Clinical trial · Interventional
ESCUDDO Long Term Follow Up
A Scientific Evaluation of One or Two Doses of a Vaccine Against Human Papillomavirus: Long Term Follow Up of Gardasil9 Recipients in the ESCUDDO Study ("Estudio de Comparación de Una y Dos Dosis de Vacunas Contra el Virus de Papiloma Humano (VPH)")
NCT07706673CI-TRIAL-00124995ESCUDDO LTFUenrolling by invitationPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
This phase IV trial evaluates the long term protection provided by either one or two doses of the 9v human papillomavirus (HPV) vaccine for participants who were part of the ESCUDDO study.
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 |
|---|---|---|---|
| Human Papillomavirus Infection | — | UNRESOLVED | — |
| Human Papillomavirus-Related Malignant Neoplasm | Human Papillomavirus-Related Malignant Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed | Biological | — | UNRESOLVED |
| Recombinant Human Papillomavirus Nonavalent Vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm I (Gardasil, Tdap)
- description
- ONE DOSE GARDASIL9: Participants undergo cervicovaginal and anal swab self sample collection, blood sample collection, and complete questionnaires on study.
- interventionNames
- Biological: Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed
- Biological: Recombinant Human Papillomavirus Nonavalent Vaccine
- type
- ACTIVE_COMPARATOR
- label
- Arm II (2 Doses Gardasil)
- description
- TWO DOSE GARDASIL9: Participants undergo cervicovaginal and anal swab self sample collection, blood sample collection, and complete questionnaires on study.
- interventionNames
- Biological: Recombinant Human Papillomavirus Nonavalent Vaccine
- type
- NO_INTERVENTION
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * TRIAL PARTICIPANTS: Participation in ESCUDDO base study * TRIAL PARTICIPANTS: Randomization (excluding the two participants who had major protocol deviations in the ESCUDDO base study) to the Gardasil9 1- and 2-dose arms * TRIAL PARTICIPANTS: A signed informed consent form for ESCUDDO LTFU * TRIAL PARTICIPANTS: Opportunity to complete three total study visits * LTFU SURVEY GROUP: We will match the current ages of ESCUDDO LTFU trial participants when they attend their 9.5-year study visit (21 to 26 years of age) Exclusion Criteria: * TRIAL PARTICIPANTS: Enrollment cannot occur beyond her 10 year study visit * LTFU SURVEY GROUP: They report they are pregnant * LTFU SURVEY GROUP: They report being vaccinated against HPV * LTFU SURVEY GROUP: The qualified healthcare personnel determining eligibility, in agreement with principal investigator, considers a reason that precludes participation; or * LTFU SURVEY GROUP: They do not have an identification document
References
Publications (0)
Data not yet available
No reference posted for this study.