A Phase 4 interventional study of Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed and Recombinant Human Papillomavirus Nonavalent Vaccine in Human Papillomavirus Infection and Human Papillomavirus-Related Malignant Neoplasm, sponsored by National Cancer Institute (NCI). Enrolling by invitation at 1 site in Costa Rica. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by National Cancer Institute (NCI) · Phase 4, Interventional, and Prevention
Among 31 studies testing Human Papillomavirus Recombinant Vaccine nonavalent in Papillomavirus Infections — 10 open to participants now, 20 under way, 8 of them phase 3. Human Papillomavirus Recombinant Vaccine nonavalent · Papillomavirus Infections.
Among the 31 studies testing Human Papillomavirus Recombinant Vaccine nonavalent in Papillomavirus Infections, this one is the 3rd largest by planned enrollment, is one of 4 that started in 2026, is one of 10 in phase 4, reaches primary completion later than 19 of the 19 other live ones, and was the 30th registered.
576 studies on the registry are indexed under Papillomavirus Infections; 132 are open to participants now.
Browse Papillomavirus Infections studies →10 of the 31 studies testing Human Papillomavirus Recombinant Vaccine nonavalent in Papillomavirus Infections are open now, in 9 countries. Recruiting first, the newest first:
Merck Sharp & Dohme LLC · Sites in China
Ages 10–45 · Women only · Healthy volunteers
Indiana University · Sites in Kenya
Ages 9–49 · Women only · Healthy volunteers
Western Institute for Veterans Research · Sites in United States
Ages 18+
Talia Sainz Costa · Sites in Spain
Ages 9–18 · Healthy volunteers
Louisiana State University Health Sciences Center in New Orleans · Sites in United States
Ages 18–65 · Healthy volunteers
By country, each count listing its studies:
Human Papillomavirus Recombinant Vaccine nonavalent: first FDA approval 2014 (Gardasil 9). What it is approved for, and how studies give it, is on its page →
Of the 85 Papillomavirus Infections studies recruiting now, 38 (45%) set no upper age limit and 42 (49%) stop at 75 or younger; 19 take children under 18; 36 take healthy volunteers.
This study: 18 Years and older · female · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
31 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 4 · Phase 3 17 · Phase 4 10
First in 2009; this study’s year is marked. 4 started in 2026.
This study's planned enrollment of 13,700 is above the median of 235 across 402 interventional studies indexed under Papillomavirus Infections.
Median enrollment 700 across the 31 interventional studies. Of the 11 that completed or were terminated, 11 (100%) have results posted.
This tab as a report to print or save as PDF → With an account.
16 of 31 have an industry lead sponsor. The 10 most frequent:
National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.
Of its 412 completed or terminated interventional studies of FDA-regulated products, 374 (91%) have results posted.
20 studies in Papillomavirus Infections by National Cancer Institute (NCI): 3 open now, 11 under way, none of them phase 3. Of 8 finished, 6 (75%) have results posted.
Among the 20 studies in Papillomavirus Infections by National Cancer Institute (NCI), this one is the 2nd largest by planned enrollment of the 17 interventional ones that give a count, is one of 2 that started in 2026, is one of 2 in phase 4, reaches primary completion later than 10 of the 10 other live ones, and was the 19th registered.
National Cancer Institute (NCI)’s Papillomavirus Infections studies by the year they started, since 2004.
3 of the studies testing Human Papillomavirus Recombinant Vaccine nonavalent in Papillomavirus Infections that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04199689Phase 3Merck Sharp & Dohme LLCEfficacy Against Oral Persistent Infection, Immunogenicity and Safety of the 9-valent Human Papillomavirus Vaccine (9vHPV) in Men Aged 20-45 Years (V503-049) | 2027-01-15 |
| NCT04206813Boston Medical CenterAn Exploratory Open-Label Clinical Trial Evaluating the Immunogenicity of the 9-valent 2-dose HPV Vaccination Regimen | 2026-12 |
| NCT07303751Institut d'Investigació Biomèdica de BellvitgeStudy Assessing Reduced HPV Infectivity and Transmission in HPV-Positive Women Following Vaccination With 9vHPV | 2027-02-01 |
Add all 3 to your calendar (.ics) → With an account.
Among the 31 studies testing Human Papillomavirus Recombinant Vaccine nonavalent in Papillomavirus Infections, from their registry updates:
Among National Cancer Institute (NCI)’s 20 in Papillomavirus Infections:
Nothing recorded among them since 2026-09-25.
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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.
PRIMARY OBJECTIVES:
I. To estimate the Incidence Rate Difference (IRD) and Relative Risk (RR) of incident HPV 6/11/16/18/31/33/45/52/58-related 6-months cervicovaginal persistent infection between recipients of single dose and 2 doses of 9vHPV vaccine, 7 to 10 years following HPV vaccination.
II. To estimate the IRD and RR of incident HPV 6/11/16/18/31/33/45/52/58-related 6-months cervicovaginal persistent infection between recipients of single dose and 2 doses of 9vHPV vaccine, 1 to 10 years following HPV vaccination.
OUTLINE: This is an interventional study. Participants are assigned to 1 of 3 arms.
Arm I (ONE DOSE GARDASIL9): Participants undergo cervicovaginal and anal swab self sample collection, blood sample collection, and complete questionnaires on study.
Arm II (TWO DOSE GARDASIL9): Participants undergo cervicovaginal and anal swab self sample collection, blood sample collection, and complete questionnaires on study.
Arm III (UNVACCINATED): Participants undergo cervicovaginal and anal swab self sample collection, blood sample collection, and complete questionnaires on study. These women will be offered HPV vaccination (Gardasil9).
Trial participants with documented persistent type-specific HPV infections will be triaged to colposcopy and may undergo biopsy collection and treatment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ONE DOSE GARDASIL9: Participants undergo cervicovaginal and anal swab self sample collection, blood sample collection, and complete questionnaires on study.
Biological: Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed · Biological: Recombinant Human Papillomavirus Nonavalent Vaccine
TWO DOSE GARDASIL9: Participants undergo cervicovaginal and anal swab self sample collection, blood sample collection, and complete questionnaires on study.
Biological: Recombinant Human Papillomavirus Nonavalent Vaccine
UNVACCINATED: Participants undergo cervicovaginal and anal swab self sample collection, blood sample collection, and complete questionnaires on study. These women will be offered HPV vaccination (Gardasil9).
Given IM in ESCUDDO (NCT03180034)
Also known as: Adacel, Daptacel, Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Diphtheria Toxoid Tetanus Toxoid Acellular Pertussis Vaccine Adsorbed, Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine, DTaP, Infanrix, Tripedia
Given intramuscularly (IM) in ESCUDDO (NCT03180034)
Also known as: Gardasil 9, Nonavalent HPV VLP Vaccine, Recombinant HPV Nonavalent Vaccine, Recombinant Human Papillomavirus 9-valent Vaccine
Comparison of incident persistent human papillomavirus (HPV) infection related to vaccine types observed during long-term follow-up study (LFTU) and the combined ESCUDDO base and LTFU studies; in recipients of single dose and 2 doses of the 9vHPV vaccine
Estimate the incidence rate difference and relative risk of first type-specific 6 month cervicovaginal persistent infection related to any of the nine vaccine HPV types (HPV 6/11/16/18/31/33/45/52/58) between recipients of 1 dose and 2 doses of Gardasil9. Study measures include self-collected cervicovaginal swabs collected every 6 months, HPV genotyping using the TypeSeq2 assay, identification of type-specific persistent infection based on two positive samples collected ≥3 months apart, and calculation of incidence rates in the Per-Protocol Efficacy (PPE) population.
Time frame: 7 to 10 years after first HPV vaccination
Comparison of cumulative persistent HPV infection (Base Study + LTFU)
Estimate the incidence rate difference and relative risk of first any-type 6 month cervicovaginal persistent infection related to any of the nine vaccine HPV types (HPV 6/11/16/18/31/33/45/52/58) between recipients of 1 dose versus 2 doses of Gardasil9 over the combined study period. Study measures include serial self-collected cervicovaginal swabs obtained from Year 1 through Year 10, HPV testing using the TypeSeq2 assay, determination of persistent infection from repeated HPV-positive results, and longitudinal follow-up to capture first occurrence of infection with any vaccine HPV type.
Time frame: 1 to 10 years after first HPV vaccination
Vaccine efficacy against multiple cervical endpoints, anal HPV prevalence, immunogenicity, and histologic endpoints
Estimate the vaccine efficacy of 1 dose and 2 doses of Gardasil9 against 6 month cervicovaginal persistent infection related to HPV 6/11/16/18/31/33/45/52/58 by comparing vaccinated participants with an unvaccinated epidemiology survey cohort. Study measures include self-collected cervicovaginal samples obtained at the 9.5- and 10-year visits, HPV genotyping using the TypeSeq2 assay, identification of persistent infections present at both visits, and comparison of infection prevalence in vaccinated participants versus approximately 4,000 unvaccinated women enrolled in the Epidemiologic HPV Survey.
Time frame: 9.5 to 10 years after first HPV vaccination
Comparison of high-grade cervical disease
Estimate the incidence rate difference and relative risk of HPV 16/18/31/33/45/52/58-related high-grade cervical disease (CIN2 or worse) between recipients of 1 dose and 2 doses of Gardasil9. Study measures include HPV screening results from cervicovaginal swabs, referral to cytology and colposcopy through protocol-defined triage algorithms, collection of cervical biopsies and excisional specimens, pathology panel review, and HPV genotyping of tissue specimens to confirm HPV-associated CIN2, CIN3, adenocarcinoma in situ (AIS), or cervical cancer.
Time frame: 7 to 10 years after first HPV vaccination
Long-term immunogenicity assessment
Evaluate the peak and persistence of antibody responses (geometric mean concentrations and seropositivity rates) to all nine vaccine HPV types (HPV 6/11/16/18/31/33/45/52/58) following 1-dose and 2-dose vaccination regimens. Study measures include serum samples collected at enrollment and annual follow-up visits, laboratory assessment of HPV-specific antibody concentrations using the NCI IgG Luminex Immunoassay (LIA), calculation of geometric mean concentrations (GMCs), and determination of seropositivity rates for each vaccine HPV type. Additional annual blood collections in the Immunogenicity Subgroup (ISG) support detailed analyses of immune response durability. The ISG is a subset of approximately 700 Gardasil 9 participants (about 350 per dose arm) from ESCUDDO who consent to continue in the subgroup during LTFU.
Time frame: Up to 10 years after vaccination, with measurements during LTFU annual visits
Started Aug 2026 (actual). Primary completion is estimated for Oct 2030, 49 months after the start.
Of 28 phase 4 interventional studies under Papillomavirus Infections, half reached primary completion within 62 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 92. This study's planned 49 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Human Papillomavirus Recombinant Vaccine nonavalent
National Cancer Institute (NCI) →