Indirect Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage (FinIPcarr)
Indirect Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage: a FinIP Effectiveness Trial Satellite Study
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Tampere、フィンランド
- National Institute for Health and Welfare
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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)
他の名前：
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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)
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Carriage Due to Any Pneumococcal Serotype
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者：Arto A Palmu, M.D.、Finnish Institute for Health and Welfare
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
PCV GSK1024850Aの臨床試験
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Nagasaki UniversityLondon School of Hygiene and Tropical Medicine; National Institute of Hygiene and Epidemiology... と他の協力者完了
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GlaxoSmithKline完了