Efficacy and Tolerability Study of V501 in Japanese Males (V501-122)
2019년 3월 25일 업데이트: Merck Sharp & Dohme LLC
A Phase III Placebo-controlled Clinical Trial to Study the Tolerability, Immunogenicity and Efficacy of V501 in 16- to 26-year-old Japanese Men
A study to evaluate the efficacy and tolerability of V501 (quadrivalent Human Papilloma Virus [HPV] [Type 6, 11, 16 and 18] L1 Virus-Like Particle vaccine, GARDASIL™) in healthy, 16- to 26-year old Japanese males.
The hypotheses tested are: 1) V501 reduces the combined incidence of HPV 6-, 11-, 16-, or 18-related persistent infection compared with placebo, and 2) V501 reduces the combined incidence of HPV 6-, 11-, 16-, or 18-related persistent infection, condyloma acuminata, penile/perianal/perineal intraepithelial neoplasia, or penile, perianal, or perineal cancer compared with placebo.
연구 개요
연구 유형
중재적
등록 (실제)
1124
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
16년 (어린이, 성인)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
남성
설명
Inclusion Criteria:
- Japanese
- No clinical evidence of gross genital lesion suggesting sexually-transmitted disease and no clinically present external genital warts
- Other inclusion criteria will be discussed with the investigator during screening
Exclusion Criteria:
- History of known prior vaccination with an HPV vaccine or plans to receive one outside the study
- History of external genital warts
- History of severe allergic reaction that required medical intervention
- Received immune globulin or blood-derived products in the past 6 months or plan to receive any before Month 7 of the study
- 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
- Received immunosuppressive therapy in the past year, excluding inhaled, nasal, or topical corticosteroids and certain regimens of systemic corticosteroids
- Known thrombocytopenia or coagulation disorder that would contraindicate intramuscular injections
- Ongoing alcohol or drug abuse within the past 12 months
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: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: V501
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Follow-up was up to Month 36.
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Formulated with aluminum hydroxyphosphate sulfate (AAHS) adjuvant
다른 이름들:
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위약 비교기: Placebo
Participants received placebo 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Follow-up was up to Month 36.
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Formulated with AAHS adjuvant
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Combined Incidence of HPV Type 6, 11, 16, or 18-related Persistent Infection
기간: Up to Month 36
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Persistent infection was defined as 1) polymerase chain reaction (PCR) positive to HPV Type 6, 11, 16, or 18 in 2 consecutive anogenital or biopsy samples collected ≥4 months apart, or 2) Pathology Panel consensus diagnosis of condyloma acuminate, penile/perianal/perineal intraepithelial neoplasia (PIN), penile, perianal, or perineal cancer and PCR detection of HPV Type 6, 11, 16, or 18 in an adjacent section and PCR positive for the same HPV type at a separate adjacent visit.
The combined incidence of HPV Type 6, 11, 16, or 18 persistent infection detected in samples from ≥2 consecutive visits ≥6 months apart was assessed.
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Up to Month 36
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Percentage of Participants With Maximum Temperature ≥37.5°C Reported on the Vaccination Report Card
기간: Up to 5 days after any vaccination
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Body temperature (oral or oral equivalent) was recorded on the Vaccination Report Card (VRC).
The percentage of participants with a maximum temperature ≥37.5°C was summarized.
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Up to 5 days after any vaccination
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Percentage of Participants With an Injection-site Adverse Event Prompted on the Vaccination Report Card
기간: Up to 5 days after any vaccination
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An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study drug.
An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure.
Any worsening of a preexisting condition that is temporally associated with the study drug or protocol-specified procedure is also an AE.
The percentage of participants with an injection-site AE prompted on the VRC (erythema, pain, and swelling) was summarized.
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Up to 5 days after any vaccination
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Percentage of Participants With a Systemic Adverse Event
기간: Up to 15 days after any vaccination
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An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study drug.
An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure.
Any worsening of a preexisting condition that is temporally associated with the study drug or protocol-specified procedure is also an AE.
The percentage of participants with a systemic AE was summarized.
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Up to 15 days after any vaccination
|
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Percentage of Participants With a Vaccine-related Systemic Adverse Event
기간: Up to 15 days after any vaccination
|
An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study drug.
An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure.
Any worsening of a preexisting condition that is temporally associated with the study drug or protocol-specified procedure is also an AE.
Vaccine-related AEs are those that were deemed possibly, probably, or definitely related to vaccine administration by the investigator.
The percentage of participants with a vaccine-related systemic AE was summarized.
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Up to 15 days after any vaccination
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Combined Incidence of HPV Type 6, 11, 16, or 18-related Persistent Infection or Disease
기간: Up to Month 36
|
Persistent infection was defined as 1) polymerase chain reaction (PCR) positive to HPV Type 6, 11, 16, or 18 in 2 consecutive anogenital or biopsy samples collected ≥4 months apart, or 2) Pathology Panel consensus diagnosis of condyloma acuminate, penile/perianal/perineal intraepithelial neoplasia (PIN), penile, perianal, or perineal cancer and PCR detection of HPV Type 6, 11, 16, or 18 in an adjacent section and PCR positive for the same HPV type at a separate adjacent visit.
The incidence of persistent infection detected in samples from ≥2 consecutive visits ≥6 months apart was assessed.
Disease was defined as HPV Type 6, 11, 16, or 18-related condyloma acuminate, PIN, penile, perianal, or perineal cancer.
The combined incidence of HPV Type 6, 11, 16, or 18 persistent infection or disease was assessed.
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Up to Month 36
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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 (실제)
2013년 6월 27일
기본 완료 (실제)
2017년 8월 30일
연구 완료 (실제)
2017년 8월 30일
연구 등록 날짜
최초 제출
2013년 5월 22일
QC 기준을 충족하는 최초 제출
2013년 5월 22일
처음 게시됨 (추정)
2013년 5월 27일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 4월 2일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 3월 25일
마지막으로 확인됨
2019년 3월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- V501-122 (기타 식별자: Merck Protocol Number)
- 132237 (레지스트리 식별자: JAPIC-CTI)
- 2015-002931-16 (EudraCT 번호)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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