WithdrawnNCT07224477Updated Sep 14, 2026

A Clinical Study of V540A in Healthy Female Participants (V540A-005)

A Phase 2 interventional study of V540A-2 and V540A-3 in Healthy, sponsored by Merck Sharp & Dohme LLC. Withdrawn. Open to female participants aged 16 Years to 26 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by Merck Sharp & Dohme LLC · Phase 2, Interventional, and Prevention

Why this study was withdrawn

Business Reasons

Phase: Phase 2
Study type: Interventional
Enrollment: 0
Allocation: Randomized
Ages: 16 Years to 26 Years
Sex: Female

Study summary

Researchers are looking for new ways to prevent cancers related to human papillomavirus (HPV). HPV is a common virus that can cause an infection. There are many different types of HPV.

A standard vaccine to prevent HPV-related cancers is V503. V503 protects against 9 types of HPV. V540A is a study vaccine designed to protect against the same (shared) 9 HPV types plus other (unique) HPV types.

Researchers want to learn if V540A:

Is safe and if people tolerate it
Works as well as V503 to cause an immune response (the body's response to protect against infections and illnesses) to the shared HPV types.

Conditions studied

Healthy

In context

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 16 Years to 26 Years
Sexes eligible: Female
Accepts healthy volunteers: Yes

Inclusion criteria

The main inclusion criteria include but are not limited to the following:

Is in good health
Has a lifetime history of 0 to 4 sexual partners of any sex/gender
A participant assigned female sex at birth is eligible to participate if not breastfeeding during the study intervention period and for at least 30 days after the last dose of study intervention

Exclusion criteria

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

Has a history of severe allergic reaction (e.g., swelling of the mouth and throat, difficulty breathing, hypotension, or shock) that required medical intervention
Has known or history of functional or anatomic asplenia
Is currently immunocompromised or has been diagnosed as having congenital or acquired immunodeficiency, human immunodeficiency virus infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition
Has thrombocytopenia or other coagulation disorder
Has had a positive test for human papillomavirus (HPV)
Has a history of recurrent respiratory papillomatosis or HPV-related head and neck cancer, or HPV-related anal lesions or anal cancer
Has a history of an abnormal cervical biopsy result
Has a history of HPV-related external genital lesions or external genital cancer, HPV-related vaginal lesions or vaginal cancer
Has received a dose of any HPV vaccine before study entry
Has received within 12 months before the Day 1 vaccination, is receiving, or plans to receive during the study, immunosuppressive therapies or other therapy known to interfere with the immune response
Is currently receiving systemic steroid therapy or has received 2 or more courses of high-dose corticosteroids lasting at least 1 week in duration in the year prior to Day 1 vaccination
Has received within the 3 months before the Day 1 vaccination, is receiving, or plans to receive during the study any immune globulin product

Study design

Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 0 participants (actual)

Study arms

Experimental
V540A-2
Participants will receive vaccinations of V540A-2.
Biological: V540A-2
Experimental
V540A-3
Participants will receive vaccinations of V540A-3.
Biological: V540A-3
Active comparator
GARDASIL®9
Participants will receive vaccinations of V503.
Biological: GARDASIL®9

Interventions

BiologicalV540A-2
Suspension administered via intramuscular (IM) injection.
BiologicalV540A-3
Suspension administered via intramuscular (IM) injection.
BiologicalGARDASIL®9
Suspension administered via IM injection.
Also known as: G9, SILGARD®9, V503

What researchers measure

Primary outcomes

Number of Participants Who Experience ≥1 Solicited Injection-site Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs include redness (erythema), swelling (swelling), and pain or tenderness (pain). The number of participants who experienced at least 1 solicited injection-site AE from Day 1 through Day 5 post each vaccination will be reported.
Time frame: Up to approximately 7 months
Number of Participants Who Experience ≥1 Solicited Pyrexia AE
Pyrexia is defined as a temperature(s) ≥100.4°F (≥38.0°C). The number of participants with solicited pyrexia from Day 1 through Day 5 post each vaccination will be reported.
Time frame: Up to approximately 7 months
Number of Participants Who Experience ≥1 Vaccine-related Serious AE (SAE)
A vaccine-related SAE is any untoward medical consequence that results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event which is determined by the investigator to be related to the vaccine. The number of participants who experienced at least 1 vaccine-related SAE will be reported.
Time frame: Up to approximately 7 months
Geometric Mean Titers (GMTs) to Each of the Shared Human Papillomavirus (HPV) Vaccine Types at Day 29 Postdose 3
Antibodies to HPV types shared between V540A and GARDASIL®9 will be measured. Geometric mean titers of antibodies to HPV types at Day 29 postdose 3 will be reported.
Time frame: Up to approximately 7 months

Secondary outcomes

GMTs of Each of the Shared and Unique HPV Vaccine Types at Day 29 Postdose 1
Antibodies to HPV types shared between V540A and GARDASIL®9 and unique to V540A will be measured. Geometric mean titers of antibodies to HPV types at Day 29 postdose 1 will be reported.
Time frame: Up to 29 days
GMTs of Each of the Shared and Unique HPV Vaccine Types at Day 29 Postdose 2
Antibodies to HPV types shared between V540A and GARDASIL®9 and unique to V540A will be measured. Geometric mean titers of antibodies to HPV types at Day 29 postdose 2 will be reported.
Time frame: Up to approximately 3 months
GMTs to Each of the Shared and Unique HPV Vaccine Types at Day 29 Postdose 3
Antibodies to HPV types shared between V540A and GARDASIL®9 and unique to V540A will be measured. Geometric mean titers of antibodies to HPV types at Day 29 postdose 3 will be reported.
Time frame: Up to approximately 7 months
Percentage of Participants with Seroconversion to Each of the Shared and Unique HPV Vaccine Types at Day 29 Postdose 1
Seroconversion is defined as changing a participant's serostatus from seronegative at Day 1 to seropositive by Day 29 postdose 1. The percentage of participants with seroconversion to each of the shared and unique HPV vaccine types at Day 29 postdose 1 will be reported.
Time frame: Up to approximately 2 months
Percentage of Participants with Seroconversion to Each of the Shared and Unique HPV Vaccine Types at Day 29 Postdose 2
Seroconversion is defined as changing a participant's serostatus from seronegative at Day 1 to seropositive by Day 29 postdose 2. The percentage of participants with seroconversion to each of the shared and unique HPV vaccine types at Day 29 postdose 2 will be reported.
Time frame: Up to approximately 3 months
Percentage of Participants with Seroconversion to Each of the Shared and Unique HPV Vaccine Types at Day 29 Postdose 3
Seroconversion is defined as changing a participant's serostatus from seronegative at Day 1 to seropositive by Day 29 postdose 3. The percentage of participants with seroconversion to each of the shared and unique HPV vaccine types at Day 29 postdose 3 will be reported.
Time frame: Up to approximately 7 months

Study locations

No study locations are listed for this record.

References and documents

Individual participant data

Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07224477
Lead sponsor: Merck Sharp & Dohme LLC
Responsible party: Sponsor
First posted: Nov 4, 2025
Start date: Jul 20, 2026 (estimated)
Primary completion: Apr 4, 2028 (estimated)
Completion: Apr 4, 2028 (estimated)
Last update: Sep 14, 2026

Study contacts

Medical Director

study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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