Immunogenicity and Safety Study of a GSK Influenza Vaccine Candidate in Adults.
2018年5月9日 更新者：GlaxoSmithKline
Immunogenicity and Safety Study of a GSK Influenza Vaccine Candidate GSK 2115160A in Adults.
The purpose of this study is to evaluate the safety and immunogenicity of GSK influenza vaccine candidate compared to a licensed trivalent influenza vaccine in adults.
調査の概要
状態
完了
条件
研究の種類
介入
入学 (実際)
420
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
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Hradec Kralove、チェコ、500 03
- GSK Investigational Site
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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
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female between, and including, 18 and 60 years of age at the time of the vaccination.
- Written informed consent obtained from the subject.
- If the subject is female, she must be of non-childbearing potential, if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 3 months prior to administration of the vaccine.
- Administration of a vaccine not foreseen in the study protocol from 30 days before vaccination up to 21 days post vaccination.
- Confirmed influenza infection within a year preceding the study start.
- Administration of an influenza vaccine during Northern Hemisphere season 2007-2008.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- History of hypersensitivity to a previous dose of influenza vaccine
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
- Acute disease at the time of enrolment.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Administration of immunoglobulins and/or any blood products within the three months preceding the administration of study vaccine or planned administration during the study period.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
- History of chronic alcohol consumption and/or drug abuse.
- Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
- History of administration of experimental/licensed vaccine.
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 |
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実験的：Quadrivalent influenza vaccine GSK 2115160A Group 1
Subjects in this group received 1 full dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
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Single intramuscular dose on Day 0.
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実験的：Quadrivalent influenza vaccine GSK 2115160A Group 2
Subjects in this group received 1 low dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
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Single intramuscular dose on Day 0.
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アクティブコンパレータ：Trivalent influenza vaccine GSK 2115160A Group 1
Subjects in this group received 1 low dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
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Single intramuscular dose on Day 0.
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アクティブコンパレータ：Trivalent influenza vaccine GSK 2115160A Group 2
Subjects in this group received 1 full dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
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Single intramuscular dose on Day 0.
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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 |
|---|---|---|
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Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains.
時間枠：At Day 0 and Day 21
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Antibody titers were expressed as Geometric mean titers (GMTs).The vaccine influenza strains included A/Solomon Islands,A/Wisconsin,B/Malaysia and B/Jiangsu antigens.
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At Day 0 and Day 21
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of Subjects Seroconverted for HI Antibodies Against the Vaccine Influenza Strains.
時間枠：At Day 21
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A seroconverted subject was defined as a subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.
The vaccine influenza strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens.
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At Day 21
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HI Antibody Seroconversion Factors Against the Vaccine Influenza Strains
時間枠：Day 21
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Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The Influenza vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens.
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Day 21
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Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains.
時間枠：At Days 0 and 21
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A seroprotected subject was defined as a subject with a serum HI titer ≥1:40 that usually is accepted as indicating protection.
The Influenza vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens.
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At Days 0 and 21
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Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
時間枠：During a 7 day (Days 0-6) follow-up period after vaccination
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Solicited local symptoms assessed were pain, redness and swelling.
Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade.
Grade 3 pain was defined as considerable pain that prevented normal activity.
Grade 3 redness and swelling were defined as redness/swelling above 100 millimeters (mm).
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During a 7 day (Days 0-6) follow-up period after vaccination
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Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading.
時間枠：During a 7-day follow-up period (Days 0-6) after vaccination
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Solicited local symptoms assessed by the former GSK rules of grading were pain, redness and swelling.
Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade.
Grade 3 pain was defined as pain that prevented normal activity.
Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm).
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During a 7-day follow-up period (Days 0-6) after vaccination
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Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
時間枠：During a 7-day follow-up period (Days 0-6) after vaccination
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Solicited general symptoms assessed were arthralgia, fatigue, headache, myalgia, nausea, shivering and fever.
Any =occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination.
Any fever = oral temperature ≥ 38.0 degrees Celsius (°C).. Grade 3 symptoms = symptoms that prevented normal activities.
Grade 3 fever = oral temperature ≥39.0°C.
Related = symptoms considered by the investigator to have a causal relationship to vaccination
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During a 7-day follow-up period (Days 0-6) after vaccination
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Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading.
時間枠：During a 7-day follow-up period (Days 0-6) after vaccination
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Solicited general symptoms assessed by the former GSK rules of grading were arthralgia, fatigue, headache, myalgia, nausea, shivering and fever.
Any = occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination.
Any fever = oral temperature ≥ 37.5 °C.
Grade 3 symptoms = symptoms that prevented normal activities.
Grade 3 fever = oral temperature above 39.0°C. .
Related = symptoms considered by the investigator to have a causal relationship to vaccination.
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During a 7-day follow-up period (Days 0-6) after vaccination
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Number of Subjects Reporting Any Medically Significant Conditions (MSCs) and Auto-immune Diseases (AIDs).
時間枠：During the entire study period (Days 0-180)
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MSCs were defined as those adverse events (AEs) prompting emergency room visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination.
AIDs include a large group of diseases characterized by abnormal functioning of the immune system that causes immune system to produce antibodies against own tissues.
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During the entire study period (Days 0-180)
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Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AE(s).
時間枠：During a 21 day (Days 0-20) follow-up period after vaccination-
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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.
Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination
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During a 21 day (Days 0-20) follow-up period after vaccination-
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Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
時間枠：During the entire study period (Days 0-180)
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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.
Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
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During the entire study period (Days 0-180)
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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
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
2008年7月14日
一次修了 (実際)
2009年1月28日
研究の完了 (実際)
2009年1月28日
試験登録日
最初に提出
2008年7月11日
QC基準を満たした最初の提出物
2008年7月11日
最初の投稿 (見積もり)
2008年7月14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
2017年3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
- 111295
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
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インフォームド コンセント フォーム
情報識別子：111295情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
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臨床研究報告書
情報識別子：111295情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
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注釈付き症例報告書
情報識別子：111295情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
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研究プロトコル
情報識別子：111295情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
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個人参加者データセット
情報識別子：111295情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
-
データセット仕様
情報識別子：111295情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
-
統計分析計画
情報識別子：111295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。