Clinical trial · Interventional
Broad Spectrum HPV Vaccine Dose Ranging Study (V502-001)
A Randomized, International, Double-Blinded (With In-House Blinding), GARDASIL-Controlled, Dose-Ranging Study of Octavalent Human Papillomavirus (HPV) L1 Virus-like Particle (VLP) Vaccine Administered to 16- to 23- Year-Old Women
NCT00260039CI-TRIAL-00018186completedPhase 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)
This dose-ranging study is to evaluate an investigational vaccine with the following objectives: (1) To demonstrate that the vaccine is well-tolerated in women (2) To evaluate immune responses in women who are between 16 and 23 years of age at enrollment.
Conditions
Conditions (3)
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 |
| HPV | — | UNRESOLVED | — |
| Premalignancy Anogenital Warts | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Comparator: Gardasil | Biological | — | UNRESOLVED |
| Comparator: octavalent HPV Vaccine - dose formulation 1 | Biological | — | UNRESOLVED |
| Comparator: octavalent HPV Vaccine - dose formulation 2 | Biological | — | UNRESOLVED |
| Comparator: octavalent HPV Vaccine - dose formulation 3 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Gardasil
- interventionNames
- Biological: Comparator: Gardasil
- type
- EXPERIMENTAL
- label
- 2
- description
- HPV VLP vaccine -Dose regimen 1
- interventionNames
- Biological: Comparator: octavalent HPV Vaccine - dose formulation 1
- type
- EXPERIMENTAL
- label
- 3
- description
- HPV VLP vaccine -Dose regimen 2
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 16 Years
- Maximum age
- 23 Years
Show eligibility criteria text
Inclusion Criteria: * Lifetime history of 0-4 sexual partners Exclusion Criteria: * History of abnormal PAP test or abnormal cervical biopsy result; history of external genital/vaginal warts; history of positive HPV test
References
Publications (1)
- BACKGROUNDLuxembourg A, Brown D, Bouchard C, Giuliano AR, Iversen OE, Joura EA, Penny ME, Restrepo JA, Romaguera J, Maansson R, Moeller E, Ritter M, Chen J. Phase II studies to select the formulation of a multivalent HPV L1 virus-like particle (VLP) vaccine. Hum Vaccin Immunother. 2015;11(6):1313-22. doi: 10.1080/21645515.2015.1012010. PMID 25912208