Indirect Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage (FinIPcarr)
Indirect Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage: a FinIP Effectiveness Trial Satellite Study
연구 개요
상세 설명
The purpose of this study is to assess the indirect effects of a pneumococcal conjugate vaccine administered to infants on vaccinees' elder non-vaccinated siblings aged 3 to 7 years.
This study includes a cross-sectional sampling of nasopharyngeal and oropharyngeal swabs in 2011 and a register-based follow-up study for invasive disease, hospital-diagnosed pneumonia, tympanostomy tube surgery and outpatient antimicrobial treatment.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Tampere, 핀란드
- National Institute for Health and Welfare
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- age 3 to 7 years
- younger sibling at least 12 months of age living in the same household participates in the FinIP or 053 trial (regardless of the vaccination schedule)
- at least one parent with fluent Finnish
- informed consent from one parent
Exclusion Criteria:
- commercial PCV vaccination administered
- study-related PCV vaccination administered (open or blind)
- history of antimicrobial treatment within 4 weeks (the child can be enrolled later)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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Sibling vaccinated with PCV GSK1024850A
Older sibling of a child vaccinated with Pneumococcal conjugate vaccine GSK1024850A in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380) NOTE: the primary analysis cohort include siblings of the PCV-vaccinated according to infant schedules (excluding siblings of catch-up vaccinated children) |
2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov
Identifier:NCT00861380)
다른 이름들:
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Control-vaccinated sibling
Older sibling of a child vaccinated with control vaccine (hepatitis B vaccine or hepatitis A vaccine) in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380) NOTE: the primary analysis cohort include siblings of the PCV-vaccinated according to infant schedules (excluding siblings of catch-up vaccinated children) |
2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov
Identifier:NCT00861380)
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Carriage Due to Any Pneumococcal Serotype Included in the Ten-valent Pneumococcal Conjugate Vaccine (PCV10) Vaccine in Older Siblings of Children Vaccinated With Infant Schedules
기간: one sampling at 3 to 7 years of age
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Carriage due to any pneumococcal serotype included in the ten-valent pneumococcal conjugate vaccine (PCV10) vaccine in older siblings of children vaccinated with infant schedules.
Nasopharyngeal swabs taken once at 3 to 7 years of age when the vaccinated sibling is at least 12 months of age
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one sampling at 3 to 7 years of age
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Carriage Due to Any Pneumococcal Serotype
기간: one sampling at 3 to 7 years of age
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Nasopharyngeal and oropharyngeal swabs taken once at 3 to 7 years of age when the vaccinated sibling is at least 12 months of age
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one sampling at 3 to 7 years of age
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Carriage Due to Haemophilus Influenzae
기간: one sampling at 3 to 7 years of age
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Nasopharyngeal and oropharyngeal swabs taken once at 3 to 7 years of age when the vaccinated sibling is at least 12 months of age
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one sampling at 3 to 7 years of age
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Invasive Pneumococcal Disease
기간: Up to 8 years
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Register follow-up up to 8 years after the vaccination of the younger sibling in the family
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Up to 8 years
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Hospital-diagnosed Pneumonia
기간: Up to 8 years
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Register follow-up up to 8 years after the vaccination of the younger sibling in the family
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Up to 8 years
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Tympanostomy Tube Surgery
기간: Up to 8 years
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Register follow-up up to 8 years after the vaccination of the younger sibling in the family
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Up to 8 years
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Outpatient Antibiotic Treatment
기간: Up to 8 years
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Register follow-up up to 8 years after the vaccination of the younger sibling in the family
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Up to 8 years
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공동 작업자 및 조사자
스폰서
협력자
수사관
- 수석 연구원: Arto A Palmu, M.D., Finnish Institute for Health and Welfare
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- THL/1843/6.02.01/2010
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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. .
PCV GSK1024850A에 대한 임상 시험
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Nagasaki UniversityLondon School of Hygiene and Tropical Medicine; National Institute of Hygiene and Epidemiology... 그리고 다른 협력자들완전한
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Brazilian Institute of Higher Education of Censa완전한
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Hallym University Medical Center알려지지 않은
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Inventprise Inc.PATH; Canadian Center for Vaccinology; Vaccine Evaluation Center, Canada완전한