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Safety and Immunogenicity of 3 Lots of Cell-derived Subunit Influenza Vaccine as Compared to 1 Lot to Egg-derived Subunit Influenza Vaccine in Healthy Adults (>=18 to <=60)

2019年8月2日 更新者:Novartis Vaccines

A Phase III, Randomized, Controlled, Observer-Blind, Multi-Center Study to Evaluate Safety, Tolerability and Immunogenicity of a Single Intramuscular Dose of Three Lots of a Trivalent Subunit Influenza Vaccine Produced in Mammalian Cell Culture Or of a Trivalent Subunit Influenza Vaccine Produced in Embryonated Hen Eggs, in Healthy Adult Subjects Aged >=18 to <=60

The present study aims to evaluate safety, tolerability and immunogenicity of three lots of Chiron's cell-derived subunit influenza vaccine in healthy adult subjects as compared to a conventional egg-derived control vaccine licensed in Europe.

調査の概要

研究の種類

介入

入学 (実際)

1200

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

      • Panevezys、リトアニア
        • 2nd Department of Internal Diseases, Panevezys Hospital,
      • Vilnius、リトアニア
        • Dept. Infectious Diseases and Microbiology of Vilnius University

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

18年~60年 (大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  1. 18 to <61 years of age
  2. mentally competent to understand the nature, the scope and the consequences of the study
  3. able and willing to give written informed consent prior to study entry
  4. in good health as determined by:

    1. medical history,
    2. physical examination,
    3. clinical judgment of the Investigator.

Exclusion Criteria:

  1. unwilling or unable to give written informed consent to participate in the study
  2. participation in another clinical trial of an investigational agent within 90 days prior to Visit 1 and throughout the entire study
  3. currently experiencing an acute infectious disease
  4. any serious disease, such as, for example:

    1. cancer,
    2. autoimmune disease (including rheumatoid arthritis),
    3. advanced arteriosclerotic disease or complicated diabetes mellitus,
    4. chronic obstructive pulmonary disease (COPD) requiring oxygen therapy,
    5. acute or progressive hepatic disease,
    6. acute or progressive renal disease,
    7. congestive heart failure
  5. surgery planned during the study period
  6. bleeding diathesis
  7. history of hypersensitivity to any component of the study medication or chemically related substances
  8. history of any anaphylaxis, serious vaccine reactions, or allergy to any of the vaccine component
  9. known or suspected impairment/alteration of immune function, for example resulting from:

    1. receipt of immunosuppressive therapy (any corticosteroid therapy or cancer chemotherapy),
    2. receipt of immunostimulants,
    3. receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivates within 3 months prior to Visit 1 or planned during the full length of the study,
    4. high risk for developing an immunocompromising disease
  10. history of drug or alcohol abuse
  11. laboratory-confirmed influenza disease within 6 months prior to Visit 1
  12. receipt of influenza vaccine within 6 months prior to Visit 1
  13. receipt of another vaccine within 60 days prior to Visit 1, or planned vaccination within 3 weeks following study vaccination
  14. any acute respiratory disease or infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) or experienced fever (i.e., axillary temperature ≥ 38 degree C) within 5 days prior to Visit 1
  15. if female, pregnant or breastfeeding
  16. if female, refusal to use a reliable contraceptive method during the three weeks following vaccination
  17. planned relocation abroad during the study period
  18. any condition that, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.

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:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的:cTIV_lot 1
One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 1
実験的:cTIV_lot 2
One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 2
実験的:cTIV_lot 3
One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 3
アクティブコンパレータ:TIV group
One single 0.5ml intramuscular injection of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).

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
Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects
時間枠:Day 22 postvaccination

The haemagglutinin Inhibition (HI) antibody titer response following

  1. one dose of cTIV for each of the three lots separately and
  2. one dose of cTIV (combined) compared to TIV is reported as Geometric mean titers (GMTs).

The HI GMTs were evaluated using egg-derived antigen assay.

Day 22 postvaccination
Geometric Mean Ratios After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects
時間枠:Day 22 postvaccination

Immunogenicity was assessed in terms of Geometric Mean Ratio (GMR) following

  1. one dose of cTIV for each of the three vaccine lots separately and
  2. for one dose of cTIV (combined) compared to TIV, according to the CHMP criterion.

The European licensure (CHMP) criterion is met if the mean geometric increase (GMR, day 22/day 1) in HI antibody titer is >2.5.

Day 22 postvaccination
Percentage of Subjects With HI Titers ≥40
時間枠:Day 22 postvaccination

Immunogenicity was assessed in terms of percentage of adult subjects achieving HI titers ≥40, after

  1. one dose of cTIV for each of the three vaccine lots separately and
  2. for one dose of cTIV (combined) compared to TIV, according to the CHMP criterion.

European Licensure (CHMP) criterion is met if the percentage of subjects achieving HI titers ≥40 is >70%.

Day 22 postvaccination
Percentage of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Either Cell-derived or Egg-derived Subunit Trivalent Influenza Vaccine
時間枠:Day 22 postvaccination

Immunogenicity was assessed in terms of percentage of adult subjects showing seroconversion or significant increase in HI antibody titers after

  1. one dose of cTIV for each of the three vaccine lots separately and
  2. one dose of cTIV (combined) compared to TIV, according to the CHMP criterion.

European Licensure (CHMP) criterion is met if the percentage of subjects achieving seroconversion or significant increase is >40%.

As per European Licensure (CHMP) criterion seroconversion is defined as percentage of subjects with a prevaccination HI titer <10 to a postvaccination titer ≥40; whereas, significant increase is defined as HI titer ≥10 prevaccination and ≥4-fold Hi titer increase post-vaccination.

Day 22 postvaccination

二次結果の測定

結果測定
メジャーの説明
時間枠
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine.
時間枠:Day 1 to Day 7 postvaccination

To assess the safety and tolerability in terms of number of subjects reporting solicited adverse events following one injection of

  1. one dose of cTIV for each of the three vaccine lots separately and
  2. for one dose of cTIV (combined) compared to TIV.
Day 1 to Day 7 postvaccination
Safety Data of Subjects Upto Six Months After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine
時間枠:Day 1 - Day 181 postvaccination
Additional safety data from day 1 through day 181 after one dose of cTIV (combined) or TIV in terms of serious adverse events (SAEs), adverse events (AEs) necessitating a physician's visit and/or resulting in premature subject's withdrawal from study is reported.
Day 1 - Day 181 postvaccination

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

  • スタディチェア:Novartis Vaccines、Novartis Vaccines & Diagnostics

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

2005年9月1日

一次修了 (実際)

2005年10月1日

研究の完了 (実際)

2006年4月1日

試験登録日

最初に提出

2006年4月3日

QC基準を満たした最初の提出物

2006年4月3日

最初の投稿 (見積もり)

2006年4月5日

学習記録の更新

投稿された最後の更新 (実際)

2019年8月15日

QC基準を満たした最後の更新が送信されました

2019年8月2日

最終確認日

2019年8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。

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