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Booster Vaccination Study With a Pneumococcal Vaccine in Children Primed With the Same Vaccine

2018년 8월 21일 업데이트: GlaxoSmithKline

Booster Vaccination With Pneumococcal Vaccine GSK1024850A or Prevenar™ Co-administered With Hiberix™ in Children Primed With the Same Vaccines

The purpose of this study is to evaluate the reactogenicity, safety and immunogenicity of a booster (fourth) dose of pneumococcal vaccine GSK1024850A when co-administered with Hiberix at 12-18 months of age, in children primed with the same vaccines in primary study NCT00680914.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

450

단계

  • 3단계

연락처 및 위치

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

연구 장소

  • 대한민국
      • Ansan, 대한민국, 425-707
        • GSK Investigational Site
      • Bucheon-Si, GyeongGi-do,, 대한민국, 420-767
        • GSK Investigational Site
      • Daejeon, 대한민국, 301-723
        • GSK Investigational Site
      • GyeongSangNam-do, 대한민국, 641-560
        • GSK Investigational Site
      • Gyeonggi-do, 대한민국, 411-706
        • GSK Investigational Site
      • Iksan, 대한민국, 570-711
        • GSK Investigational Site
      • Jeju City, 대한민국, 690-121
        • GSK Investigational Site
      • Jeonju Jeonbuk, 대한민국, 561-712
        • GSK Investigational Site
      • Pusan, 대한민국, 602-739
        • GSK Investigational Site
      • Seoul, 대한민국, 150-719
        • GSK Investigational Site
      • Seoul, 대한민국, 130-702
        • GSK Investigational Site
      • Seoul, 대한민국, 158-710
        • GSK Investigational Site
      • Suwon City, Gyeonggi-do, 대한민국, 442-723
        • GSK Investigational Site
      • Wonju-si Kangwon-do, 대한민국, 220-701
        • 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

1년 (어린이)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

Inclusion Criteria:

  • A male or female between, and including, 12-18 months of age at the time of booster vaccination.
  • Subjects for whom the investigator believes that their parent(s)/ guardian(s) can and will comply with the requirements of the protocol.
  • Subjects who received three doses of pneumococcal conjugate vaccine in study NCT00680914.
  • Written informed consent obtained from the parent(s)/guardian(s) of the child/ward.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the vaccination, or planned use 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 (pharmaceutical product or device).
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
  • Administration of immunoglobulins and/or any blood products within three months preceding the vaccination or planned administration during the study period.
  • Administration of any pneumococcal and/or Hib vaccine since the end of study NCT00680914.
  • Planned administration/administration of a vaccine not allowed by the study protocol during the period starting 1 month (30 days) before the administration of the booster dose of the study vaccines (Visit 1) and up to the follow-up visit (Visit 2) with the exception of vaccines included in the Korean routine immunization which can be given at least one week before the administration of the study vaccines or after study end.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • History of reactions or allergic disease likely to be exacerbated by any component of the study vaccines.
  • Known hypersensitivity to any component of the study vaccines including anaphylactic reactions following the administration of the study vaccines.
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures.
  • Tympanic or axillary/ oral temperature >= 37.5°C or rectal temperature >= 38.0°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.
  • Acute disease 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: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Synflorix Group
Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
생물학적: GSK Biologicals' Synflorix™ (Pneumococcal vaccine GSK1024850A)
Intramuscular injection, administered as a single dose
다른 이름들:
  • Pneumococcal vaccine GSK1024850A
생물학적: GSK Biologicals' Hiberix™
Intramuscular injection, administered as a single dose
다른 이름들:
  • Hib
활성 비교기: Prevenar Group
Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
생물학적: GSK Biologicals' Hiberix™
Intramuscular injection, administered as a single dose
다른 이름들:
  • Hib
생물학적: Wyeth-Lederle's Prevenar™
Intramuscular injection, administered as a single dose

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of Subjects Reporting Grade 3 Adverse Events
기간: Within 31 days (Day 0 - Day 30) after booster vaccination.
Grade 3 adverse events are severe symptoms that prevent normal, everyday activities.
Within 31 days (Day 0 - Day 30) after booster vaccination.

2차 결과 측정

결과 측정
측정값 설명
기간
Number of Subjects Reporting Solicited Symptoms
기간: Within 4 days (Days 0 to 3) after booster vaccination
Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited general symptoms assessed include drowsiness, fever (equal to or above 37.5 degrees Celsius), irritability and loss of appetite.
Within 4 days (Days 0 to 3) after booster vaccination
Number of Subjects Reporting Unsolicited Adverse Events
기간: Within 31 days (Days 0 to 30) after booster vaccination
An unsolicited adverse event is any adverse event (i.e. 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) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
Within 31 days (Days 0 to 30) after booster vaccination
Number of Subjects Reporting Serious Adverse Events
기간: After booster vaccination up to study end (Month 0 to Month 1)
Serious adverse events are 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.
After booster vaccination up to study end (Month 0 to Month 1)
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes
기간: One month after booster vaccination (Month 1)

Concentrations of antibodies are measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations expressed as microgram per milliliter (ug/mL).

Vaccine pneumococcal serotypes included serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
One month after booster vaccination (Month 1)
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
기간: One month after booster vaccination (Month 1)

Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions.

Vaccine pneumococcal serotypes included serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
One month after booster vaccination (Month 1)
Concentration of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A
기간: One month after booster vaccination (Month 1)
Concentrations of antibodies are measured by 22F-inhibition ELISA and are presented as geometric mean concentrations expressed as microgram per milliliter.
One month after booster vaccination (Month 1)
Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A
기간: One month after booster vaccination (Month 1)
Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions.
One month after booster vaccination (Month 1)
Concentration of Antibodies Against Protein D (PD)
기간: One month after booster vaccination (Month 1)
Concentrations of antibodies are presented as geometric mean concentrations expressed as Enzyme-Linked Immuno-Sorbent Assay (ELISA) units per milliliter (EU/mL).
One month after booster vaccination (Month 1)
Concentration of Antibodies Against Polyribosyl-ribitol-phosphate (PRP)
기간: One month after booster vaccination (Month 1)
Concentrations of antibodies are presented as geometric mean concentrations expressed as microgram per milliliter.
One month after booster vaccination (Month 1)

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

2009년 6월 11일

기본 완료 (실제)

2010년 1월 11일

연구 완료 (실제)

2010년 1월 11일

연구 등록 날짜

최초 제출

2009년 5월 28일

QC 기준을 충족하는 최초 제출

2009년 5월 28일

처음 게시됨 (추정)

2009년 6월 1일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 9월 20일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 8월 21일

마지막으로 확인됨

2016년 10월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 112933

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. 정보에 입각한 동의서
    정보 식별자: 112933
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  2. 데이터 세트 사양
    정보 식별자: 112933
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  3. 개별 참가자 데이터 세트
    정보 식별자: 112933
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  4. 주석이 달린 사례 보고서 양식
    정보 식별자: 112933
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  5. 연구 프로토콜
    정보 식별자: 112933
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  6. 통계 분석 계획
    정보 식별자: 112933
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  7. 임상 연구 보고서
    정보 식별자: 112933
    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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