Prevenar (PCV-7) Post-Licensure Safety Study In Russia
2012年7月26日 更新者：Pfizer
Prevenar Post-Licensure Safety Study in Russia: Frequency Of Fever Post Vaccination
This study is planned to monitor the local and/or systemic reactions and compatibility of PCV-7 with routine vaccines in the Russian National immunization schedule. Consistent with the observational nature of this protocol, Prevenar will be administered as standard of care.
The aim of this study is to estimate the incidence of febrile reactions more than 38.0 degrees Celsius, specifically (≥38 to < 39 degrees C; > 39 to < 40 degrees C and > 40 degrees C, and the frequency of other local or systemic reactions following vaccination with Prevenar (PCV-7) co-administered with other routine childhood vaccines under the conditions of routine daily use in the Russian Federation.
調査の概要
研究の種類
観察的
入学 (実際)
100
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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-
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Moscow、ロシア連邦、119049
- Russian State Medical University
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Moscow、ロシア連邦、119296
- Russian Academy of Medical Sciences
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Saint Petersburg、ロシア連邦、197022
- Research Institute of Childhood Infections
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Yekaterinburg、ロシア連邦、620085
- City Children's Clinical Hospital #8
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
3ヶ月～1年 (子)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
Infants and Children from 3 months to 23 months at enrollment
説明
Inclusion Criteria:
- Infants eligible for Prevenar vaccination according to the Regulatory approved terms of the marketing authorization in the Russian Federation:
- Infants from 3 months up to 23 months of age who may benefit from active immunization against disease caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (including sepsis, meningitis, pneumonia, bacteraemia and acute otitis media).
- Parents or legal guardians willing and able to complete the diary cards.
Exclusion Criteria:
- Hypersensitivity to the active substances or to any of the excipients;
- Hypersensitivity to diphtheria toxoid;
- Age less than 3 months or greater than or equal to 2 years at enrollment;
- Contraindications as listed in the Package Insert / Russian SmPC for either Prevenar or for any concomitantly used other vaccines;
- Previously vaccinated with 23-valent pneumococcal polysaccharide vaccine;
- Prophylactic use of non-steroidal anti-inflammatory medications and/or acetaminophen (e.g., paracetamol). However, acetaminophen/paracetamol may be administered for treatment of fever, pain, etc.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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 |
|---|---|
|
healthy children after vaccination
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Non-interventional observational study
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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 |
|---|---|---|
|
Percentage of Participants With Febrile Reactions Post-dose 1
時間枠：Day 1 to Day 3 post-dose 1
|
Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children.
Fever was defined as a temperature of greater than or equal to (>=) 38 degrees Celsius (C).
Percentage of participants with febrile reaction of >=38 degrees C to less than or equal to (<=) 39 degrees C, >39 degrees C to <=40 degrees C and >40 degrees C were observed.
|
Day 1 to Day 3 post-dose 1
|
|
Percentage of Participants With Febrile Reactions Post-dose 2
時間枠：Day 1 to Day 3 post-dose 2
|
Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children.
Fever was defined as a temperature of >=38 degrees C. Percentage of participants with febrile reaction of >=38 degrees C to <=39 degrees C was observed.
|
Day 1 to Day 3 post-dose 2
|
|
Percentage of Participants With Febrile Reactions Post-dose 3
時間枠：Day 1 to Day 3 post-dose 3
|
Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children.
Fever was defined as a temperature of >=38 degrees C. Percentage of participants with febrile reaction of >=38 degrees C to <=39 degrees C was observed.
|
Day 1 to Day 3 post-dose 3
|
|
Percentage of Participants With Febrile Reactions Post-dose 4
時間枠：Day 1 to Day 3 post-dose 4
|
Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children.
Fever was defined as a temperature of >=38 degrees C. Percentage of participants with febrile reaction of >=38 degrees C was observed.
|
Day 1 to Day 3 post-dose 4
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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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Percentage of Participants With Pre-Specified Local Reactions Post-dose 1
時間枠：Day 1 to Day 3 post-dose 1
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Local reactions were reported using an electronic diary.
Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement).
Induration and redness were scaled as Any (induration or redness present); Mild (<2.5 centimeters [cm]); Moderate (>=2.5 cm to <5.0 cm); Severe (>=5.0 cm).
Participants may be represented in more than 1 category.
Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth.
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Day 1 to Day 3 post-dose 1
|
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Percentage of Participants With Pre-Specified Local Reactions Post-dose 2
時間枠：Day 1 to Day 3 post-dose 2
|
Local reactions were reported using an electronic diary.
Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement).
Induration and redness were scaled as Any (induration or redness present); Mild (<2.5 cm); Moderate (>=2.5 cm to <5.0 cm); Severe (>=5.0 cm).
Participants may be represented in more than 1 category.
Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth.
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Day 1 to Day 3 post-dose 2
|
|
Percentage of Participants With Pre-Specified Local Reactions Post-dose 3
時間枠：Day 1 to Day 3 post-dose 3
|
Local reactions were reported using an electronic diary.
Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement).
Induration and redness were scaled as Any (induration or redness present); Mild (<2.5 cm); Moderate (>=2.5 cm to <5.0 cm); Severe (>=5.0 cm).
Participants may be represented in more than 1 category.
Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth.
|
Day 1 to Day 3 post-dose 3
|
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Percentage of Participants With Pre-Specified Local Reactions Post-dose 4
時間枠：Day 1 to Day 3 post-dose 4
|
Local reactions were reported using an electronic diary.
Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement).
Induration and redness were scaled as Any (induration or redness present); Mild (<2.5 cm); Moderate (>=2.5 cm to <5.0 cm); Severe (>=5.0 cm).
Participants may be represented in more than 1 category.
Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth.
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Day 1 to Day 3 post-dose 4
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Percentage of Participants With Pre-Specified Systemic Events Post-dose 1
時間枠：Day 1 to Day 3 post-dose 1
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Systemic events (any fever >=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary.
Participants may be represented in more than 1 category.
|
Day 1 to Day 3 post-dose 1
|
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Percentage of Participants With Pre-Specified Systemic Events Post-dose 2
時間枠：Day 1 to Day 3 post-dose 2
|
Systemic events (any fever >=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary.
Participants may be represented in more than 1 category.
|
Day 1 to Day 3 post-dose 2
|
|
Percentage of Participants With Pre-Specified Systemic Events Post-dose 3
時間枠：Day 1 to Day 3 post-dose 3
|
Systemic events (any fever >=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary.
Participants may be represented in more than 1 category.
|
Day 1 to Day 3 post-dose 3
|
|
Percentage of Participants With Pre-Specified Systemic Events Post-dose 4
時間枠：Day 1 to Day 3 post-dose 4
|
Systemic events (any fever >=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary.
Participants may be represented in more than 1 category.
|
Day 1 to Day 3 post-dose 4
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2009年12月1日
一次修了 (実際)
2011年8月1日
研究の完了 (実際)
2011年8月1日
試験登録日
最初に提出
2010年9月21日
QC基準を満たした最初の提出物
2010年9月21日
最初の投稿 (見積もり)
2010年9月23日
学習記録の更新
投稿された最後の更新 (見積もり)
2012年8月31日
QC基準を満たした最後の更新が送信されました
2012年7月26日
最終確認日
2012年7月1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。