- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01198769
Immunogenicity and Safety Study of Rotarix TM in Taiwanese Infants Who Received Hepatitis B Immunoglobulin After Birth.
Immunogenicity, Reactogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Taiwanese Infants Who Received Hepatitis B Immunoglobulin After Birth.
연구 개요
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Taipei, 대만, 100
- GSK Investigational Site
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
- A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
- Written informed consent obtained from the parent(s)/Legally Acceptable Representative(s) of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Infants who have received a previous dose of hepatitis B immunoglobulin after birth.
Exclusion Criteria:
- Child in care.
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs with the exception of Hepatitis B immunoglobulin since birth. Child is unlikely to remain in the study area for the duration of the study.
- Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- Previous vaccination against rotavirus.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Family history of congenital or hereditary immunodeficiency.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
- Major congenital defects or serious chronic illness.
- Acute disease and/or fever at the time of enrolment.
- Administration of immunoglobulins (with the exception of HBIG) and/or any blood products since birth or planned administration during the study period.
- Gastroenteritis within 7 days preceding the study vaccine administration.
- Previous confirmed occurrence of Rotavirus gastroenteritis.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Rotarix Group
subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
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Oral, 2 doses
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Number of Seroconverted Subjects for Serum Anti-rotavirus Immunoglobulin A (IgA) Antibody.
기간: 2 months post-Dose 2 (at study Month 4)
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Seroconversion is defined as the appearance of IgA antibody concentration equal to or above (≥) 20 Units per millilitre (U/mL) in the serum of subjects who were seronegative before vaccination.
A seronegative subject is a subject with anti-rotavirus IgA antibody concentration below (<) 20 U/mL.
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2 months post-Dose 2 (at study Month 4)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Serum Anti-rotavirus IgA Antibody Concentrations.
기간: 2 months post-Dose 2 (at study Month 4)
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Concentrations were expressed as geometric mean antibody concentration in units per millilitre (U/mL), calculated on all subjects.
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2 months post-Dose 2 (at study Month 4)
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Number of Subjects Reporting Solicited General Symptoms.
기간: During the 8-day (Days 0-7) post-vaccination period
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Solicited general symptoms assessed were cough, diarrhoea, irritability, loss of appetite, temperature (any temperature was defined as a tympanic on rectal setting temperature ≥ 38.0 degrees Celsius) and vomiting.
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During the 8-day (Days 0-7) post-vaccination period
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Number of Subjects With Rotavirus (RV) Present in the Gastroenteritis (GE) Stool Sample.
기간: From Day 0 (first vaccine dose) to study Month 4 (2 months post-Dose 2)
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RV was not identified in the one GE stool sample collected in the study. Two subjects reported GE episode between vaccination Dose 1 and before vaccination Dose 2. For one of them, GE stool sample was not collected and for the other subject no RV was identified in the GE stool sample. GE symptoms were defined as diarrhoea with or without vomiting. A GE stool sample was collected as soon as possible after the illness began by the parent/guardian of the subject. Presence of RV antigen was detected by Enzyme-linked immunosorbent assay (ELISA). |
From Day 0 (first vaccine dose) to study Month 4 (2 months post-Dose 2)
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Number of Subjects Reporting Unsolicited Adverse Events (AEs).
기간: Within the 31-day (Days 0-30) follow-up period after vaccination
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An unsolicited adverse event is any adverse event (i.e.
any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
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Within the 31-day (Days 0-30) follow-up period after vaccination
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Number of Subjects Reporting Serious Adverse Events (SAEs).
기간: During the entire study period (from Dose 1 at Day 0 up to Month 4)
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SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
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During the entire study period (from Dose 1 at Day 0 up to Month 4)
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공동 작업자 및 조사자
스폰서
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
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 114351
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
연구 데이터/문서
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주석이 달린 사례 보고서 양식
정보 식별자: 114351정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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연구 프로토콜
정보 식별자: 114351정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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정보에 입각한 동의서
정보 식별자: 114351정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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개별 참가자 데이터 세트
정보 식별자: 114351정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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데이터 세트 사양
정보 식별자: 114351정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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통계 분석 계획
정보 식별자: 114351정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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임상 연구 보고서
정보 식별자: 114351정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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. .
Rotarix TM에 대한 임상 시험
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