Safety, and Immunogenicity of Two Influenza Vaccines in Healthy Subjects 3 to 64 Years Old
2015年9月16日 更新者：Novartis
A Phase III, Observer-Blind, Randomized, Controlled, Multicenter Study to Evaluate Safety, Tolerability, and Immunogenicity of Two Trivalent Subunit Inactivated Influenza Vaccines in Healthy Children Aged 3 to 8 Years, in Healthy Children/Adolescents Aged 9 to 17 Years,and in Healthy Adults Aged 18 to 64 Years
This protocol is designed to evaluate safety, clinical tolerability and immunogenicity of the 2007 southern hemisphere formulation of a Novartis conventional influenza vaccine licensed in the EU and many other worldwide countries, according to the US FDA Draft Guidance for Industry "Clinical data needed to support the licensure of trivalent inactivated influenza vaccine", issued in March 2006, and to evaluate safety, clinical tolerability and immunogenicity of the 2007 southern hemisphere formulation of a Novartis conventional influenza vaccine already licensed in US.
The purpose of the control arm is primarily to provide a comparative assessment for safety, not immunogenicity or effectiveness.
調査の概要
研究の種類
介入
入学 (実際)
1893
段階
- フェーズ 3
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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Buenos Aires、アルゼンチン
- Site 2: C1425AWK
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Cordoba、アルゼンチン
- Site 1: X5000BJH
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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年～64年 (子、大人)
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
説明
Inclusion Criteria:
- Healthy subjects 3 to 64 years of age
Exclusion Criteria:
- Receipt of other investigational products within 3 months or other vacine within 1 month;
- Allergy to eggs, egg products, or any other vaccine component;
- Laboratory confirmed influenza disease within 6 months;
- Have previously received an influenza vaccination (3 to 8 years only);
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
- 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
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Influenza virus vaccine
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Two intramuscular injections of the investigational influenza virus vaccine administered 4 weeks part to group 3 to 8 years of age while one injection was administered to groups 9 to 17 years of age and 18 to 64 years of age.
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アクティブコンパレータ：Comparator influenza vaccine
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Two intramuscular injections were administered 4 weeks apart to group 3 to 8 years of age while one injection was administered to groups 9 to 17 years of age and 18 to 64 years of age.
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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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Percentage of Subjects With Seroprotection, in Healthy Adults 18 to 64 Years of Age
時間枠：21 days after vaccination
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To evaluate immunogenicity, measured by seroprotection (percentage of subjects achieving a hemagglutination inhibition [HI] titer ≥40) after one injection of the investigational influenza virus vaccine, administered to healthy adults 18 to 64 years of age.
The CBER Guidance states that the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroprotection meet or exceed 70%.
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21 days after vaccination
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Percentage of Subjects Achieving a Seroconversion Rate, in Adults 18 to 64 Years of Age
時間枠：21 days after vaccination
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Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum [HI<10]/ post-vaccination HI titer ≥40) or significant increase defined as at least a 4-fold increase).
According to the CBER Guidance, the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconverion/significant increase meet or exceed 40%.
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21 days after vaccination
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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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Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of Age
時間枠：7 days after vaccination
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Solicited local and systemic reactions were assessed after vaccination in adults 18 to 64 years of age.
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7 days after vaccination
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Percentage of Subjects With Seroprotection, in Healthy Children/Adolescents 9 to 17 Years of Age
時間枠：21 days after vaccination
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To descriptively evaluate immunogenicity, measured by seroprotection rate (percentage of subjects achieving a hemagglutination inhibition [HI] titer ≥40) after one injection of investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age.
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21 days after vaccination
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Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children/Adolescents 9 to 17 Years of Age
時間枠：21 days after vaccination
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Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum [HI<10]/ post-vaccination HI titer ≥40) or significant increase (defined as at least a 4-fold increase) after one injection of the investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age.
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21 days after vaccination
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Geometric Mean Titers (GMTs), in Healthy Children/Adolescents 9 to 17 Years of Age
時間枠：21 days after vaccination
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To evaluate immunogenicity measured by GMTs after one injection of investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age.
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21 days after vaccination
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Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of Age
時間枠：7 days after vaccination
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Solicited local and systemic reactions were assessed after vaccination in children/adolescents 9 to 17 years of age.
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7 days after vaccination
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Percentage of Subjects With Seroprotection, in Healthy Children 3 to 8 Years of Age
時間枠：50 days after last vaccination
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To descriptively evaluate immunogenicity, measured by seroprotection rate (percentage of subjects achieving a hemagglutination inhibition [HI] titer ≥40) after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age.
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50 days after last vaccination
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Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children 3 to 8 Years of Age
時間枠：50 days after last vaccination
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Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum [HI<10]/ post-vaccination HI titer ≥40) or significant increase (defined as at least a 4-fold increase) after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age.
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50 days after last vaccination
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Geometric Mean Titers (GMTs), in Healthy Children 3 to 8 Years of Age
時間枠：50 days after last vaccination
|
To evaluate immunogenicity measured by GMTs after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age.
|
50 days after last vaccination
|
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Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.
時間枠：7 days after each vaccination
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Solicited local and systemic reactions were assessed after each vaccination, in healthy children 3 to 8 years of age.
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7 days after each vaccination
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Geometric Mean Titers (GMTs), in Healthy Adults 18 to 64 Years of Age
時間枠：21 days after vaccination
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Immunogenicity measured by GMTs after one injection of the investigational influenza virus vaccine, in healthy adults 18 to 64 years of age.
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21 days after vaccination
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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
2007年4月1日
一次修了 (実際)
2007年7月1日
研究の完了 (実際)
2007年12月1日
試験登録日
最初に提出
2007年4月23日
QC基準を満たした最初の提出物
2007年4月23日
最初の投稿 (見積もり)
2007年4月24日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年10月1日
QC基準を満たした最後の更新が送信されました
2015年9月16日
最終確認日
2015年9月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- V71P5
- IND: 13299
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