ZOSTAVAX™ Safety Study in Subjects ≥ 60 Years of Age (V211-020)
A Phase IV Clinical Trial to Evaluate the Safety and Tolerability of ZOSTAVAX™ in Subjects ≥ 60 Years of Age
연구 개요
연구 유형
등록 (실제)
단계
- 4단계
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 60+ years of Age
- Signed an informed consent prior to the start of study
- Non-Feverish, (less than 101.0°F / 38.3°C) on day of vaccination
- Females must be postmenopausal or have a negative pregnancy test
Exclusion Criteria:
- A history of allergic reaction to any vaccine component (including gelatin or neomycin)
- Prior receipt of any varicella or zoster vaccine
- Any live virus vaccine administered within 4 weeks before the start of the study or scheduled during the 42 days after vaccination
- Any inactivated virus vaccine, except for flu vaccine, administered within 7 days before the start of the study or scheduled during the 42 days after vaccination
- Subject is pregnant or breastfeeding
- Participation in an investigational drug or vaccine study within the last 30 days prior to the start of the study or expected during the 42 days after vaccination
- An ongoing illness (including active untreated tuberculosis) that might interfere with or prevent the subject from completion of the study
- Use of immunosuppressive therapy. Subjects taking corticosteroids such as prednisone should be excluded. Excluded immunosuppressive therapies also include chemotherapeutic agents used to treat cancer or other conditions, and treatments associated with organ or bone marrow transplantation
- Known or suspected immune dysfunction that is caused by a medical condition or any other cause. Examples of medical conditions associated with immune dysfunction include congenital immunodeficiency, human immunodeficiency virus (HIV) infection, organ or bone marrow transplantation, leukemia, lymphoma, Hodgkin's disease, multiple myeloma, or generalized malignancy. Subjects with a history of cancer who are not on active treatment and are not thought to have a weakened immune system at the time of enrollment will be eligible
- Any active use of non-topical antiviral therapy including but not limited to acyclovir, famciclovir, valacyclovir, ganciclovir, foscarnet, brivudine, and cidofovir
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 1
Arm 1: vaccine
|
single 0.65 mL Zoster Vaccine, Live injection.
6 month treatment period.
|
|
위약 비교기: 2
Arm 2: Placebo Comparator
|
single 0.65 mL Placebo injection.
6 month treatment period.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Serious Adverse Events Reported Within 42 Days Postvaccination
기간: 42 Days
|
Only Serious Adverse Events were collected and analyzed for this study. A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgement. |
42 Days
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Serious Adverse Events Reported Within 6 Months (Day 1 to 182) Postvaccination
기간: 6 months
|
Only Serious Adverse Events were collected and analyzed for this study. A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgement. |
6 months
|
공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- V211-020
- 2007_606
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
http://engagezone.msd.com/ds_documentation.php
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. .
Zoster Vaccine, Live에 대한 임상 시험
-
University Medical Center GroningenGGZ Drenthe Mental Health Institution모병
-
GlaxoSmithKline완전한대상포진미국, 호주, 독일, 스페인, 일본, 대만, 스웨덴, 대한민국, 홍콩, 멕시코, 캐나다, 프랑스, 이탈리아, 브라질, 에스토니아, 영국, 체코, 핀란드