Clinical trial · Interventional
V501 Immunogenicity Study in Females Age 9 to 17 Years (V501-028)
V501 Phase II Immunogenicity Study in Females Aged 9 to 17 Years
NCT00411749CI-TRIAL-00027133completedPhase 2Results 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)
The study evaluates the immunogenicity, safety and tolerability of V501 in preadolescent females
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 |
|---|---|---|---|
| HPV Infections | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Comparator: Placebo (unspecified) | Biological | — | UNRESOLVED |
| Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- V501
- description
- V501 vaccination Quadrivalent HPV (Types 6, 11, 16, 18\) L1 VLP Vaccine Injection cervix cancer exgenlesion Vaccination at Day 1, Month 2, and Month 6. Total 3 vaccinations. 0.5 mL intramuscular dose of V501 (HPV L1 Virus-Like Particle \[VLP\] Type 6, Type 11, Type 16, Type 18) or placebo at Day 1, Month 2 and Month 6.
- interventionNames
- Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo vaccination, Placebo 0.5 ml injection in 3 dosing regimen
- interventionNames
- Biological: Comparator: Placebo (unspecified)
Primary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 9 Years
- Maximum age
- 17 Years
Show eligibility criteria text
Inclusion Criteria: * Virginal Female Subject Aged 9 To 17 Years Exclusion Criteria: * Male Subject
References
Publications (1)
- DERIVEDMurata S, Shirakawa M, Sugawara Y, Shuto M, Sawata M, Tanaka Y. Post-hoc analysis of injection-site reactions following vaccination with quadrivalent human papillomavirus vaccine in Japanese female clinical trial participants. Papillomavirus Res. 2020 Dec;10:100205. doi: 10.1016/j.pvr.2020.100205. Epub 2020 Aug 19. PMID 32827835