Clinical Trials in China / NCT07785843
Recruiting
Phase 3
A Clinical Study of V503 in Chinese Females Who Have Previously Received a Bivalent Human Papillomavirus (HPV) Vaccine (V503-108)
NCT07785843 · tracked via the Priya Life Science China tracker
Condition(s) studied
Papillomavirus Infections
Investigational drug(s) / intervention(s)
V503 →Placebo
V503: V503 (9-vHPV vaccine \[Types 6, 11, 16, 18, 31, 33, 45, 52, and 58\]) administered as a 0.5-mL intramuscular (IM) injection on Day 1, Month 2, and Month 6
Placebo: Saline administered as a 0.5-mL IM injection on Day 1, Month 2, and Month 6
Study summary
Researchers want to learn if V503 (also called the 9-valent human papillomavirus \[9vHPV\] vaccine, recombinant) can induce an immune response to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Chinese females who previously received the bivalent HPV (2vHPV) vaccine.
The 9vHPV vaccine protects against diseases caused by 9 types of HPV (6, 11, 16, 18, 31, 33, 45, 52, and 58) and the 2vHPV vaccine protects against diseases caused by 2 types of HPV (16 and 18).
The goals of the trial are to learn:
* If the 9vHPV vaccine can induce an immune response to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in participants who received the 2vHPV vaccine
* About the safety of the 9vHPV vaccine in prior 2vHPV vaccine recipients
Eligibility
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
* For participants to be enrolled in prior 2vHPV (bivalent human papillomavirus \[HPV\] vaccine) vaccine groups: has received at least one dose of any one of the three currently marketed 2vHPV vaccines, with the last dose administered at least one year prior to Day 1.
* For participants to be enrolled in HPV vaccine naïve groups: has never received any HPV vaccine.
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
* Has known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
* Has a history of abnormal Pap test showing low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL) or atypical squamous cells - undetermined significance (ASC-US), atypical squamous cells - cannot exclude HSIL (ASC-H), atypical glandular cells, or biopsy showing CIN, AIS, or cervical cancer.
* Has a history of external genital wart, vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), AIN, vulvar cancer, vaginal cancer, or anal cancer.
* Has a history of a positive test for HPV (including HPV types not in the vaccine).
* Is currently immunocompromised or has been diagnosed as having congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease, or other autoimmune condition.
* Has a history of splenectomy.
* Has received, is receiving, or plans to receive the following immunosuppressive therapies: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide (Arava™), tumor necrosis factor alpha (TNF-α) antagonists, monoclonal antibody therapies (including rituximab \[Rituxan™\]), intravenous gamma globulin (IVIG), antilymphocyte sera, or other therapy known to interfere with the immune response. With regard to systemic corticosteroids, a participant will be excluded if the participant is currently receiving steroid therapy, has recently (defined as within 2 weeks of enrollment) received such therapy, or has received 2 or more courses of corticosteroids (orally or parenterally) lasting at least 1 week within 12 months prior to enrollment. Participants using inhaled, nasal, or topical corticosteroids are considered eligible for the study.
* Has received, is receiving, or plans to receive any immune globulin product (including RhoGAM™ \[Ortho-Clinical Diagnostics\]) or blood derived product other than IVIG.
* Has participated in an HPV vaccine clinical trial and has received either active agent or placebo.
* Has received any marketed HPV vaccine other than the 2vHPV vaccines.
Primary outcome measure(s)
- Percentage of Participants Who Are Seropositive by Competitive Luminex Immunoassay (cLIA) to HPV Types 6, 11, 31, 33, 45, 52, and 58 (Month 7) — Up to approximately 1 month post vaccination 3 (Up to approximately Month 7)
The percentage of participants who are seropositive for HPV types 6, 11, 31, 33, 45, 52, and 58 in the Prior 2vHPV Vaccine Recipients Receiving V503 group will be determined using cLIA. Seropositivity is defined as having a titer at or above the prespecified seropositivity cutoff for a given HPV type. - Percentage of Participants Who Experience at Least 1 Solicited Injection-site Adverse Event (AE) — Up to approximately Day 8 post any vaccination
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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. AEs such as redness/erythema, swelling, pain, and induration at the injection site are recorded. The percentage of participants who experience 1 or more injection-site AE will be reported. - Percentage of Participants Who Experience at Least 1 Solicited Systemic AE — Up to approximately Day 8 post any vaccination
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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Systemic AEs are those not categorized as injection-site AEs. The percentage of participants who experience 1 or more systemic AE will be reported. - Percentage of Participants Who Experience at Least 1 Serious AE (SAE) — Up to approximately Month 12
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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. An 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. The percentage of participants who experience 1 or more SAEs will be reported.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Yuhuan Center for Disease Control and Prevention ( Site 0001) | Taizhou | Zhejiang | Recruiting |
More Merck Sharp & Dohme LLC trials in China
A Study of Raludotatug Deruxtecan (R-DXd) in People With Gastrointestinal Cancers (MK-5909-005)
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Efficacy, Immunogenicity, and Safety of V503 in Chinese Males (V503-052)
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Other trials for the same condition
Efficacy, Immunogenicity, and Safety of V503 in Chinese Males (V503-052)
Active, not recruiting
Efficacy, Immunogenicity and Safety of V503 in Chinese Women Aged 20-45 Years (V503-023)
Active, not recruiting
V503 in Chinese Girls 9-14 Years Old Versus Chinese Women 20-26 Years Old (V503-071)
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07785843 on ClinicalTrials.gov ↗ ← All trials in China