A Clinical Study of V503 in Chinese Females Who Have Previously Received a Bivalent Human Papillomavirus (HPV) Vaccine (V503-108)
2026년 9월 3일 업데이트: 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
연구 개요
연구 유형
중재적
등록 (추정된)
930
단계
- 3단계
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
예
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Prior 2vHPV Vaccine Recipients Receiving V503
Participants will receive V503 at Day 1, Month 2, and Month 6
|
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
다른 이름들:
|
|
위약 비교기: Prior 2vHPV Vaccine Recipients Receiving Placebo
Participants will receive Placebo at Day 1, Month 2, and Month 6
|
Saline administered as a 0.5-mL IM injection on Day 1, Month 2, and Month 6
|
|
실험적: HPV Vaccine-Naïve Participants Receiving V503
Participants will receive V503 at Day 1, Month 2, and Month 6
|
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
다른 이름들:
|
|
위약 비교기: HPV Vaccine-Naïve Participants Receiving Placebo
Participants will receive Placebo at Day 1, Month 2, and Month 6
|
Saline administered as a 0.5-mL IM injection on Day 1, Month 2, and Month 6
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of Participants Who Are Seropositive by Competitive Luminex Immunoassay (cLIA) to HPV Types 6, 11, 31, 33, 45, 52, and 58 (Month 7)
기간: 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)
기간: 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
기간: 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)
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of Participants Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
기간: 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
기간: 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
기간: 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)
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: Medical Director, Merck Sharp & Dohme LLC
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 10월 9일
기본 완료 (추정된)
2027년 12월 18일
연구 완료 (추정된)
2028년 12월 22일
연구 등록 날짜
최초 제출
2026년 8월 21일
QC 기준을 충족하는 최초 제출
2026년 8월 21일
처음 게시됨 (실제)
2026년 8월 25일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 3일
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- V503-108
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .