Immunogenicity and Safety of Booster Dose of PoliorixTM Vaccine in Previously Vaccinated Toddlers
2018년 9월 18일 업데이트: GlaxoSmithKline
Immunogenicity and Safety of a Booster Dose of GlaxoSmithKline Biologicals' IPV (PoliorixTM) in Healthy Chinese Toddlers
This study aims to evaluate the persistence of anti-poliovirus antibodies in toddlers aged 18 months who were primed with oral polio vaccine (OPV) or inactivated polio vaccine (IPV) in the primary study.
The study will also assess the immunogenicity and reactogenicity of a booster dose of IPV in subjects primed with three doses of IPV.
연구 개요
상세 설명
All subjects will also receive a booster dose of GSK Biologicals' DTPa/Hib vaccine (Infanrix+Hib) at Day 0. This vaccine will be provided as part of the local standard of care and will not be associated with any study endpoint.
연구 유형
중재적
등록 (실제)
957
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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Mengshan Town, 중국
- GSK Investigational Site
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Guangxi
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Wuzhou, Guangxi, 중국
- 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
1년 (어린이)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
- Subjects who received the complete three-dose primary vaccination course in study NCT01021293.
- Healthy male or female toddlers 18 to 24 months of age at the time of Visit 1 (Day 0).
- 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.
Exclusion Criteria:
- Child in care.
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the booster dose of study vaccine(s), or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to Visit 1 (Day 0).
- Administration of immunoglobulins and/or any blood products within the 3 months preceding Visit 1 (Day 0) or planned administration during the study period.
- Administration of a vaccine not foreseen by the study protocol within 30 days of Visit 1 (Day 0) or planned administration during the study period.
- 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.
- Evidence of previous booster vaccination against poliomyelitis or the disease since the conclusion visit of Study NCT01021293.
- History of seizures or progressive neurological disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- 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.
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: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Group A
Subjects in this group will receive the GSK Biologicals' IPV vaccine at 18 months of age.
Subjects will also receive a dose of DTPa/Hib (Infanrix+Hib) as part of the local standard of care.
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Single dose, intramuscular administration
Single dose, intramuscular injection.
Part of the local standard of care.
No outcome measures associated.
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활성 비교기: Group B
Subjects in this group will receive only a booster dose of GSK Biologicals' DTPa/Hib vaccine (Infanrix+Hib) as part of the local standard of care and will not be associated with any study endpoint.
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Single dose, intramuscular injection.
Part of the local standard of care.
No outcome measures associated.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value
기간: One month after Poliorix™ booster vaccination.
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A seroprotected subject was defined as a vaccinated subject whose antibody titer is greater than or equal to (≥) 8 Effective Dose 50 (ED50).
This outcome measure concerns subjects in the Poliorix Group only.
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One month after Poliorix™ booster vaccination.
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Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value
기간: Before booster vaccination.
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A seroprotected subject was defined as a vaccinated subject whose antibody titer is greater than or equal to (≥) 8 ED50.
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Before booster vaccination.
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Antibody Titers Against Poliovirus Type 1, 2 and 3
기간: One month after Poliorix™ booster vaccination.
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Antibody titers were summarized by geometric mean titers (GMTs) with their 95% confidence intervals (CIs).
This outcome measure concerns subjects in the Poliorix Group only.
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One month after Poliorix™ booster vaccination.
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Antibody Titers Against Poliovirus Type 1, 2 and 3.
기간: Before booster vaccination.
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Antibody titers were summarized by geometric mean titers (GMTs) with their 95% CIs.
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Before booster vaccination.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Number of Subjects With Any and Grade 3 Solicited Local Symptoms
기간: Within 4-days (Days 0-3) post Poliorix™ booster vaccination.
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Solicited local symptoms assessed were pain, redness and swelling.
Any = occurrence of the symptom regardless of intensity grade.
Grade 3 pain = Cry when limb was moved/spontaneously painful.
Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
This outcome measure concerns subjects in the Poliorix Group only.
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Within 4-days (Days 0-3) post Poliorix™ booster vaccination.
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Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
기간: Within 4-days (Days 0-3) post Poliorix™ booster vaccination.
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Solicited general symptoms assessed include drowsiness, irritability, loss of appetite and fever [defined as axillary temperature ≥ 37.1 degrees Celsius (°C)].
Any = occurence of any general symptom regardless of their intensity grade or relationship to study vaccine.
Grade 3 drowsiness = drowsiness that prevented normal activities.
Grade 3 fever = fever (axillary temperature) >39.0°C.
Grade 3 irritability = crying that could not be comforted/ prevented normal activity.
Grade 3 loss of appetite = not eating at all.
Related = symptom assessed by the investigator as causally related to the vaccination.
This outcome measure concerns subjects in the Poliorix Group only.
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Within 4-days (Days 0-3) post Poliorix™ booster vaccination.
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Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
기간: Within the 31-day (Days 0-30) follow-up period after the Poliorix™ booster vaccination.
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An unsolicited AE covers 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 adverse event (AE) reported in addition to those solicited during the clinical study.
Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
This outcome measure concerns subjects in the Poliorix Group only.
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Within the 31-day (Days 0-30) follow-up period after the Poliorix™ booster vaccination.
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Number of Subjects With Serious Adverse Events (SAEs)
기간: During the entire study period (Day 0 to Month 1).
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Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
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During the entire study period (Day 0 to Month 1).
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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.
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
2011년 4월 25일
기본 완료 (실제)
2011년 9월 19일
연구 완료 (실제)
2011년 9월 19일
연구 등록 날짜
최초 제출
2011년 3월 24일
QC 기준을 충족하는 최초 제출
2011년 3월 24일
처음 게시됨 (추정)
2011년 3월 25일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 2월 11일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 9월 18일
마지막으로 확인됨
2017년 5월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 114306
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
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데이터 세트 사양
정보 식별자: 114306정보 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: 114306정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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임상 연구 보고서
정보 식별자: 114306정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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정보에 입각한 동의서
정보 식별자: 114306정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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통계 분석 계획
정보 식별자: 114306정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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연구 프로토콜
정보 식별자: 114306정보 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. .