Safety, Tolerability and Immunogenicity of an Trivalent Inactivated Cell-Culture Influenza Vaccine in Healthy Adults
2019年3月25日 更新者：SK Chemicals Co., Ltd.
Randomized, Double-blinded, Controlled, Phase I Trial to Assess Safety, Tolerability and Immunogenicity of 'NBP607(Trivalent Inactivated Cell-Culture Influenza Vaccine)' Compared to Egg-based Influenza Vaccine in Healthy Adult
A randomized, double-blinded, controlled, Phase I clinical trial to assess the safety, tolerability and immunogenicity of 'NBP607(trivalent inactivated cell-culture influenza vaccine)' compared to egg-based influenza vaccine in healthy adult volunteers
調査の概要
詳細な説明
- Assessment of Safety
- Assessment of Immunogenicity
- Estimated Enrollment: 100
研究の種類
介入
入学 (実際)
100
段階
- フェーズ 1
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
-
-
Guro-gu
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Seoul、Guro-gu、大韓民国、153-703
- Korea University Guro Hospital
-
-
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
20年～59年 (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:
- 20 to <60 years of age
- able and willing to give written informed consent prior to study entry
- if female, at least 2 years after post- menopausal and negative result of urine-human chorionic gonadotropin (HCG) test at screening
Exclusion Criteria:
- hypersensitivity to any component of the study medication or chemically related substances, such as allergy to eggs or egg products
- Immunodeficiency disease
- history of hypersensitivity when vaccination, such as Guillain-Barre syndrome
- thrombocytopenia or Coagulation disorders
- experienced fever (>37.5°C) within the past 24 hours or any acute respiratory infection
- receipt of Immunosuppressants or Immunomodulators within the past 3 months
- receipt of blood products or immunoglobulin within the past 3 months
- received influenza vaccine within the past 6 months
- received another vaccine within the past 1 month or plans vaccination within 1 months following the study vaccination
- participation on another clinical trial within 1 month prior to the study vaccination
- history of blood donation within 1 week prior to the study vaccination for plan of blood donation within 7 days following the study vaccination
- any chronic diseases that interfere with the clinical trial or Malignant tumors
- pregnant or breastfeeding
- any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives or might interfere with the safety of the study subject.
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：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Group 1
NBP607 0.5ml
|
1 dose, 0.5ml, Intramuscular (IM) injection
|
|
アクティブコンパレータ：Group 2
Agrippal 0.5ml
|
1 dose, 0.5ml, Intramuscular (IM) injection
|
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 |
|---|---|---|
|
Incidence rate of solicited local adverse events (AEs)
時間枠：Within 21 days after vaccination
|
All AEs were classified and analyzed according to its severity and causality.
The number and percentage of subjects with AEs were analyzed.
Incidence rate, 95% confidence interval as well as number of occurrences were calculated.
|
Within 21 days after vaccination
|
|
Incidence rate of solicited systemic AEs
時間枠：Within 21 days after vaccination
|
All AEs were classified and analyzed according to its severity and causality.
The number and percentage of subjects with AEs were analyzed.
Incidence rate, 95% confidence interval as well as number of occurrences were calculated.
|
Within 21 days after vaccination
|
|
Incidence rate of unsolicited AEs
時間枠：Within 21 days after vaccination
|
All AEs were classified and analyzed according to its severity and causality.
The number and percentage of subjects with AEs were analyzed.
Incidence rate, 95% confidence interval as well as number of occurrences were calculated.
|
Within 21 days after vaccination
|
|
Pulse rate at each visit
時間枠：0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
|
Comparisons within each group between pre-/post- vaccination were summarized and presented.
|
0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
|
|
Blood pressure(systolic/diastolic) at each visit
時間枠：0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
|
Comparisons within each group between pre-/post- vaccination were summarized and presented.
|
0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
|
|
Body temperature at each visit
時間枠：0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
|
Comparisons within each group between pre-/post- vaccination were summarized and presented.
|
0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
|
|
Rate of normal/abnormal results in Electrocardiogram (ECG) (ventricular rate, PR interval, QRS, QT, and QTc) collected during screening visit and close-out visit
時間枠：Screening visit(0-14 days prior to vaccination)/close-out visit(21-28 days after vaccination)
|
Comparisons within each group between pre-/post- vaccination were summarized and presented.
|
Screening visit(0-14 days prior to vaccination)/close-out visit(21-28 days after vaccination)
|
|
Rate of normal/abnormal results in physical examination at each visit
時間枠：0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
|
Comparisons within each group between pre-/post- vaccination were summarized and presented.
|
0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
|
|
Rate of normal/abnormal results in clinical laboratory tests(Platelet, Cl, etc.) during screening visit and close-out visit
時間枠：Screening visit(0-14 days prior to vaccination)/close-out visit(21-28 days after vaccination)
|
Comparisons within each group between pre-/post- vaccination were summarized and presented.
|
Screening visit(0-14 days prior to vaccination)/close-out visit(21-28 days after vaccination)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Seroconversion rate measured by pre-/post-vaccination Haemagglutination Inhibition (HI) titer[Immunogenicity]
時間枠：21-28 days after vaccination
|
The proportion of subjects achieving one of the following conditions; i)If the pre-vaccination HI titer were <1:10, subjects achieving an HI titer ≥1:40 after vaccination ii)If the pre-vaccination HI titers were ≥1:10, subjects with a minimum 4-fold rise in HI titer
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21-28 days after vaccination
|
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Geometric Mean Ratio (GMR) measured by pre-/post-vaccination HI titer[Immunogenicity]
時間枠：21-28 days after vaccination
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The mean increase in geometric mean HI titer
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21-28 days after vaccination
|
|
Seroprotection rate measured by post-vaccination HI titer[Immunogenicity]
時間枠：21-28 days after vaccination
|
The proportion of subjects with post-vaccination HI titers of ≥1:40
|
21-28 days after vaccination
|
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
捜査官
- 主任研究者：Woo Joo Kim, Ph.D.、Korea University Guro Hospital
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
2012年9月1日
一次修了 (実際)
2012年10月1日
研究の完了 (実際)
2012年11月1日
試験登録日
最初に提出
2012年12月12日
QC基準を満たした最初の提出物
2019年3月25日
最初の投稿 (実際)
2019年3月28日
学習記録の更新
投稿された最後の更新 (実際)
2019年3月28日
QC基準を満たした最後の更新が送信されました
2019年3月25日
最終確認日
2012年10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
- NBP607_Flu_I_2012
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