このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

Pediatric Safety and Immunogenicity Study of Cell-Culture Derived and Egg-based Subunit Influenza Vaccines in Healthy Children and Adolescents

2015年10月20日 更新者：Novartis

A Combined Phase II/III, Observer-Blind, Randomized, Multi-center Study to Evaluate Safety, Tolerability and Immunogenicity of Trivalent Subunit Influenza Vaccines, Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs, in Healthy Children and Adolescents

The present study is the first study designed to evaluate safety, tolerability and immunogenicity of the cell culture-derived influenza vaccine in healthy children and adolescents aged 3 to 17 years. A step-down approach is utilized in which reactogenicity and safety will be assessed in children and adolescents 9 to 17 years of age (Cohort 1) prior to enrolling additional children and adolescents 9 to 17 years of age (Cohort 2) and children 3 to 8 years of age (Cohort 3).

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

3604

段階

  • フェーズ2
  • 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

  • アメリカ
    • Arkansas
      • Fayetteville、Arkansas、アメリカ、72703
        • Site 09
    • California
      • Downey、California、アメリカ、90241
        • Site 10
    • Kentucky
      • Bardstown、Kentucky、アメリカ、40004
        • Site 02
    • Louisiana
      • Metairie、Louisiana、アメリカ、70006
        • Site 14
    • Missouri
      • St. Louis、Missouri、アメリカ、63104
        • Site 01
    • Nebraska
      • Omaha、Nebraska、アメリカ、68134
        • Site 11
    • New Jersey
      • Edison、New Jersey、アメリカ、08817
        • Site 04
    • New York
      • Endwell、New York、アメリカ、13760
        • Site 05
    • Texas
      • Fort Worth、Texas、アメリカ、76135
        • Site 16
      • San Angelo、Texas、アメリカ、76904
        • Site 13
      • San Antonio、Texas、アメリカ、78205
        • Site 12
    • Utah
      • Bountiful、Utah、アメリカ、84010
        • Site 08
      • Salt Lake City、Utah、アメリカ、84109
        • Site 07
      • Salt Lake City、Utah、アメリカ、84121
        • Site 03
    • Virginia
      • Burke、Virginia、アメリカ、22105
        • Site 06
    • Washington
      • Spokane、Washington、アメリカ、99202
        • Site 15
  • イタリア
      • Ferrara、イタリア、44100
        • Site 42: Dipartimento di Medicina Clinica e Sperimentale - Sezione di Igiene e Medicina Preventiva
      • Genova、イタリア、16132
        • Site 47: Dipartimento Scienze della Salute, Sezione di Igiene e Medicina Preventiva, Univesità di Genova
      • Novara、イタリア、28100
        • Site 41: Ospedale Maggiore della Carità-Clinica Pediatrica
      • Perugia、イタリア、06070
        • Site 46: USL 2 Perugia, Distretto del perugino, Centro di Salute n. 4 (Madonna Alta) e n. 6 (Ellera di Corciano del distretto del perugino)
      • Ragusa、イタリア、97100
        • Site 45: AUSL 7
  • クロアチア
      • Dakovo、クロアチア
        • Site 44:Spec. Pediatric Dispensary
      • Ljudevita Gaja 2, Djakovo、クロアチア
        • Site 83
      • Sisak、クロアチア
        • Site 43: Spec. Pediatric Dispensary
      • Zagreb、クロアチア
        • Site 27:Institute of Public Health
      • Zagreb、クロアチア
        • Site 29: Institute of Public Health
      • Zagreb、クロアチア
        • Site 40:Spec. Pediatric Dispensary
      • Zagreb、クロアチア
        • Site 49: Spec. Pediatric Dispensary
      • Zagreb、クロアチア
        • Site 50: Spec. Pediatric Dispensary
      • Zagreb、クロアチア
        • Site 86: Spec. Pediatric Dispensary
  • ハンガリー
      • Budapest、ハンガリー、1042
        • Site 57: Házi Gyermekorvosi Rendelő
      • Budapest、ハンガリー、1089
        • Site 53: Heim Pál Gyermekkórház
      • Budapest、ハンガリー、1097
        • Site 52: Ferencvárosi Gyermekorvos Kft.
      • Budapest、ハンガリー、1136
        • Site 56: Házi Gyermekorvosi Rendelő
      • Budapest、ハンガリー、1173
        • Site 54: Házi Gyermekorvosi Rendelő
      • Miskolc、ハンガリー、3534
        • Site 51: 5053. számú Gyermekorvosi Rendelő
      • Nyíregyháza、ハンガリー、4481
        • Site 55: Revamed kft.
      • Szombathely、ハンガリー、9700
        • Site 59: Vas Megyei Markusovszky Lajos, Általános, Rehabilitációs és Gyógyfürdő Kórház, Egyetemi Oktató Kórház
  • フィンランド
      • Helsinki、フィンランド、00100
        • Site 71: Etelä-Helsingin rokotetutkimusklinikka
      • Helsinki、フィンランド、00930
        • Site 72: Itä-Helsingin rokotetutkimusklinikka
      • Järvenpää、フィンランド、04400
        • Site 76: Järvenpään rokotetutkimusklinikka
      • Kotka、フィンランド、48600
        • Site 77: Kotkan rokotetutkimusklinikka
      • Lahti、フィンランド、15140
        • Site 67: Lahden rokotetutkimusklinikka
      • Oulu、フィンランド、90100
        • Site 75: Oulun rokotetutkimusklinikka
      • Pori、フィンランド、28120
        • Site 68: Porin rokotetutkimusklinikka
      • Tampere、フィンランド、33100
        • Site 66: Tampereen rokotetutkimusklinikka
      • Turku、フィンランド、20520
        • Site 69: Turun rokotetutkimusklinikka
      • Vantaa、フィンランド、01300
        • Site 73: Itä-Vantaan rokotetutkimusklinikka
      • Vantaa、フィンランド、01600
        • Site 74: Länsi-Vantaan rokotetutkimusklinikka
    • Espoo
      • Heikintori、Espoo、フィンランド、02100
        • Site 70: Espoon rokotetutkimusklinikka
    • Kokkola
      • Rantakatu 7、Kokkola、フィンランド、67100
        • Site 79: Kokkola Vaccine Research Clinic
    • Kuopio
      • Microkatu 1,Osa/Section A, 3rd floor PL1188、Kuopio、フィンランド、70211
        • Site 78: Kuopio Vaccine Research Clinic
  • リトアニア
      • Kaunas、リトアニア、48259
        • Site 35
      • Vilnius、リトアニア、01117
        • Site 36
      • Vilnius、リトアニア、02169
        • Site 32
      • Vilnius、リトアニア、04318
        • Site 34
      • Vilnius、リトアニア、10207
        • Site 31
      • Vilnius、リトアニア、11200
        • Site 33
  • ルーマニア
    • Arges
      • Campulung Muscel、Arges、ルーマニア、115100
        • Site 25
    • Dolj
      • Craiova、Dolj、ルーマニア、200642
        • Site 21

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～17年 (子)

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:

  1. Subjects aged 9 to 17 years (Cohorts 1 and 2) and 3 to 8 years (Cohort 3), whose parents/legal guardians have given written informed consent prior to study entry. Assent will be obtained from subjects according to age requirements of the ECs/IRBs;

  2. In good health as determined by:

    1. medical history,
    2. physical examination,
    3. clinical judgment of the Investigator;
  3. Able to comply with all study procedures and available for all clinic visits and telephone calls scheduled in the study.

Exclusion Criteria:

  1. Any serious disease, such as:

    1. cancer,
    2. autoimmune disease (including rheumatoid arthritis),
    3. diabetes mellitus,
    4. chronic pulmonary disease,
    5. acute or progressive hepatic disease,
    6. acute or progressive renal disease;
  2. History of any anaphylaxis or serious reaction following administration of vaccine, or hypersensitivity to eggs, egg protein, chicken feathers, influenza viral protein, neomycin, polymyxin, or any other vaccine component, chemically related substance, or component of the potential packaging materials;

  3. Known or suspected impairment/alteration of immune function, including:

    1. use of immunosuppressive therapy such as systemic corticosteroids known to be associated with the suppression of hypothalamic-pituitary-adrenal (HPA) axis or chronic use of inhaled high-potency corticosteroids within 60 days prior to Visit 1,
    2. cancer chemotherapy,
    3. receipt of immunostimulants within 60 days prior to Visit 1,
    4. receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months prior to Visit 1 or planned during the full length of the study,
    5. known HIV infection or HIV-related disease;
  4. History of Guillain-Barré syndrome;
  5. Bleeding diathesis;
  6. Surgery planned during the study period;
  7. Receipt of another investigational agent within 90 days, or before completion of the safety follow-up period in another study, whichever is longer, prior to enrollment and unwilling to refuse participation in another clinical study through the end of the study;
  8. Receipt of another vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to Visit 1;
  9. Laboratory-confirmed influenza disease within 6 months prior to Visit 1;
  10. For subjects aged 3 to 8 years old, ever received two doses of an influenza vaccine in one influenza season;
  11. Receipt of an influenza vaccine within 6 months prior to Visit 1;
  12. Experienced a temperature 38.0°C [100.4°F]) and/or any acute illness within 3 days prior to Visit 1;
  13. Pregnant or nursing mother;
  14. Female of childbearing potential who is sexually active and has not used acceptable birth control measures for at least 2 months prior to study entry and who does not plan to use acceptable birth control measures during the 3 weeks following vaccination or refuses to have a urine pregnancy test prior to enrollment. Oral, injected, inserted or implanted hormonal contraceptive, diaphragm or condom with spermicidal agent or intrauterine device are considered acceptable forms of birth control;
  15. Children of research staff or those living with research staff directly involved with the clinical study. Research staff are individuals with direct study subject contact, indirect contact with study subjects, or study site personnel who have access to any study documents containing subject information. This would include receptionists, persons scheduling appointments or making screening calls, regulatory specialists, laboratory technicians, etc.;
  16. Any condition, which 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：Cohorts 1 + Cohort 2 (9-17 Yrs) cTIV
All subjects received one 0.5 mL IM injection, of cell culture-derived trivalent influenza vaccine containing 15μg of HA for each strain (A/Solomon Islands/3/2006 [H1N1]-like, A/Wisconsin/67/2005 [H3N2]-like, and B/Malaysia/ 2506/2004-like), recommended for the 2007-2008 influenza season in the Northern Hemisphere
生物学的：Cell culture-derived influenza subunit vaccine (cTIV)
One 0.5 ml injection of the cell culture-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm.
生物学的：Cell culture-derived influenza subunit vaccine (cTIV)
Two 0.5 mL injections,of the cell culture-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm, administered four weeks apart.
アクティブコンパレータ：Cohorts 1 + Cohort 2 (9-17 Yrs) eTIV
All subjects received one 0.5 mL injection, of egg -derived trivalent influenza vaccine containing 15μg of HA for each strain (A/Solomon Islands/3/2006 [H1N1]-like, A/Wisconsin/67/2005 [H3N2]-like and B/Malaysia/ 2506/2004-like), recommended for the 2007-2008 influenza season in the Northern Hemisphere.
生物学的：Egg derived influenza subunit vaccine (eTIV)
One 0.5 ml injection of the conventional egg-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm.
生物学的：Egg derived influenza subunit vaccine (eTIV)
Two 0.5 mL injections of the conventional egg-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm,administered four weeks apart.
実験的：Cohort 3 (3-8 Yrs) cTIV
All subjects received two 0.5 mL injections, administered four weeks apart, of cell culture-derived trivalent influenza vaccine containing 15μg of HA for each strain (A/Solomon Islands/3/2006 [H1N1]-like, A/Wisconsin/67/2005 [H3N2]-like and B/Malaysia/ 2506/2004-like), recommended for the 2007-2008 influenza season in the Northern Hemisphere
生物学的：Cell culture-derived influenza subunit vaccine (cTIV)
One 0.5 ml injection of the cell culture-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm.
生物学的：Cell culture-derived influenza subunit vaccine (cTIV)
Two 0.5 mL injections,of the cell culture-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm, administered four weeks apart.
アクティブコンパレータ：Cohort 3 (3-8 Yrs) eTIV
All subjects received two 0.5 mL injections, administered four weeks apart of egg -derived trivalent influenza vaccine containing 15μg of HA for each strain (A/Solomon Islands/3/2006 [H1N1]-like, A/Wisconsin/67/2005 [H3N2]-like and B/Malaysia/ 2506/2004-like), recommended for the 2007-2008 influenza season in the Northern Hemisphere
生物学的：Egg derived influenza subunit vaccine (eTIV)
One 0.5 ml injection of the conventional egg-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm.
生物学的：Egg derived influenza subunit vaccine (eTIV)
Two 0.5 mL injections of the conventional egg-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm,administered four weeks apart.

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 of the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children
時間枠：Day 50 post vaccination

To demonstrate non-inferiority of the post vaccination hemagglutination inhibition (HI) geometric mean titer (GMT) of the cell culture-derived influenza (cTIV) vaccine to the corresponding GMT of the egg-derived (eTIV) influenza vaccine, for all three strains, after two injections administered four weeks apart to a subset of children 3 to 8 years of age.

GMTs were evaluated using two assays, HI egg derived antigen assay and HI cell derived antigen assay.
Day 50 post vaccination
Percentages of Subjects Who Attained Seroconversion or Significant Increase in Antibody Titers in the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children
時間枠：Day 50 post vaccination

To demonstrate non-inferiority of the cell culture-derived influenza (cTIV) vaccine to the egg-derived (eTIV) influenza vaccine in the percentage of subjects achieving seroconversion or significant increase in antibody titer post vaccination, for all three strains, after two injections administered four weeks apart in children 3 to 8 years of age.

Seroconversion rate was evaluated using two assays- HI egg derived antigen assay and HI cell derived antigen assay.
Day 50 post vaccination

二次結果の測定

結果測定
メジャーの説明
時間枠
Geometric Mean Titers After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents
時間枠：Day 29 post vaccination

To evaluate immunogenicity in terms of Geometric Mean Titers (GMTs) in children 9 to 17 years of age after one injection of either cTIV vaccine or eTIV.

GMTs were evaluated using two assays, HI egg derived antigen assay and HI cell derived antigen assay.
Day 29 post vaccination
Geometric Mean Ratio After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents.
時間枠：Day 29 post vaccination

Immunogenicity was evaluated in terms of Geometric Mean Ratio (GMRs) in 9 to 17 year-old children and adolescents after one injection of either cTIV vaccine or eTIV.

The criterion is met according to European (CHMP) guideline if the mean geometric increase GMR (day29/day1) in HI antibody titer is >2.5.
Day 29 post vaccination
Percentages of Subjects Who Achieved HI Titers ≥40 After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents
時間枠：Day 29 post vaccination

To evaluate immunogenicity in terms of percentage of 9 to 17 year-old children and adolescents achieving HI titers ≥40, after one injection of either the cTIV vaccine or the eTIV vaccine.

This criterion is met according to European (CHMP) guideline if the percentage of subjects achieving HI titers ≥40 is >70% and according to the US (CBER) guideline is met if the lower bound of the two sided 95%CI for percentage of subjects achieving HI titers ≥40 is ≥70%.
Day 29 post vaccination
Percentages of Subjects Who Attained Seroconversion or Significant Increase After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents
時間枠：Day 29 post vaccination

Seroconversion or significant increase as per CHMP criteria is defined as percentage of subjects with a pre vaccination HI titer <10 to a post vaccination titer ≥40 or a pre vaccination HI titer ≥10 and a ≥4-fold increase in post vaccination HI antibody titer. According to the CHMP criteria, the percentage of subjects achieving seroconversion or significant increase should be >40%.

According to the CBER criteria, the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion/significant increase should be ≥40%.
Day 29 post vaccination
Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children
時間枠：Day 29 and Day 50 post vaccination
To evaluate immunogenicity in terms of Geometric Mean Titers (GMTs) in children 3 to 8 years of age after two doses of either cTIV vaccine or eTIV,administered 4 weeks apart.
Day 29 and Day 50 post vaccination
Geometric Mean Ratio After Two Doses of the Cell-derived or the Egg-derived Vaccine in 3 to 8 Year-old Children
時間枠：Day 29 and Day 50 post vaccination

To evaluate immunogenicity in terms of Geometric Mean Ratio (GMR) in children 3 to 8 years of age after two doses of either the cTIV vaccine or the eTIV vaccine, administered 4 weeks apart according to the CHMP criteria.

The criterion is met according to the European (CHMP) guideline if the mean geometric increase (GMR day 29/day 1 and GMR day 50/day 1) in HI antibody titer is >2.5
Day 29 and Day 50 post vaccination
Percentages of Subjects Who Achieved HI Titers ≥40 After Two Doses of the Cell Culture Derived or the Egg Derived Influenza Vaccine in 3 to 8 Year-old Children
時間枠：Day 29 and Day 50 post vaccination

To evaluate immunogenicity in terms of HI titers ≥40, in children 3-8 years of age after two doses of either cTIV vaccine or eTIV vaccine, administered 4 weeks apart.

The criterion is met according to European (CHMP) guideline if the percentage of subjects achieving HI titers ≥40 is >70% and according to the US (CBER) guideline if the lower bound of the two sided 95%CI for percentage of subjects achieving HI titers ≥40 is ≥70%.
Day 29 and Day 50 post vaccination
Percentages of Subjects Who Achieved Seroconversion or Significant Increase in HI Titers After Two Doses of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 3 to 8 Year-old Children
時間枠：Day 29 and Day 50 post vaccination

Seroconversion or significant increase as per CHMP criteria is defined as percentage of subjects with a pre vaccination HI titer <10 to a post vaccination titer ≥40 or a pre vaccination HI titer ≥10 and a ≥4-fold increase in post vaccination HI antibody titer. According to the CHMP criteria, the percentage of subjects achieving seroconversion or significant increase should be >40%.

According to the CBER criteria, the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion/significant increase should be ≥40%.
Day 29 and Day 50 post vaccination
Number of Subjects Reporting Local and Systemic Reactions After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents.
時間枠：up to 7 days after vaccination
To evaluate safety and tolerability in terms of number of 9 to 17 year-old children and adolescents (cohorts 1 and 2) reporting local and systemic reactions following of one injection of the cTIV or the eTIV vaccine .
up to 7 days after vaccination
Number of Subjects Reporting Local and Systemic Reactions After One and Two Doses of the Cell Culture-derived Vaccine or Egg-derived Influenza Vaccine in 3 to 8 Year-old Children.
時間枠：up to 7 days after each vaccination
To evaluate the safety and tolerability of the cTIV and the eTIV influenza vaccines in 3 to 8 year-old children terms of number of participants reporting local and systemic reactions after each vaccination.
up to 7 days after each 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

Novartis

協力者

Novartis Vaccines

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。

一般刊行物

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10月1日

一次修了 (実際)

2008年2月1日

研究の完了 (実際)

2008年7月1日

試験登録日

最初に提出

2008年3月21日

QC基準を満たした最初の提出物

2008年3月21日

最初の投稿 (見積もり)

2008年3月27日

学習記録の更新

投稿された最後の更新 (見積もり)

2015年11月23日

QC基準を満たした最後の更新が送信されました

2015年10月20日

最終確認日

2015年10月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • V58P12
  • Eudract Number: 2007-001534-13

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。

類似の治験を検索

スポンサーと協力者

医学的状態

薬物療法

CROs by country

CROs in Netherlands

条件

まれな病気

薬物療法

ダイエットサプリメント

スポンサー/協力者

場所

3
購読する