual)
1,021
Serious AEs
11.0%
Results posted
Jun 2010
Primary outcomePrimary: Combined Incidence of Persistent Human Papillomavirus (HPV) 6, 11, 16 and 18 Infection or HPV 6, 11, 16 and 18 Related-Disease as Determined by Clinical/Pathologic Criteria and Positive Polymerase Chain Reaction (PCR) Assay for Virus Subtype — 0.4; 3.1 Incidence per 100 person-years
Summary
A study to evaluate the efficacy, immunogenicity, safety and tolerability of V501 in adult women
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Combined Incidence of Persistent Human Papillomavirus (HPV) 6, 11, 16 and 18 Infection or HPV 6, 11, 16 and 18 Related-Disease as Determined by Clinical/Pathologic Criteria and Positive Polymerase Chain Reaction (PCR) Assay for Virus Subtype |
0.4; 3.1 | — |
| SECONDARY Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 6) |
390.8; 7.0 | <0.001 sig |
| SECONDARY Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 11) |
579.8; 8.0 | <0.001 sig |
| SECONDARY Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 16) |
2396.4; 11.0 | <0.001 sig |
| SECONDARY Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 18) |
369.0; 10.0 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Female Subject Aged 18 To 26 Years
- With 1-4 Lifetime Sexual Partners
Exclusion Criteria
- Male Subject
Data sourced from ClinicalTrials.gov (NCT00378560). 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. Informational only — not medical advice.