Efficacy, Safety, Reactogenicity & Immunogenicity of the Rotarix Vaccine in Japanese Infants
2019년 12월 27일 업데이트: GlaxoSmithKline
Efficacy, Safety, Reactogenicity and Immunogenicity Study of the Lyophilised Formulation of Rotarix Vaccine in Healthy Japanese Infants
This study is undertaken to provide the regulatory authorities in Japan with immunogenicity, efficacy, safety and reactogenicity data of GSK Biologicals' Human Rotavirus [HRV] vaccine, given as a 2-dose primary vaccination, in healthy Japanese infants aged approximately 2 months at the time of the first dose and previously uninfected with HRV.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
연구 개요
상세 설명
Combined diphtheria and tetanus toxoids and acellular pertussis (DTPa) and Hepatitis B (HBV) vaccines are allowed to be co-administered along with Rotarix vaccine/Placebo.
연구 유형
중재적
등록 (실제)
765
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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Aichi, 일본, 451-0052
- GSK Investigational Site
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Chiba, 일본, 275-8580
- GSK Investigational Site
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Fukuoka, 일본, 802-8533
- GSK Investigational Site
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Hiroshima, 일본, 720-8520
- GSK Investigational Site
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Hiroshima, 일본, 734-8530
- GSK Investigational Site
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Hiroshima, 일본, 737-0811
- GSK Investigational Site
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Hiroshima, 일본, 730-8518
- GSK Investigational Site
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Hiroshima, 일본, 730-8798
- GSK Investigational Site
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Hokkaido, 일본, 065-0033
- GSK Investigational Site
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Hokkaido, 일본, 003-0021
- GSK Investigational Site
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Kagawa, 일본, 765-8501
- GSK Investigational Site
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Kanagawa, 일본, 247-8533
- GSK Investigational Site
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Miyagi, 일본, 983-8520
- GSK Investigational Site
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Miyagi, 일본, 981-3203
- GSK Investigational Site
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Nagano, 일본, 386-8610
- GSK Investigational Site
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Nagasaki, 일본, 856-8562
- GSK Investigational Site
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Niigata, 일본, 957-8588
- GSK Investigational Site
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Okayama, 일본, 701-1192
- GSK Investigational Site
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Okayama, 일본, 701-0204
- GSK Investigational Site
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Osaka, 일본, 591-8025
- GSK Investigational Site
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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
1개월 (어린이)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
- Healthy male or female infant between, and including, 6 and 14 weeks (42-104 days) of age at the time of the first vaccination.
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Written informed consent obtained from the parent or guardian of the subject.
- Born between a gestation period of 36 and 42 weeks inclusive.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the HRV vaccine within 30 days preceding the first dose of HRV vaccine, or planned use during the study period.
- History of use of experimental rotavirus vaccine.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- 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 (pharmaceutical product or device).
- Uncorrected congenital malformation (such as Meckel's diverticulum) of the gastrointestinal tract that would predispose for intussusception.
- Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition determined by the investigator.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Previous confirmed occurrence of RV GE.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
- A family history of congenital or hereditary immunodeficiency.
- Acute disease at the time of enrolment.
- Gastroenteritis within 7 days preceding the study vaccine administration.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
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: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Rotarix Group
Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
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Two-dose oral vaccination.
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위약 비교기: Placebo Group
Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
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Two-dose oral administration.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains
기간: From 2 weeks after Dose 2 up to 2 years of age
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Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode.
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From 2 weeks after Dose 2 up to 2 years of age
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Number of Subjects Reporting Severe Rotavirus (RV) Gastroenteritis (GE) Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains
기간: From 2 weeks after Dose 2 up to 2 years of age
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A subject was considered as reporting severe rotavirus gastroenteritis when the subject scored 11 or more on a 20-point scoring system (Vesikari scoring system).
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From 2 weeks after Dose 2 up to 2 years of age
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Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains of G1 Type
기간: From 2 weeks after Dose 2 up to 2 years of age
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Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode. Severe RV GE was defined as an episode of rotavirus gastroenteritis with score ≥ 11 on a 20-point scoring system (Vesikari scoring system). |
From 2 weeks after Dose 2 up to 2 years of age
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Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains of Non-G1 Types
기간: From 2 weeks after Dose 2 up to 2 years of age
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Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode. Severe rotavirus gastroenteritis was defined as an episode of rotavirus gastroenteritis with score ≥ 11 on a 20-point scoring system (Vesikari scoring system). |
From 2 weeks after Dose 2 up to 2 years of age
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Number of Subjects Hospitalized Due to Rotavirus (RV) Gastroenteritis (GE) Caused by the Circulating Wild-type RV Strains
기간: From 2 weeks after Dose 2 up to 2 years of age
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Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode.
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From 2 weeks after Dose 2 up to 2 years of age
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Number of Subjects Reporting Any Rotavirus (RV) Gatroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains
기간: From Dose 1 up to 2 years of age
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Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode. Severe rotavirus gastroenteritis was defined as an episode of rotavirus gastroenteritis with score ≥ 11 on a 20-point scoring system (Vesikari scoring system). |
From Dose 1 up to 2 years of age
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Serum Anti-rotavirus Immunoglobulin A (IgA) Antibody Concentration
기간: 2 months after Dose 2
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Anti-rotavirus immunoglobulin A antibody concentrations are given as geometric mean concentrations (GMCs).
Arbitrary 'zero' values were set in the Placebo Group since the GMC was below the assay cut-off value (20 U/mL).
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2 months after Dose 2
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Number of Subjects Seroconverted for Anti-rotavirus Immunoglobulin A (IgA) Antibodies
기간: 2 months after Dose 2
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Seroconversion was defined as the appearance of anti-rotavirus immunoglobulin A antibody concentration ≥ 20 units (U)/milliliter (mL) in subjects initially (i.e.
prior to the first dose of rotarix) seronegative.
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2 months after Dose 2
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Number of Subjects Reporting Solicited Symptoms
기간: During the 8-day follow-up period after each dose
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Solicited symptoms assessed include cough, diarrhoea, fever, irritability, loss of appetite and vomiting.
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During the 8-day follow-up period after each dose
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Number of Subjects Reporting Unsolicited Adverse Events (AEs)
기간: During the 31-day follow-up period after each dose
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Unsolicited adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
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During the 31-day follow-up period after each dose
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Number of Subjects Reporting Serious Adverse Events (SAEs)
기간: Up to 2 years of age
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Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
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Up to 2 years of age
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Buyse H, Vinals C, Karkada N, Han HH. The human rotavirus vaccine Rotarix in infants: an integrated analysis of safety and reactogenicity. Hum Vaccin Immunother. 2014;10(1):19-24. doi: 10.4161/hv.26476. Epub 2013 Oct 8.
- Kawamura N, Tokoeda Y, Oshima M, Okahata H, Tsutsumi H, Van Doorn LJ, Muto H, Smolenov I, Suryakiran PV, Han HH. Efficacy, safety and immunogenicity of RIX4414 in Japanese infants during the first two years of life. Vaccine. 2011 Aug 26;29(37):6335-41. doi: 10.1016/j.vaccine.2011.05.017. Epub 2011 Jun 2.
- Kawamura N et al. Efficacy of Human Rotavirus (G1P[8] strain) Vaccine (HRV) RIX4414 in Japanese Infants during the Two-year Efficacy Follow-up Period. Abstract presented at the 114th Annual Meeting of Japan Pediatric Society (JPS). Tokyo, Japan, 12-14 August 2011.
- Kawamura N et al. Efficacy of human rotavirus vaccine RIX4414 in Japanese infants from 2 weeks post dose 2 up to data lock point. Abstract presented at the 28th meeting of European Society for Paediatric Infectious Diseases (ESPID). Nice, France, 4-8 May 2010.
- Bergman H, Henschke N, Hungerford D, Pitan F, Ndwandwe D, Cunliffe N, Soares-Weiser K. Vaccines for preventing rotavirus diarrhoea: vaccines in use. Cochrane Database Syst Rev. 2021 Nov 17;11(11):CD008521. doi: 10.1002/14651858.CD008521.pub6.
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)
2007년 6월 19일
기본 완료 (실제)
2009년 3월 31일
연구 완료 (실제)
2009년 11월 21일
연구 등록 날짜
최초 제출
2007년 5월 29일
QC 기준을 충족하는 최초 제출
2007년 5월 29일
처음 게시됨 (추정)
2007년 5월 30일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 1월 2일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 12월 27일
마지막으로 확인됨
2019년 12월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 107625
- 2015-001543-36 (EudraCT 번호)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD 공유 기간
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD 공유 액세스 기준
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place.
Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- CSR
연구 데이터/문서
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정보에 입각한 동의서
정보 식별자: 107625정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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통계 분석 계획
정보 식별자: 107625정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
-
개별 참가자 데이터 세트
정보 식별자: 107625정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
-
연구 프로토콜
정보 식별자: 107625정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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데이터 세트 사양
정보 식별자: 107625정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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주석이 달린 사례 보고서 양식
정보 식별자: 107625정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
-
임상 연구 보고서
정보 식별자: 107625정보 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. .