Clinical trial · Interventional
Broad Spectrum HPV (Human Papillomavirus) Vaccine in 16 to 26 Year Old Women (V505-001)
A Phase IIa Randomized, Double-Blind Controlled With Gardasil, Clinical Trial to Study theTolerability and Immunogenicity of V505 (a Multivalent Human Papilloma Virus [HPV] L1 Virus Like Particle [VLP] Vaccine) in Healthy 16 to 26 Year Old Women
NCT00520598CI-TRIAL-00019947completedPhase 2ClinicalTrials.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 purpose of this study is to evaluate the safety and immunogenicity of V505 in comparison to GARDASIL (TM)
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Genital Warts | Condyloma Acuminatum | ALIAS | 0.90 |
| Human Papillomavirus Infection | — | UNRESOLVED | — |
| Vaginal Cancer | Malignant Vaginal Neoplasm | CURATED_EXACT | 0.92 |
| Vulvar Cancer | Malignant Vulvar Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Comparator: Placebo (unspecified) | Biological | — | UNRESOLVED |
| Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant | Biological | — | UNRESOLVED |
| Comparator: V505 formulation 1 | Biological | — | UNRESOLVED |
| Comparator: V505 formulation 2 | Drug | — | UNRESOLVED |
| Comparator: V505 formulation 3 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Arm 1: 0.5 ml injection of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine as 3 dose regimen.
- interventionNames
- Biological: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant
- type
- EXPERIMENTAL
- label
- 2
- description
- Arm 2: 0.5 ml injection of V505 formulation 1 as 3 dose regimen.
- interventionNames
- Biological: Comparator: V505 formulation 1
- type
- EXPERIMENTAL
- label
- 3
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 16 Years
- Maximum age
- 26 Years
Show eligibility criteria text
Inclusion Criteria: * Female between 16 to 26 years old * Has never had Pap testing or have only had normal Pap test results * Lifetime history of 0 to 4 sexual partners Exclusion Criteria: * History of an abnormal cervical biopsy result; History of a positive test for HPV; History of external genital/vaginal warts; Currently a user of any illegal drugs or an alcohol abuser * History of severe allergic reaction that required medical attention * Are pregnant * Received a marketed HPV vaccine * Currently enrolled in a clinical trial * Currently has (or has a history of) certain medical conditions or is currently taking or has taken certain medications (details will be discussed at time of consent)
References
Publications (1)
- DERIVEDBergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2. PMID 41276263