Immunogenicity and Safety of Inactivated H1N1 Swine-origin Influenza Monovalent Vaccine in Immunocompromised Children and Young Adults
調査の概要
状態
詳細な説明
This is a prospective observational study. This study will not dictate vaccine administration, nor the vaccine product to be used. It will collect data in St Jude patients who will receive the vaccine as part of their clinical care per institutional guidelines. Research participants will receive two doses of inactivated H1N1 swine-origin monovalent influenza vaccine administered 28 days apart as part of clinical care. Each dose contains 15 mcg of hemagglutinin antigen (HA).Follow-up visits will be scheduled 28 days after each dose and at day 208+/- 14 days for blood work. The day of administration of the first vaccine dose is counted as day 0. At each of these visits, blood will be collected to assess for immunogenicity. Research participants will be given a diary card to record symptoms for 28 days . They will be asked to bring this diary back at the next visit. Other vaccine-related adverse events will also be collected by retrospective chart review.
Children and young adults between the ages of 6 months and 21 years and 13 kg or greater in body weight who have an underlying diagnosis of cancer, HIV, sickle cell disease or receipt of a stem cell transplant more than a year prior to study entry and who will receive inactivated H1N1 swine-origin monovalent influenza vaccine in the winter/fall of 2009-2010 as part of their routine clinical care.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Tennessee
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Memphis、Tennessee、アメリカ、38105
- St.Jude Children's Research Hospital
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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 6 months through 21 years of age at the time of entry into the study;
- Body weight of 13 kg or greater at the time of entry into the study;
- Participant is immunocompromised due to cancer, HIV, or sickle cell disease or receipt of a stem cell transplant;
- Participant or participant's parent/legal guardian available by telephone during the course of the study;
- Written informed consent (and assent, if applicable) obtained;
- Potential research participant received or will receive H1N1 swine-origin monovalent influenza vaccine within 24 hours of study entry.
Exclusion Criteria:
- Proven history, by RT-PCR, of H1N1 swine-origin influenza infection prior to study entry;
- Receipt of a stem cell transplant within one year prior to study entry;
- Participation in P1088 study.
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
- 観測モデル：ケースのみ
- 時間の展望：見込みのある
コホートと介入
グループ/コホート |
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H1N1 pandemic influenza vaccine recipient
Children and young adults between the ages of 6 months and 21 years and 13 kg or greater in body weight with underlying conditions of cancer, HIV, sickle cell disease or receipt of a stem cell transplant more than a year prior to study entry and who will receive inactivated H1N1 swine-origin monovalent influenza vaccine in the winter/fall of 2009-2010 as part of their routine clinical care.Target total accrual of up to 400 children and young adults stratified based on their underlying diagnosis as follows: 150 children or young adults with cancer, 100 with human immunodeficiency virus (HIV), 100 with sickle cell disease, and 50 with receipt of a stem cell transplant more than a year prior to study entry.
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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 |
時間枠 |
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This study will document Seroprotection (a post-vaccine antibody response ≥ an HI titer of 1:40).
時間枠：1.5 years
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1.5 years
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二次結果の測定
結果測定 |
時間枠 |
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This study will document seroconversion rates (a 4-fold or greater rise in HI titer comparing pre- and post-vaccine sera).
時間枠：1.5 years
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1.5 years
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協力者と研究者
捜査官
- 主任研究者：Hana Hakim, MD、St. Jude Children's Research Hospital
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
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 (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
本研究に関する用語
キーワード
その他の研究ID番号
- SOVAC
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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。