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Genital WartsPhase 3NCT05314023

Immunogenicity and Safety of V503 in Chinese Males 9 Through 19 Years Old (V503-053)

A Phase 3 study testing 9vHPV vaccine in people with Genital Warts, run by Merck Sharp & Dohme LLC at 5 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study is designed to demonstrate non-inferior immunogenicity of 3 doses of the 9-Valent Human Papillomavirus (9vHPV) vaccine (GARDASIL™9, V503) in Chinese males 9 through 19 years of age, and 2 doses of the 9vHPV vaccine in Chinese males 9 through 14 years of age, compared to the 3 dose regimen in Chinese males… Read more about this study

Who is it for?
Ages 9 to 19 years, men onlyHealthy volunteers can take part
Conditions the study is for
Genital Warts
What is being tested?
9vHPV vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,590 participants
Where
5 sitesChina
Study dates
7 May 2022to 19 Feb 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 9 to 19 years
  • Men only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Is a healthy Chinese male.
  • Has not had sexual debut at the time of enrollment, and does not plan on becoming sexually active during the vaccination period (Day 1 through one month post last dose).

Who cannot join

  • Has a history of known prior vaccination with an HPV vaccine.
  • Has a history of HPV-related external genital lesions, HPV-related intra-anal lesions, or HPV-related head and neck cancer.
  • Has a history of severe allergic reaction that required medical intervention.
  • Has received immune globulin or blood-derived products in the past 6 months or plans to receive any before one month post last dose.
  • Has a history of splenectomy, is currently immunocompromised, or has been diagnosed with immunodeficiency, human immunodeficiency virus (HIV), lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition.
  • Has received immunosuppressive therapy in the past year, excluding inhaled, nasal, or topical corticosteroids and certain regimens of systemic corticosteroids.
  • Has a known thrombocytopenia or coagulation disorder that would contraindicate IM injections.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

China5 sites

  • Yuechi Disease Prevention and Control Center ( Site 0002)

    Guang’an, Sichuan, 638399

  • Liucheng County Centers for Disease Control and Prevention ( Site 0005)

    Liuzhou, Guangxi, 545200

  • Center for Disease Control and Prevention of Rong An ( Site 0006)

    Liuzhou, Guangxi, 545400

  • Loudi Public Health Hospital (Loudi Occupational Disease Prevention And Treatment Hospital) ( Site 0

    Louxing District, Hunan, 417000

  • Santai County Center for Disease Control and Prevention ( Site 0001)

    Mianyang, Sichuan, 621100

Other trials in China

About this study

Official title: A Phase 3 Open-Label Immunogenicity and Safety Study of 2-Dose Regimens of V503, a 9-Valent Human Papillomavirus (HPV) Vaccine in Chinese Males 9 Through 14 Years Old and 3-Dose Regimen of V503 in Chinese Males 9 Through 19 Years Old

This study is designed to demonstrate non-inferior immunogenicity of 3 doses of the 9-Valent Human Papillomavirus (9vHPV) vaccine (GARDASIL™9, V503) in Chinese males 9 through 19 years of age, and 2 doses of the 9vHPV vaccine in Chinese males 9 through 14 years of age, compared to the 3 dose regimen in Chinese males 20 through 26 years of age (from Merck Protocol V503-052). The primary hypothesis is that each of the 3-dose regimen in Chinese males aged 9 through 19 years and 2-dose regimens in Chinese males aged 9 through 14 years induces non-inferior competitive Luminex immunoassay (cLIA) geometric mean titers (GMTs) at one month post last dose compared to the 3-dose regimen in Chinese adult males aged 20 through 26 years. A noninferiority margin of 0.67 in the GMT ratio (9 through 19 years of age or 9 through 14 years of age vs 20 through 26 years of age) is used for each HPV type.

Conditions
Genital Warts
Being tested
9vHPV vaccine
Medical subject headings
Condylomata Acuminata

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 9vHPV vaccineBiological

    Also called V503, GARDASIL™9

    A 9-valent HPV vaccine (Types 6, 11, 16, 18, 31, 33, 45, 52, and 58) will be administered as a 0.5 mL IM injection.

Study groups in NCT05314023
Study groupRoleWhat they receive
9 to 19 Years Old: Day 1, Months 2 and 6ExperimentalChinese males 9 to 19 years old will receive a 0.5 mL intramuscular (IM) injection of 9-valent HPV (9vHPV) vaccine on Day 1, Month 2 and Month 6
Receives: Biological: 9vHPV vaccine
9 to 14 Years Old: Day 1, and Month 6ExperimentalChinese males 9 to 14 years old will receive a 0.5 mL IM injection of 9vHPV vaccine on Day 1 and Month 6
Receives: Biological: 9vHPV vaccine
9 to 14 Years Old: Day 1 and Month 12ExperimentalChinese males 9 to 14 years old will receive a 0.5 mL IM injection of 9vHPV vaccine on Day 1 and Month 12
Receives: Biological: 9vHPV vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Competitive Luminex immunoassay (cLIA) GMTs to 9 vaccine types of 9vHPV vaccine at one month post last dose

    cLIA GMT to each of 9 vaccine types of 9vHPV vaccine at one month post last dose. The GMT for each HPV type will be reported in mMU/mL.

    Measured: Up to Month 13

  2. cLIA GMTs to 9 vaccine types of 9vHPV vaccine up to 60 months post last dose

    cLIA GMT to each of 9 vaccine types of 9vHPV vaccine at up to 60 months post last dose. The GMT for each HPV type will be reported in mMU/mL.

    Measured: Up to 72 months

  3. cLIA seropositivity percentages to 9 vaccine types of 9vHPV vaccine

    cLIA seropositivity to each of 9 vaccine types of 9vHPV vaccine. The percentage of participants who are seropositive for each HPV type will be summarized.

    Measured: Up to 72 months

Secondary outcomes (8)

  1. cLIA seroconversion percentages to 9 vaccine types of 9vHPV vaccine

    cLIA seroconversion to each of 9 vaccine types of 9vHPV vaccine. The percentage of participants who are seropositive for each HPV type will be summarized.

    Measured: Up to Month 13

  2. Immunoglobulin G Luminex immunoassay (IgG LIA) GMTs to 9 vaccine types of 9vHPV vaccine at one month post last dose

    IgG LIA GMT to each of 9 vaccine types of 9vHPV vaccine at one month post last dose. The GMT for each HPV type will be reported in mMU/mL.

    Measured: Up to Month 13

  3. IgG LIA seroconversion percentages to 9 vaccine types of 9vHPV vaccine

    IgG LIA seroconversion to each of 9 vaccine types of 9vHPV vaccine. The percentage of participants who are seropositive for each HPV type will be summarized.

    Measured: Up to Month 13

  4. Percentage of participants experiencing solicited injection-site adverse events (AEs),

    An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Solicited injection-site AEs such as erythema, swelling, pain, and induration at the injection site will be recorded.

    Measured: Day 1 through Day 8 following any study vaccination

  5. Percentage of participants experiencing solicited systemic AEs

    An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Systemic AEs are those not categorized as injection-site AEs.

    Measured: Day 1 through Day 8 following any study vaccination

  6. Percentage of participants experiencing serious AEs (SAEs)

    A SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event.

    Measured: Up to 72 months

  7. IgG LIA GMTs to 9 vaccine types of 9vHPV vaccine up to 60 months post last dose

    IgG LIA GMT to each of 9 vaccine types of 9vHPV vaccine up to 60 months post last dose. The GMT for each HPV type will be reported in mMU/mL.

    Measured: Up to 72 months

  8. IgG LIA seropositivity percentages to 9 vaccine types of 9vHPV vaccine

    IgG LIA seropositivity to each of 9 vaccine types of 9vHPV vaccine. The percentage of participants who are seropositive for each HPV type will be summarized.

    Measured: Up to 72 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2022
  2. Study start7 May 2022
  3. Primary completion19 Feb 2029 (estimated)
  4. Study completion19 Feb 2029 (estimated)

Resources

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 3
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,590 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05314023
Sponsor's protocol ID
V503-053
Other IDs
V503-053
Status last verified
Jan 2023
First submitted
29 Mar 2022
Last updated
19 Jan 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 9vHPV vaccine in people with Genital Warts, run by Merck Sharp & Dohme LLC at 5 sites in China.

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 2 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Competitive Luminex immunoassay (cLIA) GMTs to 9 vaccine types of 9vHPV vaccine at one month post last dose (time frame: Up to Month 13). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05314023.

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 19 Jan 2023.

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