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

Safety and Immunogenicity of a Booster Dose of GSK Biological's Boostrix-Polio Vaccine

2018년 4월 27일 업데이트: GlaxoSmithKline

Evaluation of GSK Biological's dTpa-IPV Booster Vaccine in Children and Adolescents, 5 Years After Previous dTpa-IPV Boosting.

Subjects aged 9 to 13 years who participated in the 711866/001 study 5 years ago will be evaluated for immune persistence and will receive a combined dTpa-IPV booster dose that will be evaluated in terms of immunogenicity, safety and reactogenicity.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

415

단계

  • 4단계

연락처 및 위치

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

연구 장소

  • 독일
      • Berlin, 독일, 12627
        • GSK Investigational Site
      • Berlin, 독일, 13507
        • GSK Investigational Site
      • Berlin, 독일, 13355
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Ettenheim, Baden-Wuerttemberg, 독일, 77955
        • GSK Investigational Site
      • Kehl, Baden-Wuerttemberg, 독일, 77694
        • GSK Investigational Site
      • Oberkirch, Baden-Wuerttemberg, 독일, 77704
        • GSK Investigational Site
      • Offenburg, Baden-Wuerttemberg, 독일, 77654
        • GSK Investigational Site
    • Bayern
      • Cham, Bayern, 독일, 93413
        • GSK Investigational Site
      • Kaufering, Bayern, 독일, 86916
        • GSK Investigational Site
      • Landshut, Bayern, 독일, 84032
        • GSK Investigational Site
      • Muenchen, Bayern, 독일, 80939
        • GSK Investigational Site
      • Olching, Bayern, 독일, 82140
        • GSK Investigational Site
      • Weilheim, Bayern, 독일, 82362
        • GSK Investigational Site
    • Hessen
      • Eschwege, Hessen, 독일, 37269
        • GSK Investigational Site
      • Koenigstein, Hessen, 독일, 61462
        • GSK Investigational Site
    • Niedersachsen
      • Salzgitter, Niedersachsen, 독일, 38226
        • GSK Investigational Site
      • Wolfenbuettel, Niedersachsen, 독일, 38302
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Erkrath, Nordrhein-Westfalen, 독일, 40699
        • GSK Investigational Site
      • Goch, Nordrhein-Westfalen, 독일, 47574
        • GSK Investigational Site
      • Guetersloh, Nordrhein-Westfalen, 독일, 33332
        • GSK Investigational Site
      • Heiligenhaus, Nordrhein-Westfalen, 독일, 42579
        • GSK Investigational Site
      • Kleve-Materborn, Nordrhein-Westfalen, 독일, 47533
        • GSK Investigational Site
      • Krefeld, Nordrhein-Westfalen, 독일, 47798
        • GSK Investigational Site
      • Loehne, Nordrhein-Westfalen, 독일, 32584
        • GSK Investigational Site
      • Muenster, Nordrhein-Westfalen, 독일, 48159
        • GSK Investigational Site
      • Willich, Nordrhein-Westfalen, 독일, 47877
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Bad Kreuznach, Rheinland-Pfalz, 독일, 55543
        • GSK Investigational Site
      • Frankenthal, Rheinland-Pfalz, 독일, 67227
        • GSK Investigational Site
      • Mainz, Rheinland-Pfalz, 독일, 55131
        • GSK Investigational Site
      • Trier, Rheinland-Pfalz, 독일, 54294
        • GSK Investigational Site
      • Worms, Rheinland-Pfalz, 독일, 67547
        • GSK Investigational Site
      • Worms, Rheinland-Pfalz, 독일, 67549
        • GSK Investigational Site
    • Sachsen
      • Dresden, Sachsen, 독일, 01307
        • GSK Investigational Site
      • Dresden, Sachsen, 독일, 01169
        • GSK Investigational Site
    • Schleswig-Holstein
      • Brunsbuettel, Schleswig-Holstein, 독일, 25541
        • GSK Investigational Site
      • Flensburg, Schleswig-Holstein, 독일, 24937
        • GSK Investigational Site
      • Flensburg, Schleswig-Holstein, 독일, 24939
        • GSK Investigational Site
      • Flensburg, Schleswig-Holstein, 독일, 24943
        • 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

9년 (어린이)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Subjects who the investigator believes that they or their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
  • A male or female subject who received a booster vaccination with dTpa-IPV or dTpa + IPV in study 711866/001.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Females of childbearing potential at the time of study entry must have a negative pregnancy test prior to administration of the dose of vaccine and are required to be abstinent or to use adequate contraceptive precautions for one month prior to vaccination. Subjects are required to agree to continue such precautions for two months after vaccination.
  • Written informed consent obtained from both parents/ guardians of the subject; assent from the subject himself/herself should also be requested whenever possible.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressant or other immune-modifying drugs within six months prior to the booster dose.
  • Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during 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.
  • Previous booster vaccination against tetanus, diphtheria, pertussis, or poliomyelitis since the booster dose received in study 711866/001.
  • History of diphtheria, tetanus, pertussis, or poliomyelitis diseases.
  • Any confirmed or suspected immunosuppressive or immunodeficiency condition, based on medical history and physical examination.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Administration of immunoglobulin and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
  • Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.
  • Occurrence of any of the following adverse events (AEs) after a previous administration of a DTP vaccine: hypersensitivity reaction to any component of the vaccine, encephalopathy of unknown aetiology occurring within 7 days following previous vaccination with pertussis-containing vaccine, fever ≥ 40°C within 48 hours of vaccination not due to another identifiable cause, collapse or shock-like state within 48 hours of vaccination
  • Persistent, severe, inconsolable screaming or crying lasting >3 hours occurring within 48 hours of receipt of a previous dose of DTP vaccine convulsions with or without fever, occurring within 3 days of vaccination.
  • Acute disease at the time of enrolment.
  • Pregnant or lactating female.

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: BOOSTRIX-POLIO GROUP
Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
생물학적: Boostrix-Polio
A single booster dose of dTpa-IPV vaccine will be administered to all subjects. IM administration in the deltoid muscle of the non-dominant arm.
실험적: BOOSTRIX + IPV MÉRIEUX GROUP
Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™ and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
생물학적: Boostrix-Polio
A single booster dose of dTpa-IPV vaccine will be administered to all subjects. IM administration in the deltoid muscle of the non-dominant arm.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of Subjects With Any Grade 3 Solicited Local Symptoms
기간: During the 4-day (Days 0-3) follow-up period after booster vaccination
Assessed solicited local symptoms were pain, redness and swelling. Grade 3 Pain: Pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
During the 4-day (Days 0-3) follow-up period after booster vaccination

2차 결과 측정

결과 측정
측정값 설명
기간
요청된 국소 증상이 있는 피험자의 수
기간: 추가 접종 후 4일(Days 0-3) 추적 기간 동안
평가된 요청된 국소 증상은 통증, 발적 및 부종이었습니다. Any = 강도 등급에 관계없이 증상의 발생.
추가 접종 후 4일(Days 0-3) 추적 기간 동안
Number of Subjects With Any Solicited General Symptoms
기간: During the 4-day (Days 0-3) follow-up period after booster vaccination
Assessed solicited general symptoms were fatigue, gastrointestinal, headache and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade and relationship to vaccination.
During the 4-day (Days 0-3) follow-up period after booster vaccination
Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Toxoids
기간: Prior to (Month 0) and one month after (Month 1) booster vaccination
Anti-D and anti-T antibody concnetration greater than or equal to (≥) 0.1 international units per milliliter (IU/mL) and ≥ 1 IU/mL have been assessed by enzyme-linked immunosorbent assay (ELISA). Pre-vaccination sera with ELISA concentrations < 0.1 IU/mL were tested for neutralising antibodies using a Vero-cell neutralisation assay with a 0.016 IU/mL cut-off.
Prior to (Month 0) and one month after (Month 1) booster vaccination
Anti-D and Anti-T Antibody Concentrations
기간: Prior to (Month 0) and one month after (Month 1) booster vaccination
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).
Prior to (Month 0) and one month after (Month 1) booster vaccination
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)
기간: Prior to (Month 0) and one month after (Month 1) booster vaccination
A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 ELISA unit per milliliter (EL.U/ml).
Prior to (Month 0) and one month after (Month 1) booster vaccination
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
기간: Prior to (Month 0) and one month after (Month 1) booster vaccination
Antibodies concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
Prior to (Month 0) and one month after (Month 1) booster vaccination
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens
기간: Prior to (Month 0) and one month after (Month 1) booster vaccination
A seroprotected subject was defined as a subject with anti-Polio type 1, 2 and 3 antibody titers ≥ the value of 8.
Prior to (Month 0) and one month after (Month 1) booster vaccination
Anti-Polio 1, 2 and 3 Antibody Titers
기간: Prior to (Month 0) and one month after (Month 1) booster vaccination
Antibody titers were presented as geometric mean titers (GMTs).
Prior to (Month 0) and one month after (Month 1) booster vaccination
Number of Subjects With Booster Response to Anti-PT, Anti-FHA and Anti-PRN
기간: One month after booster vaccination (At Month 1)
Booster vaccine response was defined as appearance of antibodies in subjects who were seronegative at the pre-vaccination time point (i.e. with concentrations < 5 EL.U/mL) or at least 2-fold increase of pre-vaccination antibody concentrations in subjects who were seropositive at the pre-vaccination time point (i.e. with concentrations < 5 EL.U/mL).
One month after booster vaccination (At Month 1)
Number of Subjects With Unsolicited Adverse Events (AEs)
기간: During the 31-day (Days 0-30) follow-up period after booster vaccination
AEs results are presented for all subjects. 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 and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
During the 31-day (Days 0-30) follow-up period after booster vaccination
Number of Subjects With Serious Adverse Events (SAEs)
기간: During the entire booster period (Month 0 to Month 1)
Assessed SAEs include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
During the entire booster period (Month 0 to 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 (실제)

2008년 2월 1일

기본 완료 (실제)

2008년 7월 8일

연구 완료 (실제)

2008년 7월 8일

연구 등록 날짜

최초 제출

2008년 3월 6일

QC 기준을 충족하는 최초 제출

2008년 3월 6일

처음 게시됨 (추정)

2008년 3월 13일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 6월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 4월 27일

마지막으로 확인됨

2017년 4월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 110947

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: 110947
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  2. 임상 연구 보고서
    정보 식별자: 110947
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  3. 정보에 입각한 동의서
    정보 식별자: 110947
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  4. 개별 참가자 데이터 세트
    정보 식별자: 110947
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  5. 연구 프로토콜
    정보 식별자: 110947
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  6. 통계 분석 계획
    정보 식별자: 110947
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  7. 주석이 달린 사례 보고서 양식
    정보 식별자: 110947
    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. .

구독하다