Study in Toddlers to Demonstrate Non-inferiority of GSK Biologicals' Hib-MenC & to Evaluate Persistence up to 5 Years.
2018년 7월 26일 업데이트: GlaxoSmithKline
Study to Demonstrate Non-inferiority of GSK Biologicals' Hib-MenC With Priorix™, Versus MenC-CRM197 Vaccine With Hiberix™ & Priorix™ in Toddlers Primed With Hib But Not MenC & to Evaluate Persistence up to 5 Years After Vaccination.
The purpose of the primary phase of the study is to demonstrate the non-inferiority of a single dose of GSK Biologicals' Haemophilus influenzae type b and meningococcal C (Hib-MenC) conjugate vaccine when given in the second year of life to subjects primed in infancy with a Hib vaccine, but not with a meningococcal serogroup C vaccine, versus commercially available Hib and MenC vaccines.
In the extension phase, at Years 1, 2, 3, 4 & 5, one blood sample is taken at each year to follow the antibody persistence up to 5 years after vaccination. No additional vaccine is administered during the extension phase. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
연구 개요
상태
완전한
상세 설명
This multicenter study is open and has 2 treatment groups with Hiberix™ + a commercially available MenC vaccine as active controls.
Priorix™ is given concomitantly in both groups.
In the primary phase, two blood samples are taken from all subjects for immunogenicity analyses: before and one month after vaccination.
In the extension phase, at Year 1, 2, 3, 4 & 5, one blood sample is taken at each year to follow the antibody persistence up to 5 years after vaccination.
No additional vaccine is administered during the extension phase.
연구 유형
중재적
등록 (실제)
433
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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Australian Capital Territory
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Garran, Australian Capital Territory, 호주, 2606
- GSK Investigational Site
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New South Wales
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Randwick, New South Wales, 호주, 2031
- GSK Investigational Site
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Westmead, New South Wales, 호주, 2145
- GSK Investigational Site
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Queensland
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Herston, Queensland, 호주, 4029
- GSK Investigational Site
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South Australia
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North Adelaide, South Australia, 호주, 5006
- GSK Investigational Site
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Victoria
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Carlton, Victoria, 호주, 3053
- GSK Investigational Site
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Western Australia
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Perth, Western Australia, 호주
- 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:
Primary phase:
- Subjects whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- A male or female between, and including, 12 and 18 months of age at the time of vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Previously completed routine childhood vaccinations to the best of his/her parents'/guardians knowledge.
- Having completed primary vaccination with two doses of Haemophilus influenzae type b outer membrane protein (Hib-OMP) containing vaccine OR three doses of diphtheria, tetanus, acellular pertussis and Haemophilus influenzae type b (DTPa/Hib) containing vaccine at least 6 months before the study start.
Long-term persistence phase:
- Having participated in the vaccination study 106445
Exclusion Criteria:
For the primary vaccination phase:
- Use of any investigational or non-registered product (drug or vaccine) 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 (defined as more than 14 days) or planned administration of immuno-suppressants or other immune-modifying drugs within six months prior to vaccination.
- Planned administration/administration of a vaccine not foreseen by the protocol during the period starting from 30 days before vaccination and ending 30 days after vaccination.
- Administration of a meningococcal vaccine not foreseen by the study protocol during the period starting at birth and ending at first dose.
- Previous administration of a booster dose of Hib vaccine.
- Previous vaccination against measles, mumps, rubella.
- History of H. influenzae type b, meningococcal serogroup C and/or confirmed measles, mumps or rubella diseases.
- Known exposure to measles, mumps or rubella within 30 days prior to the start of the study.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
- A family history of congenital or hereditary immunodeficiency.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Major congenital defects or serious chronic illness.
- History of neurological disorders or more than one episode of febrile convulsion.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Additional exclusion criteria for the long-term persistence phase: to be checked each year.
- Previous administration of a booster dose of Hib, meningococcal serogroup C vaccines.
- History of H. influenzae type b, meningococcal serogroup C diseases.
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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활성 비교기: Meningitec + Hiberix Group
Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines.
The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
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One subcutaneous dose at 12-18 months of age
One intramuscular dose at 12-18 months of age.
One intramuscular dose at 12-18 months of age
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실험적: Menitorix Group
Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine.
Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
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One subcutaneous dose at 12-18 months of age
One intramuscular dose at 12-18 months of age
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Micrograms Per Milliliter (µg/mL)
기간: 1 month after vaccination
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Anti-PRP antibody concentration greater than or equal to 0.15 µg/mL is indicative of short-term protection.
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1 month after vaccination
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Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Greater Than or Equal to 1:8 Titer
기간: 1 month after vaccination
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rSBA-MenC titers greater than or equal to 1:8 titer are indicative of seroprotection.
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1 month after vaccination
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values
기간: Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination
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rSBA-MenC titers cut-off values assessed were greater than or equal to (≥) 1:8 (indicative of seroprotection) and ≥ 1:128 titers. Functional anti-meningococcal serogroup C activity (SBA-MenC) was determined by a serum bactericidal test using rabbit complement. For SBA testing at a GlaxoSmithKline (GSK) laboratory up to Year 3 after vaccination, titres were expressed as the reciprocal of the dilution resulting in 50% inhibition. For SBA testing at the Public Health England (PHE), formerly known as Health Protection Agency (HPA), at Year 4, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition. |
Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination
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Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values
기간: 5 years after vaccination
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rSBA-MenC titers cut-off values assessed were greater than or equal to (≥)1:8 (indicative of seroprotection) and 1:128 titers.
For SBA testing at the PHE at Year 5, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition.
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5 years after vaccination
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Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers
기간: Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination.
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Titers are given as Geometric Mean Titers (GMTs).
Functional anti-meningococcal serogroup C activity (SBA-MenC) was determined by a serum bactericidal test using rabbit complement.
For SBA testing at a GlaxoSmithKline (GSK) laboratory up to Year 3 after vaccination, titres were expressed as the reciprocal of the dilution resulting in 50% inhibition.
For SBA testing at the PHE at year 4 after vaccination, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition.
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Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination.
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Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers
기간: 5 years after vaccination
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Titers are given as Geometric Mean Titers (GMTs).
Functional anti-meningococcal serogroup C activity (SBA-MenC) was determined by a serum bactericidal test using rabbit complement.
For SBA testing at the PHE at Year 5, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition.
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5 years after vaccination
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Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values
기간: Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination
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Anti-PRP antibody concentration cut-off values assessed include 0.15 µg/mL (indicative of short-term protection) and 1.0 µg/mL (indicative of long-term protection).
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Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination
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Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values
기간: 5 years after vaccination
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Anti-PRP antibody concentration cut-off values assessed include 0.15 µg/mL (indicative of short-term protection) and 1.0 µg/mL (indicative of long-term protection).
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5 years after vaccination
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Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations
기간: Prior to, 1 month , 1 year, 2 years, 3 years and 4 years after vaccination
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Concentrations are given as Geometric Mean Concentrations (GMCs).
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Prior to, 1 month , 1 year, 2 years, 3 years and 4 years after vaccination
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Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations
기간: 5 years after vaccination
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Concentrations are given as Geometric Mean Concentrations (GMCs).
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5 years after vaccination
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Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Above the Cut-off Values
기간: Prior to, 1 month, 1 year, 2 years and 3 years after vaccination
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Anti-PSC antibody concentration cut-off values assessed include greater than or equal to (≥) 0.30 µg/mL and ≥ 2.0 µg/mL.
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Prior to, 1 month, 1 year, 2 years and 3 years after vaccination
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Anti-polysaccharide C (Anti-PSC) Antibody Concentrations
기간: Prior to, 1 month, 1 year, 2 years and 3 years after vaccination
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Concentrations given as Geometric Mean Concentrations (GMCs).
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Prior to, 1 month, 1 year, 2 years and 3 years after vaccination
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Number of Subjects Reporting Solicited Local and General Symptoms
기간: Within 4 days (Day 0 -Day 3) after vaccination
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Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited general symptoms assessed include drowsiness, fever (≥ 38°C), irritability and loss of appetite. |
Within 4 days (Day 0 -Day 3) after vaccination
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Number of Subjects Reporting Unsolicited Symptoms
기간: Within 31 days (Day 0 - Day 30) after vaccination
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Unsolicited symptom: Any adverse event (AE) 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.
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Within 31 days (Day 0 - Day 30) after vaccination
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Number of Subjects Reporting Serious Adverse Events (SAEs)
기간: Throughout the entire study period (up to year 5)
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A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject. For the long-term persistence phase (Years 1 through 5), only those SAEs that are determined by the investigator to have a causal relationship to the vaccination will be described individually. |
Throughout the entire study period (up to year 5)
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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.
일반 간행물
- Booy R, Richmond P, Nolan T, McVernon J, Marshall H, Nissen M, Reynolds G, Ziegler JB, Heron L, Lambert S, Caubet M, Mesaros N, Boutriau D. Immediate and longer term immunogenicity of a single dose of the combined haemophilus influenzae type B-Neisseria meningitidis serogroup C-tetanus toxoid conjugate vaccine in primed toddlers 12 to 18 months of age. Pediatr Infect Dis J. 2011 Apr;30(4):340-2. doi: 10.1097/INF.0b013e31820013d2.
- Booy R, Richmond P, Nolan T, McVernon J, Marshall H, Nissen M, Reynolds G, Ziegler JB, Stoney T, Heron L, Lambert S, Mesaros N, Peddiraju K, Miller JM. Three-year antibody persistence and safety after a single dose of combined haemophilus influenzae type b (Hib)-Neisseria meningitidis serogroup C-tetanus toxoid conjugate vaccine in Hib-primed toddlers. Pediatr Infect Dis J. 2013 Feb;32(2):169-74. doi: 10.1097/INF.0b013e3182787bff.
- Booy R et al. Immunogenicity and safety of the Hib-MenC-TT conjugate vaccine in Hib-primed toddlers: 3 year follow-up. Abstract presented at the 7th World Congress for World Society for Pediatric Infectious Diseases (WSPID). Melbourne, Australia, 16-19 November 2011.
- Booy R et al. Immunogenicity and safety of the Hib-MenC-TT conjugate vaccine in Hib-primed toddlers: 4 year follow-up. Abstract presented at the Communicable Diseases Network Australia - Communicable Diseases Control Conference 2013, Canberra, Australia, 19-20 March 2013.
- Booy R et al. Prolonged immunogenicity and safety of the HibMenC-TT conjugate vaccine in Hib-Primed toddlers. Abstract presented at the PHAA Communicable Disease Conference. Canberra, Australia, 4-6 April 2011.
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
2006년 6월 1일
기본 완료 (실제)
2007년 11월 1일
연구 완료 (실제)
2007년 11월 6일
연구 등록 날짜
최초 제출
2006년 5월 12일
QC 기준을 충족하는 최초 제출
2006년 5월 12일
처음 게시됨 (추정)
2006년 5월 16일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 8월 24일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 7월 26일
마지막으로 확인됨
2016년 9월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 106445
- 106446 (기타 식별자: GSK)
- 106449 (기타 식별자: GSK)
- 106450 (기타 식별자: GSK)
- 106452 (기타 식별자: GSK)
- 106454 (기타 식별자: GSK)
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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통계 분석 계획
정보 식별자: 106445정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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정보에 입각한 동의서
정보 식별자: 106445정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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연구 프로토콜
정보 식별자: 106445정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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데이터 세트 사양
정보 식별자: 106445정보 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: 106445정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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임상 연구 보고서
정보 식별자: 106445정보 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. .