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

Study to Evaluate the Immunogenicity and Safety of an Investigational Pandemic Influenza Vaccine in Children

2019년 4월 24일 업데이트: GlaxoSmithKline

Safety and Immunogenicity of GSK Biologicals' (Pre-) Pandemic Influenza Candidate Vaccine (GSK1562902A) in Children Aged 6 to 35 Months

The objective of the study is to evaluate the immunogenicity and safety of prime-boost vaccination schedule of GSK Biologicals' investigational vaccine GSK1562902A.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

This protocol posting was modified according to the protocol amendment 2 (dated 16-June-2011). The impacted section is eligibility criteria.

연구 유형

중재적

등록 (실제)

113

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 싱가포르
      • Singapore, 싱가포르, 119074
        • GSK Investigational Site
      • Singapore, 싱가포르, 228510
        • GSK Investigational Site
  • 호주
    • Australian Capital Territory
      • Garran, Australian Capital Territory, 호주, 2606
        • GSK Investigational Site
    • New South Wales
      • Westmead, New South Wales, 호주, 2145
        • GSK Investigational Site
    • South Australia
      • North Adelaide, South Australia, 호주, 5006
        • GSK Investigational Site
    • Victoria
      • Carlton, Victoria, 호주, 3053
        • GSK Investigational Site

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

6개월 (어린이)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Subjects who the investigator believes that parents/Legally Acceptable Representatives (LARs) can and will comply with the requirements of the protocol.
  • Children, male or female between, and including, 6 and 35 months of age at the time of first study vaccination.
  • Written informed consent obtained from the parent(s)/LAR(s) of the subject.
  • Healthy children as established by medical history and clinical examination before entering the study.
  • Parent/LAR access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.
  • Subjects who are likely to reside in the vicinity of the study centre for the duration of the study. In studies using the home-based model for vaccination and follow-up, subjects who are likely to remain in the vicinity of the area where they were recruited.

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccine(s) 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 within six months prior to the first vaccine dose.
  • Planned administration of any vaccine 30 days prior and 21 days after any study vaccine administration.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines such as egg protein or thiomersal.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • History of any neurological disorders or seizures.
  • Acute disease at the time of enrolment.
  • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests.
  • Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned administration during the study period.
  • Any condition which, in the opinion of the investigator, renders the subject unfit for participation in the study.
  • Child in care.
  • Previous vaccination at any time with an H5N1 vaccine.
  • Medical history of physician-confirmed infection with a H5N1 virus.

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: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: GSK1562902A 6 to 12 M Group
Subjects between 6 and 12 months of age (6 to 12 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
생물학적: GSK Biologicals' investigational vaccine GSK1562902A
Three intramuscular injections
실험적: GSK1562902A 12 to 24 M Group
Subjects between 12 and 24 months of age (12 to 24 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
생물학적: GSK Biologicals' investigational vaccine GSK1562902A
Three intramuscular injections
실험적: GSK1562902A 24 to 36 M Group
Subjects between 24 and 36 months of age (24 to 36 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
생물학적: GSK Biologicals' investigational vaccine GSK1562902A
Three intramuscular injections

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of Seroconverted Subjects in Terms of H5N1 Hemagglutination Inhibition (HI) Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
기간: At Day 192
A seroconverted subject is defined as a subject that had either a pre-vaccination (Day 0) titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer on Day 192.
At Day 192
Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain
기간: At Day 192
Mean Geometric Change is defined as the geometric mean of the within-subject ratios of the post vaccination (Day 192) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer (i.e. post-vaccination divided by pre-vaccination titer).
At Day 192
Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain
기간: At Day 192
A seroprotected subject is defined as a subject with a serum H5N1 HI antibody titer ≥1:40.
At Day 192

2차 결과 측정

결과 측정
측정값 설명
기간
Hemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/05/2005 H5N1 Virus Strain
기간: At Day 0, Day 42, Day 182, Day 192 and Day 364
Titers were presented as geometric mean titers (GMTs). Analyses were done by age stratum and overall.
At Day 0, Day 42, Day 182, Day 192 and Day 364
Hemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/01/2005 H5N1 Virus Strain
기간: At Day 0, Day 182, Day 192 and Day 364
Titers were presented as geometric mean titers (GMTs). Analyses were done by age stratum and overall.
At Day 0, Day 182, Day 192 and Day 364
Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005
기간: At Day 0, Day 42, Day 182, Day 192 and Day 364
A seropositive subject is defined as a subject with a serum H5N1 HI antibody titer ≥ 1:10.
At Day 0, Day 42, Day 182, Day 192 and Day 364
Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
기간: At Day 0, Day 182, Day 192 and Day 364
A seropositive subject is defined as a subject with a serum H5N1 HI antibody titer ≥ 1:10.
At Day 0, Day 182, Day 192 and Day 364
Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
기간: At Day 42, Day 182, Day 192 and Day 364
A seroconverted subjects is defined as a subject who had either a pre vaccination (Day 0) titer <1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a 4-fold increase in post-vaccination titer.
At Day 42, Day 182, Day 192 and Day 364
Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
기간: At Day 182 and Day 364
A seroconverted subjects is defined as a subject who had either a pre vaccination (Day 0) titer <1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a 4-fold increase in post-vaccination titer. Data for Day 192 are presented under Primary Outcome Measures.
At Day 182 and Day 364
Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 Virus Strain
기간: At Day 0, Day 42, Day 182, Day 192 and Day 364
A seroprotected subject is defined as a subject with a serum H5N1 HI antibody titer ≥1:40.
At Day 0, Day 42, Day 182, Day 192 and Day 364
Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
기간: Day 0, Day 182 and Day 364
A seroprotected subject is defined as a subject with a serum H5N1 HI antibody titer ≥1:40. Data for Day 192 are presented under Primary Outcome Measures.
Day 0, Day 182 and Day 364
Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
기간: At Day 42, Day 182, Day 192 and Day 364
Mean Geometric Change is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer (i.e. post-vaccination divided by pre-vaccination titer).
At Day 42, Day 182, Day 192 and Day 364
Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain
기간: Day 182 and Day 364
Mean Geometric Change is defined as the geometric mean of the within-subject ratios of the post vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer (i.e. post-vaccination divided by pre-vaccination titer). Data for Day 192 are presented under Primary Outcome Measures.
Day 182 and Day 364
Number of Booster Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
기간: At Day 192 and Day 364
Booster seroconversion is defined as follows: For seronegative subjects at pre-booster (Day 182), antibody titer ≥1:40 at post-booster time point(s). For seropositive subjects at pre-booster (Day 182), antibody titer at post-booster time point(s) ≥4-fold the pre-booster antibody titer.
At Day 192 and Day 364
Booster Factor in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
기간: At Day 192 and Day 364
Booster Factor was defined as the geometric mean of the within-subject ratios of the post-booster vaccination reciprocal HI titer to the pre-booster (Day 182) reciprocal titer.
At Day 192 and Day 364
Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
기간: Day 0, Day 42, Day 182, Day 192 and Day 364
A seropositive subject is defined as a subject with serum neutralizing antibody titers ≥ 1:28
Day 0, Day 42, Day 182, Day 192 and Day 364
Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
기간: Day 0, Day 182, Day 192 and Day 364
A seropositive subject is defined as a subject with serum neutralizing antibody titers ≥ 1:28.
Day 0, Day 182, Day 192 and Day 364
Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
기간: Day 0, Day 42, Day 182, Day 192 and Day 364
Titers were presented as geometric mean titers (GMTs).
Day 0, Day 42, Day 182, Day 192 and Day 364
Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
기간: Day 0, Day 182, Day 192 and Day 364
Titers were presented as geometric mean titers (GMTs).
Day 0, Day 182, Day 192 and Day 364
Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
기간: At Day 42, Day 182, Day 192 and Day 364
Vaccine response is defined as: For initially seronegative subjects, neutralizing antibody titer ≥ 1:56 at the considered time point after vaccination For initially seropositive subjects, neutralizing antibody titer ≥ 4 fold from pre-vaccination (Day 0)
At Day 42, Day 182, Day 192 and Day 364
Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
기간: At Day 182, Day 192 and Day 364
Vaccine response is defined as: For initially seronegative subjects, neutralizing antibody titer ≥ 1:56 at the considered time point after vaccination For initially seropositive subjects, neutralizing antibody titer ≥ 4 fold from pre-vaccination (Day 0)
At Day 182, Day 192 and Day 364
Number of Subjects With a Booster Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
기간: At Day 192 and Day 364
Booster vaccine response is defined as: For seronegative subjects at Day 182, neutralizing antibody titers ≥ 1:56 at the considered time point after vaccination For seropositive subjects at Day 182, neutralizing antibody titers ≥ 4 fold from pre-vaccination (Day 182)
At Day 192 and Day 364
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
기간: During the 7-day post-vaccination period following each dose and across doses (Day 0 - Day 7, Day 21 - Day 28, Day 182 - Day 189)
Solicited local symptoms assigned were pain, swelling and redness. Any was defined as occurrence of any local symptom regardless of intensity grade; Grade 3 pain was defined as cried when limb was moved spontaneously painful.
During the 7-day post-vaccination period following each dose and across doses (Day 0 - Day 7, Day 21 - Day 28, Day 182 - Day 189)
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
기간: During the 7-day post-vaccination period following each dose and across doses (Day 0 - Day 7, Day 21 - Day 28, Day 182 - Day 189)
Solicited general symptoms assessed were diarrhoea/ vomiting, drowsiness, irritability/ fussiness, loss of appetite, fever (axillary). Any= occurrence of any general symptom regardless of intensity grade and relationship to the vaccine. Irritability/ fussiness grade 3=crying that could not be comforted/ prevented normal activity; Drowsiness grade 3= drowsiness that prevented normal activity; Loss of appetite grade 3= did not eat at all; Diarrhoea/ vomiting grade 3= diarrhoea/ vomiting that prevented normal activity; Related= general symptom assessed by the investigator as causally related to the study vaccination.
During the 7-day post-vaccination period following each dose and across doses (Day 0 - Day 7, Day 21 - Day 28, Day 182 - Day 189)
Number of Subjects With Medically-attended Events (MAEs)
기간: During the entire study period (from Day 0 to Day 364)
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Analysis of intensity and relationship to vaccination of MAEs was not performed.
During the entire study period (from Day 0 to Day 364)
Number of Subjects With Potential Immune-mediated Disease (pIMDs)
기간: During the entire study period (from day 0 to Day 364)
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
During the entire study period (from day 0 to Day 364)
Number of Subjects With Unsolicited Adverse Events (AEs)
기간: During a 21 day follow-up period after each vaccination (Day 0 - Day 21, Day 21 - Day 42, Day 182 - Day 203)
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" was defined as an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. "Grade 3" was defined as an AE which prevented normal, everyday activities. "Related" was defined as an AE assessed by the investigator as causally related to the study vaccination.
During a 21 day follow-up period after each vaccination (Day 0 - Day 21, Day 21 - Day 42, Day 182 - Day 203)
Number of Subjects With Unsolicited Adverse Events (AEs)
기간: During an 84 day follow-up period after each vaccination (Day 0 - Day 84, Day 21 - Day 105, Day 182 - Day 266)
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" was defined as an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. "Grade 3" was defined as an AE which prevented normal, everyday activities. "Related" was defined as an AE assessed by the investigator as causally related to the study vaccination.
During an 84 day follow-up period after each vaccination (Day 0 - Day 84, Day 21 - Day 105, Day 182 - Day 266)
Number of Subjects With Serious Adverse Events (SAEs)
기간: During the entire study period (from Day 0 to 364)
Serious adverse events (SAEs) assessed included medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity.
During the entire study period (from Day 0 to 364)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

GlaxoSmithKline

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

유용한 링크

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)

2011년 4월 18일

기본 완료 (실제)

2012년 6월 22일

연구 완료 (실제)

2012년 11월 2일

연구 등록 날짜

최초 제출

2011년 3월 24일

QC 기준을 충족하는 최초 제출

2011년 3월 24일

처음 게시됨 (추정)

2011년 3월 28일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 5월 7일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 4월 24일

마지막으로 확인됨

2019년 4월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 109825
  • 2011-004734-33 (EudraCT 번호)

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. 주석이 달린 사례 보고서 양식
    정보 식별자: 109825
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  2. 임상 연구 보고서
    정보 식별자: 109825
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  3. 개별 참가자 데이터 세트
    정보 식별자: 109825
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  4. 연구 프로토콜
    정보 식별자: 109825
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  5. 통계 분석 계획
    정보 식별자: 109825
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  6. 정보에 입각한 동의서
    정보 식별자: 109825
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  7. 데이터 세트 사양
    정보 식별자: 109825
    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. .

GSK Biologicals' investigational vaccine GSK1562902A에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Djibouti

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다