Phase 2
Completed N=107
V501 Immunogenicity Study in Females Age 9 to 17 Years (V501-028)
HPV Infections
Source: ClinicalTrials.gov NCT00411749 ↗
Enrolled (actual)
107
Serious AEs
1.9%
Results posted
Aug 2010
Primary outcomePrimary: Human Papilloma Virus (HPV) 6 Serum Antibody Titer at One Month After Completed Vaccination Series — 674.5; 7.0 Geometric Mean Titers (mMU/mL) — p=<0.001
Summary
The study evaluates the immunogenicity, safety and tolerability of V501 in preadolescent females
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Human Papilloma Virus (HPV) 6 Serum Antibody Titer at One Month After Completed Vaccination Series |
674.5; 7.0 | <0.001 sig |
| PRIMARY Human Papilloma Virus (HPV) 11 Serum Antibody Titer at One Month After Completed Vaccination Series |
944.5; 8.0 | <0.001 sig |
| PRIMARY Human Papilloma Virus (HPV) 16 Serum Antibody Titer at One Month After Completed Vaccination Series |
4275.4; 11.0 | <0.001 sig |
| PRIMARY Human Papilloma Virus (HPV) 18 Serum Antibody Titer at One Month After Completed Vaccination Series |
829.2; 10.0 | <0.001 sig |
| SECONDARY HPV 6, 11, 16 and 18 Serum Antibody Titer at 24 Month After Completed Vaccination Series |
155.2; 198.2; 617.1; 90.0 | — |
Eligibility Criteria
Inclusion Criteria
- Virginal Female Subject Aged 9 To 17 Years
Exclusion Criteria
- Male Subject
Data sourced from ClinicalTrials.gov (NCT00411749). 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.