HealthyPhase 2NCT07224477
A Clinical Study of V540A in Healthy Female Participants (V540A-005)
A Phase 2 study testing V540A-2, V540A-3 and GARDASIL®9 in people with Healthy, run by Merck Sharp & Dohme LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 26 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- V540A-2, V540A-3 and GARDASIL®9
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2026to 4 Apr 2028
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 26 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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
About this study
Official title: A Phase 2, Randomized, Double-Blind, Comparator-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V540A in Healthy Females 16 to 26 Years of Age
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
- Healthy
- Being tested
- V540A-2, V540A-3, GARDASIL®9
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V540A-2Biological
Suspension administered via intramuscular (IM) injection.
V540A-3Biological
Suspension administered via intramuscular (IM) injection.
GARDASIL®9Biological
Also called G9, SILGARD®9, V503
Suspension administered via IM injection.
| Study group | Role | What they receive |
|---|---|---|
| V540A-2 | Experimental | Participants will receive vaccinations of V540A-2. Receives: Biological: V540A-2 |
| V540A-3 | Experimental | Participants will receive vaccinations of V540A-3. Receives: Biological: V540A-3 |
| GARDASIL®9 | Active comparator | Participants will receive vaccinations of V503. Receives: Biological: GARDASIL®9 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to approximately 7 months
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to approximately 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2025
- Study start20 Jul 2026 (estimated)
- Primary completion4 Apr 2028 (estimated)
- Study completion4 Apr 2028 (estimated)
Why it stopped: Business Reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07224477
- Sponsor's protocol ID
- V540A-005
- Other IDs
- U1111-1314-2250, 2024-518805-16-00
- Status last verified
- Sep 2026
- First submitted
- 3 Nov 2025
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Comparator-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V540A in Healthy Females 16 to 26 Years of Age
- ClinicalTrials.gov ID
- NCT07224477
- Acronym / sponsor ID
- V540A-005
- Conditions
- Healthy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business Reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2026 (estimated)
- Primary completion
- 4 Apr 2028 (estimated)
- Study completion
- 4 Apr 2028 (estimated)
- First posted
- 4 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| V540A-2 | Experimental | Biological: V540A-2Participants will receive vaccinations of V540A-2. |
| V540A-3 | Experimental | Biological: V540A-3Participants will receive vaccinations of V540A-3. |
| GARDASIL®9 | Active comparator | Biological: GARDASIL®9Participants will receive vaccinations of V503. |
Who may qualify
- Ages
- 16 to 26 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| V540A-2Suspension administered via intramuscular (IM) injection. | Biological | V540A-2 |
| V540A-3Suspension administered via intramuscular (IM) injection. | Biological | V540A-3 |
| GARDASIL®9Also: G9, SILGARD®9, V503Suspension administered via IM injection. | Biological | GARDASIL®9 |
Primary outcome
Number of Participants Who Experience ≥1 Solicited Injection-site Adverse Event (AE)
Time frame: Up to approximately 7 months
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.
Number of Participants Who Experience ≥1 Solicited Pyrexia AE
Time frame: Up to approximately 7 months
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.
Number of Participants Who Experience ≥1 Vaccine-related Serious AE (SAE)
Time frame: Up to approximately 7 months
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.
Geometric Mean Titers (GMTs) to Each of the Shared Human Papillomavirus (HPV) Vaccine Types at Day 29 Postdose 3
Time frame: Up to approximately 7 months
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.
6 secondary outcomes
GMTs of Each of the Shared and Unique HPV Vaccine Types at Day 29 Postdose 1
Time frame: Up to 29 days
GMTs of Each of the Shared and Unique HPV Vaccine Types at Day 29 Postdose 2
Time frame: Up to approximately 3 months
GMTs to Each of the Shared and Unique HPV Vaccine Types at Day 29 Postdose 3
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
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
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
Time frame: Up to approximately 7 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Plain Language Summary LinkLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing V540A-2, V540A-3 and GARDASIL®9 in people with Healthy, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experience ≥1 Solicited Injection-site Adverse Event (AE) (time frame: Up to approximately 7 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.