Efficacy Trial of Two Pneumococcal Conjugate Vaccines (PncCRM and PncOMPC) for Prevention of Acute Otitis Media Due to Vaccine Serotypes
Efficacy Trial in Finnish Children of Two Pneumococcal Conjugate Vaccines (PncCRM and PncOMPC) for Prevention of Acute Otitis Media Due to Pneumococcal Serotypes in the Vaccines
This was a randomized, double-blinded multicenter cohort study of Finnish children aged 2 to 24 months. The study was designed to evaluate the efficacy of two 7-valent pneumococcal conjugate vaccines (PncCRM and PncOMPC) parallelly, both vaccines compared with the same control vaccine (hepatitis B vaccine).
The primary endpoint was culture-confirmed pneumococcal acute otitis media (AOM) episodes due to all serotypes included in the pneumococcal conjugate vaccine and the primary hypothesis was that, compared to the control vaccine group, the pneumococcal conjugate vaccine would protect infants from culture confirmed AOM caused by pneumococcal serotypes in the vaccine. The efficacy of the two vaccines against any pneumococcal AOM and any AOM was also evaluated.
The children were vaccinated with the pneumococcal conjugate vaccine or the control vaccine at the age of 2, 4, 6 and 12 months and followed at study clinics established specifically for the purpose from 2 to 24 months of age. Whenever AOM was diagnosed during the follow-up, middle ear fluid was aspirated for bacterial culture.
調査の概要
状態
研究の種類
入学
段階
- フェーズ 3
連絡先と場所
研究場所
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Kangasala、フィンランド、36200
- Kangasala Study Clinic
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Nokia、フィンランド、37101
- Nokia Study Clinic
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Tampere、フィンランド、33200
- Eteläinen, Keskinen, and Läntinen Study Clinic
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Tampere、フィンランド、33500
- Itäinen and Pohjoinen Study Clinic
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Tampere、フィンランド、33720
- Kaakkoinen Study Clinic
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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
説明
Inclusion Criteria:
- infants coming to their own child health center before the age of 13 weeks, and judged to be in good health on the basis of medical history and physical examination
- family living permanently in Tampere, Kangasala or Nokia
- at least one of the parents/guardians is able to communicate fluently in Finnish
- written informed consent obtained from a parent/guardian prior to enrollment in the study
Exclusion Criteria:
- hypersensitivity to any of the components of the vaccines used in the study,
- known or suspected impairment of immunologic function,
- history of invasive pneumococcal disease,
- prior vaccination with any pneumococcal vaccine,
- prior vaccination with hepatitis B vaccine,
- contraindications to routine childhood immunizations
- any medical condition in which, in the opinion of the investigator, the study procedures or vaccinations might cause risk to the health or endanger the well-being of the child
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
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
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 |
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Culture-confirmed pneumococcal acute otitis media episodes due to all serotypes included in the pneumococcal conjugate vaccine
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二次結果の測定
結果測定 |
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First episodes of culture-confirmed pneumococcal AOM due to all serotypes included in the pneumococcal conjugate vaccine
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協力者と研究者
捜査官
- 主任研究者：Juhani Eskola, MD、Finnish Institute for Health and Welfare
- スタディディレクター：Terhi Kilpi, MD、Finnish Institute for Health and Welfare
出版物と役立つリンク
一般刊行物
- Eskola J, Kilpi T, Palmu A, Jokinen J, Haapakoski J, Herva E, Takala A, Kayhty H, Karma P, Kohberger R, Siber G, Makela PH; Finnish Otitis Media Study Group. Efficacy of a pneumococcal conjugate vaccine against acute otitis media. N Engl J Med. 2001 Feb 8;344(6):403-9. doi: 10.1056/NEJM200102083440602.
- Kilpi T, Ahman H, Jokinen J, Lankinen KS, Palmu A, Savolainen H, Gronholm M, Leinonen M, Hovi T, Eskola J, Kayhty H, Bohidar N, Sadoff JC, Makela PH; Finnish Otitis Media Study Group. Protective efficacy of a second pneumococcal conjugate vaccine against pneumococcal acute otitis media in infants and children: randomized, controlled trial of a 7-valent pneumococcal polysaccharide-meningococcal outer membrane protein complex conjugate vaccine in 1666 children. Clin Infect Dis. 2003 Nov 1;37(9):1155-64. doi: 10.1086/378744. Epub 2003 Oct 7.
- Ekstrom N, Ahman H, Palmu A, Gronholm S, Kilpi T, Kayhty H; FinOM Study Group. Concentration and high avidity of pneumococcal antibodies persist at least 4 years after immunization with pneumococcal conjugate vaccine in infancy. Clin Vaccine Immunol. 2013 Jul;20(7):1034-40. doi: 10.1128/CVI.00039-13. Epub 2013 May 8.
研究記録日
主要日程の研究
研究開始
研究の完了
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 (見積もり)
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。
7-valent pneumococcal-CRM197 conjugate vaccineの臨床試験
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