이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Study of Two Doses of GSK Biologicals' Live Attenuated HRV Vaccine (Two Different Formulations) in Healthy Infants.

2016년 9월 15일 업데이트: GlaxoSmithKline

Phase II, Double-blind, Randomized, Placebo-controlled Study of 2 Doses of GSK Biologicals' Live Attenuated Human Rotavirus Vaccine at Different Virus Concentrations (10 5.2 and 10 6.4 Ffu) in Healthy Infants Following a 0, 2 Month Schedule and Previously Uninfected With Human Rotavirus.

This is a dose exploration study to assess the safety and immunogenicity of two doses of the candidate HRV vaccine at different virus concentrations in the target age group (infants approximately 2 months of age and previously uninfected with human rotavirus) and receiving concomitant administration of routine vaccinations. The study also aims at exploring the effect of unrestricted feeding on the immunogenicity of the vaccine.

연구 개요

상세 설명

All subjects enrolled from Eastern United States and Eastern Canada will continue their participation in the pilot efficacy follow-up (pilot efficacy subset).

The third dose of IPV vaccine (IPOL) may be given at visit 3, 4 or another time, at the investigator's discretion.

Comvax may be given in place of OmniHIB/ActHIB at Visit 1 and Visit 2 and the third dose of Comvax administered according to the prescribing information.

연구 유형

중재적

등록 (실제)

529

단계

  • 2 단계

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:

  • A male or female child between, and including 6 and 12 weeks (42-90 days) of age at the time of the first vaccination.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
  • Written informed consent obtained from the parents or guardians of the subject.
  • Born after a normal gestation period (between 36 and 42 weeks).

Exclusion Criteria:

  • Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the study vaccine or placebo or planned use during the study period.
  • Planned administration of a vaccine (including routine pediatric vaccines) not foreseen by the study protocol during the period starting from 14 days before each dose of vaccine(s) and ending 14 days after. Hepatitis B vaccine given concomitantly or within 14 days before and after vaccination is not an exclusion criteria.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
  • History of diphtheria, tetanus, pertussis, polio, Hib disease and/or invasive pneumococcal infection. History of invasive pneumococcal infection is not an exclusion criteria for Canadian subjects.
  • Previous vaccination against diphtheria, tetanus, pertussis, polio, Haemophilus influenzae type b, and/or Streptococcus pneumoniae. Previous vaccination against Streptococcus pneumoniae is not an exclusion criteria for Canadian subjects.
  • Use of antibiotics within 7 days preceding dose 1.
  • Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the GI tract or other serious medical condition as determined by the investigator.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
  • History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
  • Acute disease at time of enrollment.
  • Gastroenteritis within 7 days preceding the study vaccine administration.
  • Household contact with an immunosuppressed individual or pregnant women.
  • Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
  • Previous confirmed occurrence of rotavirus gastroenteritis.
  • Inability to contact parents/guardians of the subject by telephone.

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
위약 비교기: 그룹 C
Three-dose intramuscular injection (US subjects only)
Two-dose intramuscular injection (US subjects only)
Three-dose intramuscular injection (US subjects only)
Three-dose intramuscular injection (US subjects only)
다른 이름들:
  • ActHIB
Three-dose intramuscular injection (Canada only)
실험적: Group A
Human Rotavirus Vaccine - Formulation 1
Two oral doses
Three-dose intramuscular injection (US subjects only)
Two-dose intramuscular injection (US subjects only)
Three-dose intramuscular injection (US subjects only)
Three-dose intramuscular injection (US subjects only)
다른 이름들:
  • ActHIB
Three-dose intramuscular injection (Canada only)
실험적: Group B
Human Rotavirus Vaccine - Formulation 2
Two oral doses
Three-dose intramuscular injection (US subjects only)
Two-dose intramuscular injection (US subjects only)
Three-dose intramuscular injection (US subjects only)
Three-dose intramuscular injection (US subjects only)
다른 이름들:
  • ActHIB
Three-dose intramuscular injection (Canada only)

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Proportion of subjects with vaccine take
기간: Two months after the second dose
Two months after the second dose
Occurrence of any grade 2 or 3 fever, vomiting or diarrhea
기간: Within the 15-day solicited follow-up period after any dose of study vaccine.
Within the 15-day solicited follow-up period after any dose of study vaccine.

2차 결과 측정

결과 측정
기간
Occurrence of each type of solicited symptoms
기간: Within the 15-day solicited follow-up period after any dose of study vaccine
Within the 15-day solicited follow-up period after any dose of study vaccine
Occurrence of unsolicited symptoms according to WHO classification.
기간: Within 42 days after dose 1 and dose 2
Within 42 days after dose 1 and dose 2
Occurrence of serious adverse events
기간: Throughout the entire study period
Throughout the entire study period
Serum rotavirus immunoglobulin A (IgA) antibody titers
기간: At visits 1, 3 and 4 and at all Visits for pilot efficacy subset
At visits 1, 3 and 4 and at all Visits for pilot efficacy subset
Rotavirus seropositivity status
기간: Before dose 1 and at the end of the study
Before dose 1 and at the end of the study
Vaccine take (for pilot efficacy subset only)
기간: 2 months after dose 1
2 months after dose 1
Anti- polyribosyl-ribitol phosphate (PRP), anti-diphtheria and anti-tetanus toxoids, anti- pertussis toxoid (PT), anti- filamentous haemagglutinin (FHA), anti- pertactin (PRN), anti-polio type 1, 2 and 3 antibody concentrations
기간: Two months after dose 2 and at the end of the study.
Two months after dose 2 and at the end of the study.
Antibody concentrations to pneumococcal serotypes 4, 6B, 9V, 14, 18C, 19F and 23F
기간: Two months after dose 2 and at the end of the study (only in a subset of U.S. subjects)
Two months after dose 2 and at the end of the study (only in a subset of U.S. subjects)
Anti-PRP, anti-diphtheria, anti-tetanus, anti-polio type 1, 2 and 3 seroprotection status.
기간: Two months after dose 2 and at the end of the study.
Two months after dose 2 and at the end of the study.
Anti-PT, anti-FHA, anti-PRN, pneumococcal serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (only in US subjects) seropositivity status.
기간: Two months after dose 2 and at the end of the study.
Two months after dose 2 and at the end of the study.
Seropositivity status and Geometric mean titres (GMTs) of rotavirus IgA for breast fed infants compared with formula fed infants
기간: Two months after dose 2.
Two months after dose 2.
Occurrence of rotavirus gastroenteritis (in a pilot efficacy subset of subjects)
기간: Two weeks after dose 2 until the end of the rotavirus season following vaccination.
Two weeks after dose 2 until the end of the rotavirus season following vaccination.

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.

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

2000년 11월 1일

기본 완료 (실제)

2002년 9월 1일

연구 완료 (실제)

2002년 9월 1일

연구 등록 날짜

최초 제출

2008년 8월 4일

QC 기준을 충족하는 최초 제출

2008년 8월 5일

처음 게시됨 (추정)

2008년 8월 6일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2016년 9월 16일

QC 기준을 충족하는 마지막 업데이트 제출

2016년 9월 15일

마지막으로 확인됨

2016년 9월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

연구 데이터/문서

  1. 데이터 세트 사양
    정보 식별자: 444563/005
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  2. 연구 프로토콜
    정보 식별자: 444563/005
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  3. 개별 참가자 데이터 세트
    정보 식별자: 444563/005
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  4. 임상 연구 보고서
    정보 식별자: 444563/005
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  5. 정보에 입각한 동의서
    정보 식별자: 444563/005
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  6. 통계 분석 계획
    정보 식별자: 444563/005
    정보 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. .

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