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Papillomavirus InfectionsPhase 3NCT05450705

V503 in Chinese Girls 9-14 Years Old Versus Chinese Women 20-26 Years Old (V503-071)

A Phase 3 study testing 9vHPV vaccine in people with Papillomavirus Infections, run by Merck Sharp & Dohme LLC at 2 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 aims to demonstrate that a 2-dose regimen of the 9-Valent Human Papillomavirus (9vHPV) vaccine (GARDASIL™9, V503) induces non-inferior competitive Luminex immunoassay (cLIA) geometric mean titers (GMTs) to each of the 9vHPV vaccine types in Chinese girls 9 through 14 years of age compared to a 3-dose… Read more about this study

Who is it for?
Ages 9 to 26 years, women onlyHealthy volunteers can take part
Conditions the study is for
Papillomavirus Infections
What is being tested?
9vHPV vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,500 participants
Where
2 sitesChina
Study dates
22 Jul 2022to 3 Aug 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 26 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Is a healthy Chinese female.
  • Is not a woman of childbearing potential (WOCBP); or is a WOCBP who has not had sex with males or has had sex with males and used effective contraception during Day 1 through 1 month post last dose.

Who cannot join

  • Has a history of known prior vaccination with an HPV vaccine.
  • Has a history of severe allergic reaction that required medical intervention.
  • Has a known thrombocytopenia or coagulation disorder that would contraindicate IM injections.
  • Has a history of abnormal Pap test or external genital wart, vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, anal intraepithelial neoplasia, vulvar cancer, vaginal cancer, or anal cancer.
  • Has a history of a positive test for HPV.
  • 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, 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.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Jiangshan Center for Disease Control and Prevention ( Site 0001)

    Quzhou, Zhejiang, 324100

  • Yuhuan Center for Disease Control and Prevention ( Site 0002)

    Taizhou, Zhejiang, 317600

Other trials in China

About this study

Official title: A Phase 3 Open-Label Immunogenicity and Safety Study of 2-Dose Regimens of a 9vHPV Vaccine (V503) in Chinese Girls 9 Through 14 Years of Age With a Comparison to 3-Dose Regimen of V503 in Chinese Women 20 Through 26 Years of Age

This study aims to demonstrate that a 2-dose regimen of the 9-Valent Human Papillomavirus (9vHPV) vaccine (GARDASIL™9, V503) induces non-inferior competitive Luminex immunoassay (cLIA) geometric mean titers (GMTs) to each of the 9vHPV vaccine types in Chinese girls 9 through 14 years of age compared to a 3-dose regimen in Chinese women 20 through 26 years of age. The primary hypothesis is that a 2-dose regimen has a non-inferiority margin of 0.67 in the GMT ratio (girls vs. women) for each HPV type.

Being tested
9vHPV vaccine
Medical subject headings
Papillomavirus Infections

What participants receive

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

  • 9vHPV vaccineBiological

    Also called V503, GARDASIL9™

    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 NCT05450705
Study groupRoleWhat they receive
9 to 14 Years Old: Day 1 and Month 6ExperimentalChinese females 9 to 14 years old will receive a 0.5 mL intramuscular (IM) injection of 9-valent HPV (9vHPV) vaccine on Day 1 and Month 6
Receives: Biological: 9vHPV vaccine
9 to 14 Years Old: Day 1 and Month 12ExperimentalChinese females 9 to 14 years old will receive a 0.5 mL iIM injection of 9-valent HPV (9vHPV) vaccine on Day 1 and Month 12
Receives: Biological: 9vHPV vaccine
20 to 26 Years Old: Day 1, Month 2 and Month 6ExperimentalChinese females 20 to 26 years old will receive a 0.5 mL IM injection of 9-valent HPV (9vHPV) vaccine on Day 1, Month 2 and Month 6
Receives: Biological: 9vHPV vaccine

What is being measured

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

  1. Stage I: Competitive Luminex immunoassay (cLIA) Geometric Mean Titers (GMTs) to 9 vaccine types of 9vHPV vaccine

    cLIA GMT to each of 9 vaccine types of 9vHPV vaccine. The GMT for each HPV type will be reported in mMU/mL.

    Measured: One month after last dose (Up to Month 13)

  2. Stage II: cLIA GMTs to 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age

    cLIA GMT to each of 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age. The GMT for each HPV type will be reported in mMU/mL.

    Measured: Up to Month 84

  3. Stage II: cLIA seropositivity percentages to 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age

    cLIA seropositivity to each of 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age. The percentage of participants who are seropositive for each HPV type will be summarized.

    Measured: Up to Month 84

Secondary outcomes (9)

  1. Stage I: 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: One month after last dose (Up to Month 13)

  2. Stage I: 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: One month after last dose (Up to Month 13)

  3. Stage I: 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: One month after last dose (Up to Month 13)

  4. Stage I: 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. Stage I: 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. Stage I: Percentage of participants experiencing serious AEs (SAEs) Up to Month 13

    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 Month 13

  7. Stage II: Percentage of participants experiencing SAEs Up to Month 84

    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: Month 18 up to Month 84

  8. Stage II: IgG LIA GMTs to 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age

    IgG LIA GMT to each of 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age. The GMT for each HPV type will be reported in mMU/mL.

    Measured: Up to Month 84

  9. Stage II: IgG LIA seropositivity percentages to 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age

    IgG LIA seropositivity to each of 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age. The percentage of participants who are seropositive for each HPV type will be summarized

    Measured: Up to Month 84

Timeline

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

  1. First posted11 Jul 2022
  2. Study start22 Jul 2022
  3. Primary completion3 Aug 2029 (estimated)
  4. Study completion3 Aug 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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05450705
Sponsor's protocol ID
V503-071
Other IDs
V503-071
Status last verified
Sep 2022
First submitted
28 Jun 2022
Last updated
2 Sep 2022
Results posted
No
Data monitoring committee
No
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 Papillomavirus Infections, run by Merck Sharp & Dohme LLC at 2 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 8 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 2 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

Stage I: Competitive Luminex immunoassay (cLIA) Geometric Mean Titers (GMTs) to 9 vaccine types of 9vHPV vaccine (time frame: One month after last dose (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 NCT05450705.

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 2 Sep 2022.

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