A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Children With Sickle Cell Disease (V114-023/PNEU-SICKLE)
2021년 5월 21일 업데이트: Merck Sharp & Dohme LLC
A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Children With Sickle Cell Disease (PNEU-SICKLE)
This study is designed to describe the safety, tolerability, and immunogenicity of V114 in children with sickle cell disease.
연구 개요
연구 유형
중재적
등록 (실제)
104
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Athens, 그리스, 115 27
- Agia Sophia Children s Hospital ( Site 0700)
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Thessaloniki, 그리스, 546 42
- Hippokration General Hospital of Thessaloniki ( Site 0701)
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Santo Domingo, 도미니카 공화국, 10122
- Clinical Research Republica Dominicana ( Site 0401)
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Santo Domingo, 도미니카 공화국, 10205
- Caimed Dominicana S.A.S ( Site 0400)
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Santo Domingo
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Distrito Nacional, Santo Domingo, 도미니카 공화국, 10204
- Fundacion Dominicana de Perinatologia PRO BEBE INC ( Site 0402)
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Delaware
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Wilmington, Delaware, 미국, 19803
- Nemours/Alfred I. duPont Hospital for Children ( Site 0113)
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Georgia
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Atlanta, Georgia, 미국, 30303
- Children's Healthcare of Atlanta ( Site 0100)
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Michigan
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Detroit, Michigan, 미국, 48201
- Children's Hospital of Michigan ( Site 0111)
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New Jersey
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Newark, New Jersey, 미국, 07112
- Newark Beth Israel Medical Center ( Site 0115)
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New York
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Rochester, New York, 미국, 14642
- University of Rochester Medical Center ( Site 0105)
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Ohio
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Cincinnati, Ohio, 미국, 45229
- Cincinnati Children's Hospital Medical Center ( Site 0101)
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Salvador, 브라질, 40420-000
- Hospital Santo Antonio - Obras Sociais Irma Dulce ( Site 0205)
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Sao Paulo, 브라질, 01221-900
- Santa Casa de Misericordia de Sao Paulo ( Site 0202)
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MG
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Belo Horizonte, MG, 브라질, 30150-221
- Santa Casa de Misericordia de Belo Horizonte ( Site 0200)
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Genova, 이탈리아, 16132
- Ospedale San Martino ( Site 0800)
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Atlantico
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Barranquilla, Atlantico, 콜롬비아, 080020
- Clinica de la Costa Ltda. ( Site 0300)
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Valle Del Cauca
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Cali, Valle Del Cauca, 콜롬비아, 760045
- Centro de Estudios en Infectologia Pediatrica SAS ( Site 0301)
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Panama, 파나마, 0816-00383
- Cevaxin ( Site 0500)
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Panama, 파나마, 0816-00383
- Cevaxin ( Site 0502)
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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
5년 (어린이)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Documented diagnosis of sickle cell disease in their medical record
Female participants: not pregnant or breastfeeding, and at least 1 of the following conditions apply:
1) not a woman of childbearing potential (WOCBP) as defined in the protocol, or 2) a WOCBP who agrees to follow the contraceptive guidance in the protocol during the treatment period and for at least 6 weeks after the last dose of study vaccine
- Has a legally acceptable representative who understands the study procedures, alternate treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent/assent.
Exclusion Criteria:
- History of Invasive Pneumococcal Disease (positive blood culture, positive cerebrospinal fluid culture, or positive culture at another sterile site) or known history of other culture-positive pneumococcal disease within 3 years of Visit 1 (Day 1)
- Known hypersensitivity to any component of pneumococcal conjugate vaccine (PCV), or any diphtheria toxoid-containing vaccine
- Known or suspected impairment of immunological function
- History of congenital or acquired immunodeficiency
- Documented human immunodeficiency virus (HIV) infection
- History of autoimmune disease (including but not limited to systemic lupus erythematosus, antiphospholipid syndrome, Behcet's disease, autoimmune thyroid disease, polymyositis and dermatomyositis, scleroderma, or type 1 diabetes mellitus)
- Known coagulation disorder contraindicating intramuscular vaccination
- History of malignancy ≤5 years prior to signing informed consent/assent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
- A WOCBP who has a positive urine or serum pregnancy test before the first vaccination at Visit 1 (Day 1)
- Received any PCV or pneumococcal polysaccharide vaccine <3 years before Visit 1 (Day 1)
- Five (5) years of age and has received <3 doses of PCV
- Receiving immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease. Note: hydroxyurea is permitted
- Received immunoglobulin within 6 months before receipt of study vaccine
- Participated in another clinical study of an investigational product within 2 months before the beginning or anytime during the duration of the current clinical study. Participants enrolled in observational studies may be included
- Recent history (within the last year) of more than 3 inpatient hospitalizations
- At the time of signing informed consent/assent, is a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence as assessed by the study investigator
- History or current evidence of any condition, therapy, lab abnormality or other circumstance that might expose the participant to risk by participating in the study, confound the results of the study, or interfere with the participant's participation for the full duration of the study in the opinion of the Investigator
- Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.
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: V114
Participants will receive a single 0.5 mL intramuscular (IM) injection of V114 on Day 1.
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V114 pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose
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활성 비교기: Prevnar 13™
Participants will receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1.
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Prevnar 13™ pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml dose
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Percentage of Participants With a Solicited Injection-site Adverse Event
기간: Up to 14 days post-vaccination
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An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Solicited injection-site AEs included injection-site erythema (redness), injection-site induration (hard lump), injection-site pain (tenderness), and injection-site swelling.
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Up to 14 days post-vaccination
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Percentage of Participants With a Solicited Systemic Adverse Event
기간: Up to 14 days post-vaccination
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An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Solicited systemic AEs included arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain), and urticaria (hives or welts).
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Up to 14 days post-vaccination
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Percentage of Participants With a Vaccine-related Serious Adverse Event
기간: Up to 6 months post-vaccination
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A serious adverse event (SAE) is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment.
SAEs that were reported by the investigator to be at least possibly related to the study vaccination were summarized.
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Up to 6 months post-vaccination
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Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30
기간: Day 30
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The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay.
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Day 30
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30
기간: Day 30
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Sera from participants was used to measure GMT of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 using the multiplexed opsonophagocytic assay (MOPA).
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Day 30
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Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30
기간: Day 1 (Baseline) and Day 30
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IgG for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes unique to V114 (22F and 33F) was determined using an electrochemiluminescence assay.
GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline (Day 1, pre-vaccination).
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Day 1 (Baseline) and Day 30
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GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30
기간: Day 1 (Baseline) and Day 30
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Activity for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes unique to V114 (22F and 33F) was determined using a MOPA.
GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline (Day 1, pre-vaccination).
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Day 1 (Baseline) and Day 30
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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)
2019년 1월 23일
기본 완료 (실제)
2020년 6월 8일
연구 완료 (실제)
2020년 6월 8일
연구 등록 날짜
최초 제출
2018년 11월 2일
QC 기준을 충족하는 최초 제출
2018년 11월 2일
처음 게시됨 (실제)
2018년 11월 6일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 6월 16일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 5월 21일
마지막으로 확인됨
2021년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- V114-023 (기타 식별자: Merck Protocol Number)
- 2018-001152-35 (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
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
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. .