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)
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
調査の概要
状態
条件
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
-
-
-
Panevezys、リトアニア
- 2nd Department of Internal Diseases, Panevezys Hospital,
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Vilnius、リトアニア
- Dept. Infectious Diseases and Microbiology of Vilnius University
-
-
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
説明
Inclusion Criteria:
- 18 to <61 years of age
- mentally competent to understand the nature, the scope and the consequences of the study
- able and willing to give written informed consent prior to study entry
in good health as determined by:
- medical history,
- physical examination,
- clinical judgment of the Investigator.
Exclusion Criteria:
- unwilling or unable to give written informed consent to participate in the study
- participation in another clinical trial of an investigational agent within 90 days prior to Visit 1 and throughout the entire study
- currently experiencing an acute infectious disease
any serious disease, such as, for example:
- cancer,
- autoimmune disease (including rheumatoid arthritis),
- advanced arteriosclerotic disease or complicated diabetes mellitus,
- chronic obstructive pulmonary disease (COPD) requiring oxygen therapy,
- acute or progressive hepatic disease,
- acute or progressive renal disease,
- congestive heart failure
- surgery planned during the study period
- bleeding diathesis
- history of hypersensitivity to any component of the study medication or chemically related substances
- history of any anaphylaxis, serious vaccine reactions, or allergy to any of the vaccine component
known or suspected impairment/alteration of immune function, for example resulting from:
- receipt of immunosuppressive therapy (any corticosteroid therapy or cancer chemotherapy),
- receipt of immunostimulants,
- 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,
- high risk for developing an immunocompromising disease
- history of drug or alcohol abuse
- laboratory-confirmed influenza disease within 6 months prior to Visit 1
- receipt of influenza vaccine within 6 months prior to Visit 1
- receipt of another vaccine within 60 days prior to Visit 1, or planned vaccination within 3 weeks following study vaccination
- 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
- if female, pregnant or breastfeeding
- if female, refusal to use a reliable contraceptive method during the three weeks following vaccination
- planned relocation abroad during the study period
- any condition that, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
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
- 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
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
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
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
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
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To assess the safety and tolerability in terms of number of subjects reporting solicited adverse events following one injection of
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Day 1 to Day 7 postvaccination
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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
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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
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 (実際)
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
追加の関連 MeSH 用語
その他の研究ID番号
- V58P9
- EUDRACT: 2005-002257-47
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