Clinical trial · Interventional
Immunogenicity of Fractional Dose of the HPV Vaccines
NCT05291871CI-TRIAL-00110424active not recruitingPhase 4ClinicalTrials.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 randomized phase IV trial compares intramuscular and intradermal fractional dose of bivalent HPV vaccine to fractional dose of nonavalent HPV vaccine among men and women aged 27-45 years in Seattle, Washington. Participants will have immune response assessed at baseline, 4 weeks, 6 months, and 12 months
Conditions
Conditions (2)
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 Infection | — | UNRESOLVED | — |
| HPV Vaccine | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HPV vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- IM Bivalent HPV vaccine
- description
- One-fifth fractional dose (0.1 ml) of bivalent HPV vaccine administered intramuscularly
- interventionNames
- Biological: HPV vaccine
- type
- EXPERIMENTAL
- label
- ID Bivalent HPV vaccine
- description
- One-fifth fractional dose (0.1 ml) of bivalent HPV vaccine administered subcutaneously
- interventionNames
- Biological: HPV vaccine
- type
- EXPERIMENTAL
- label
- IM Nonavalent HPV vaccine
- description
- One-fifth fractional dose (0.1 ml) of nonavalent HPV vaccine administered intramuscularly
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 27 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Age 27-45 years at enrollment * Not intending to receive the HPV vaccine series for the duration of the study participation * Willing and able to: provide written informed consent, undergo clinical evaluation, adhere to follow-up schedule Exclusion Criteria: * Prior immunization with HPV-vaccine (Cervarix, Gardasil-4, Gardasil-9) * Currently pregnant or breastfeeding * Immunedeficiency disease/condition or cancer that causes clinically significant immunosuppression * Known HIV infection * Chemotherapy (current or within 12 months) or currently taking a medication that causes clinically significant immunosuppression. * Unstable medical condition (e.g., malignant hypertension, poorly controlled diabetes) * Known allergy to vaccine components * Prior history of HPV-associated cancer * Any medical condition which, in the opinion of the investigator, may compromise the subject's ability to safely complete the study.
References
Publications (0)
Data not yet available
No reference posted for this study.