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A Clinical Study of V503 in Chinese Females Who Have Previously Received a Bivalent Human Papillomavirus (HPV) Vaccine (V503-108)

3 de septiembre de 2026 actualizado por: Merck Sharp & Dohme LLC

A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Immunogenicity and Safety of V503 in Chinese Females Aged 10 to 45 Years Who Have Previously Received a Bivalent Human Papillomavirus (HPV) Vaccine

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

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

930

Fase

  • Fase 3

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto

Acepta Voluntarios Saludables

Sí

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Prior 2vHPV Vaccine Recipients Receiving V503
Participants will receive V503 at Day 1, Month 2, and Month 6
Biológico: 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
Otros nombres:
  • GARDASIL®9
  • 9-valent HPV Vaccine
Comparador de placebos: Prior 2vHPV Vaccine Recipients Receiving Placebo
Participants will receive Placebo at Day 1, Month 2, and Month 6
Biológico: Placebo
Saline administered as a 0.5-mL IM injection on Day 1, Month 2, and Month 6
Experimental: HPV Vaccine-Naïve Participants Receiving V503
Participants will receive V503 at Day 1, Month 2, and Month 6
Biológico: 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
Otros nombres:
  • GARDASIL®9
  • 9-valent HPV Vaccine
Comparador de placebos: HPV Vaccine-Naïve Participants Receiving Placebo
Participants will receive Placebo at Day 1, Month 2, and Month 6
Biológico: Placebo
Saline administered as a 0.5-mL IM injection on Day 1, Month 2, and Month 6

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Participants Who Are Seropositive by Competitive Luminex Immunoassay (cLIA) to HPV Types 6, 11, 31, 33, 45, 52, and 58 (Month 7)
Periodo de tiempo: 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.
Up to approximately 1 month post vaccination 3 (Up to approximately Month 7)
Percentage of Participants Who Experience at Least 1 Solicited Injection-site Adverse Event (AE)
Periodo de tiempo: 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.
Up to approximately Day 8 post any vaccination
Percentage of Participants Who Experience at Least 1 Solicited Systemic AE
Periodo de tiempo: 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.
Up to approximately Day 8 post any vaccination
Percentage of Participants Who Experience at Least 1 Serious AE (SAE)
Periodo de tiempo: 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.
Up to approximately Month 12

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Participants Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Periodo de tiempo: Up to approximately 1 month post vaccination (Up to approximately 7 months)
The percentage of participants who are seropositive for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 will be determined using cLIA. Seropositivity is defined as having a titer at or above the prespecified seropositivity cutoff for a given HPV type.
Up to approximately 1 month post vaccination (Up to approximately 7 months)
cLIA Geometric Mean Titers (GMTs) for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Periodo de tiempo: Up to approximately 1 month post vaccination (Up to approximately 7 months)
Antibodies to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 will be measured using a cLIA. Antibody titers will be expressed as milli Merck Units/milliliter (mMU/mL).
Up to approximately 1 month post vaccination (Up to approximately 7 months)
Difference in Percentage of Participants Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 Between Prior 2vHPV Vaccine Recipients and HPV Vaccine-Naïve Participants
Periodo de tiempo: Up to approximately 1 month post vaccination (Up to approximately 7 months)
The percentage of participants who are seropositive for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 will be determined using cLIA. Seropositivity is defined as having a titer at or above the prespecified seropositivity cutoff for a given HPV type. The difference in seropositivity percentages between participants who previously received a 2vHPV vaccine and subsequently receive V503 and participants who were HPV vaccine-naïve and receive V503 will be evaluated.
Up to approximately 1 month post vaccination (Up to approximately 7 months)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Merck Sharp & Dohme LLC

Investigadores

  • Director de estudio: Medical Director, Merck Sharp & Dohme LLC

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

9 de octubre de 2026

Finalización primaria (Estimado)

18 de diciembre de 2027

Finalización del estudio (Estimado)

22 de diciembre de 2028

Fechas de registro del estudio

Enviado por primera vez

21 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

21 de agosto de 2026

Publicado por primera vez (Actual)

25 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

3 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • V503-108

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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