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。

Non-inferiority Study of GSK Biologicals' Influenza Vaccine GSK576389A Using Different Formulations

2018年5月9日 更新者：GlaxoSmithKline

Non-inferiority Study of GlaxoSmithKline Biologicals' Influenza Vaccine GSK576389A Using Different Formulations.

The purpose of this study is to show the non-inferiority of different formulations of GlaxoSmithKline Biologicials' influenza vaccine.

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)

720

段階

  • フェーズ2

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

  • エストニア
      • Saku、エストニア、75501
        • GSK Investigational Site
      • Tallinn、エストニア、13419
        • GSK Investigational Site
      • Tartu、エストニア、50417
        • GSK Investigational Site

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

65年歳以上 (高齢者)

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:

  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
  • A male or female 65 years of age or older at the time of vaccination.
  • Written informed consent obtained from the subject.
  • Free of an acute aggravation of the health status as established by clinical evaluation (medical history and medical history directed examination) before entering into the study.

Exclusion Criteria:

  • Suspected (based on clinical symptoms) or confirmed (based on laboratory results) influenza infection within the last 6 months.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 21 days after vaccination.
  • Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
  • Previous vaccination against influenza with any seasonal vaccine since July 2007.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • History of hypersensitivity to a previous dose of influenza vaccine.
  • History of allergy or reactions likely to be exacerbated by any component of the vaccine(s) including egg and chicken protein.
  • Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation (medical history and medical history directed physical examination) or pre-existing laboratory screening tests.
  • Acute disease at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
  • Any medical conditions in which IM injections are contraindicated

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：Thiomersal-free FluAS25 adjuvanted vaccine group
Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
生物学的：Thiomersal-free FluAS25 adjuvanted vaccine (GSK576389A)
Intramuscular administration, 1 dose
実験的：Thiomersal reduced FluAS25 adjuvanted vaccine group
Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
生物学的：Thiomersal reduced FluAS25 adjuvanted vaccine (GSK576389A)
Intramuscular administration, 1 dose

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
Serum Haemagglutination-inhibition (HI) Antibody Titer Against the Three Vaccine Strains
時間枠：Days 0 and 21
Titers were expressed as Geometric Mean Titers (GMTs). The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
Days 0 and 21

二次結果の測定

結果測定
メジャーの説明
時間枠
Number of Subjects Seropositive for HI Antibodies Against the Three Vaccine Strains
時間枠：Days 0 and 21
A seropositive subject was defined as a subject with a serum HI titer greater than or equal to 1:10. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
Days 0 and 21
Number of Subjects Seroconverted for HI Antibodies Against the Three Vaccine Strains
時間枠：Day 21
A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a four-fold increase in post-vaccination titer. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
Day 21
HI Antibody Seroconversion Factors
時間枠：Day 21
Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
Day 21
Number of Subjects Seroprotected for HI Antibodies Against the Three Vaccine Strains
時間枠：Days 0 and 21
A seroprotected subject was defined as a suject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.
Days 0 and 21
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
時間枠：During a 7-day period after vaccination
Solicited local symptoms assessed include ecchymosis, pain, redness and swelling. Any: any symptom regardless of intensity grade. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter.
During a 7-day period after vaccination
Duration of Solicited Local Symptoms
時間枠：During a 7-day period after vaccination
Duration was expressed as median number of days the symptom persisted. Solicited local symptoms assessed include ecchymosis, pain, redness and swelling.
During a 7-day period after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
時間枠：During a 7-day period after vaccination
Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: any symptom regardless of intensity grade; any fever: oral temperature greater than or equal to 38 degrees Celsius (°C). Grade 3: symptoms that prevented normal activity ; Grade 3 fever: oral temperature greater than 39°C. Related: symptom assessed by the investigator as causally related to the study vaccination.
During a 7-day period after vaccination
Duration of Solicited General Symptoms
時間枠：During a 7-day period after vaccination
Duration was expressed as median number of days the symptom persisted. Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever.
During a 7-day period after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
時間枠：During a 21-day period after vaccination
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
During a 21-day period after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)
時間枠：During a 21-day period after vaccination
Medically Significant Conditions (MSCs) included all unsolicited adverse events that resulted in a medically attended visit.
During a 21-day period after vaccination
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
時間枠：During the entire study period (up to Day 21)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
During the entire study period (up to Day 21)

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

GlaxoSmithKline

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。

便利なリンク

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

2008年3月3日

一次修了 (実際)

2008年4月11日

研究の完了 (実際)

2008年4月11日

試験登録日

最初に提出

2008年2月29日

QC基準を満たした最初の提出物

2008年3月10日

最初の投稿 (見積もり)

2008年3月11日

学習記録の更新

投稿された最後の更新 (実際)

2018年6月8日

QC基準を満たした最後の更新が送信されました

2018年5月9日

最終確認日

2016年11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

  • 111454

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

試験データ・資料

  1. 統計分析計画
    情報識別子：111454
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  2. 個人参加者データセット
    情報識別子：111454
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  3. インフォームド コンセント フォーム
    情報識別子：111454
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  4. データセット仕様
    情報識別子：111454
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  5. 臨床研究報告書
    情報識別子：111454
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  6. 研究プロトコル
    情報識別子：111454
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  7. 注釈付き症例報告書
    情報識別子：111454
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register

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。

購読する