Study to Evaluate the Immunogenicity and Safety of a Second Vaccination With the Adjuvanted Influenza Vaccine Candidate
2018年5月9日 更新者：GlaxoSmithKline
A Study to Evaluate the Immunogenicity, Safety and Reactogenicity of a Second Vaccination With the Adjuvanted Influenza Vaccine Candidate Compared to Fluarix™ Administered Intramuscularly in Elderly Aged 60 Years and Above.
The purpose of this study is to evaluate the immunogenicity and the safety of a second vaccination with candidate vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years and above
調査の概要
詳細な説明
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
研究の種類
介入
入学 (実際)
678
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
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Elverum、ノルウェー、2408
- GSK Investigational Site
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Hamar、ノルウェー、2301
- GSK Investigational Site
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Paradis、ノルウェー、5231
- GSK Investigational Site
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Stavanger、ノルウェー、4010
- 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
60年歳以上 (大人、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:
- A male or female age 60 years or older at the time of the revaccination, who previously participated in 107192 & 107214 clinical trials.
- Subjects who the investigator believes can and will comply with the requirements of the protocol
- Written informed consent obtained from the subject.
- Free of an acute aggravation of the health status as established by clinical examination before entering into the study.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 3 months prior to the first vaccine dose.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration 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 30 days after vaccination.
- History of hypersensitivity to a previous dose of influenza vaccine.
- History of confirmed influenza infection within the last 12 months.
- History of allergy or reactions likely to be exacerbated by any component of the vaccine(s)
- Acute disease at the time of enrolment.
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：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ：Fluarix Group
Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study.
The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
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Single dose, intramuscular injection
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実験的：GSK1247446A Group
Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study.
The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
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Single dose, intramuscular injection
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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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Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
時間枠：During the 7-day (Days 0-6) post-vaccination period
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Assessed solicited local symptoms were ecchymosis, pain, redness and swelling.
Any = Incidence of a particular solicited local symptom regardless of intensity grade.
Grade 3 pain = Pain that prevented normal everyday activity.
Grade 3 redness/swelling/ecchymosis = Redness/swelling/ecchymosis above 50 millimeters (mm).
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During the 7-day (Days 0-6) post-vaccination period
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Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
時間枠：During the 7-day (Days 0-6) post-vaccination period
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Assessed solicited general symptoms were arthralgia, fatigue, fever, headache, muscle aches and shivering.
Any = Incidence of a particular solicited general symptom regardless of intensity grade or relationship with the study vaccination.
Any Fever = Axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C).
Grade 3 symptom = Symptom that prevented normal activity.
Grade 3 fever = Axillary temperature > 39.0°C.
Related = Symptom considered by the investigator to have a causal relationship to study vaccination.
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During the 7-day (Days 0-6) post-vaccination period
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Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
時間枠：During the 30-day (Days 0-29) post vaccination period
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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 = Any unsolicited AE regardless of intensity or relationship to vaccination.
Grade 3 = Unsolicited AE that prevented normal activity.
Related = Unsolicited AE assessed by the investigator as causally related to the vaccination.
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During the 30-day (Days 0-29) post vaccination period
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Number of Subjects With Any and Related Serious Adverse Events (SAEs).
時間枠：During the entire study period (from Day 0 to Day 29)
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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 SAE = Occurrence of any SAE regardless of intensity grade or relation to vaccination Related = SAE considered by the investigator to have a causal relationship to study vaccination.
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During the entire study period (from Day 0 to Day 29)
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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 Seroconverted Subjects Against 3 Strains of Influenza Disease.
時間枠：At Day 21
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A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer.
The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
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At Day 21
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Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
時間枠：At Day 0 and Day 21
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A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40.
The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
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At Day 0 and Day 21
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Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
時間枠：At Day 21
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The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
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At Day 21
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Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
時間枠：At Day 0 and Day 21
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Titers are presented as geometric mean titers (GMTs).
The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
The seropositivity cut-off assay was 1:10.
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At Day 0 and Day 21
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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
2006年10月20日
一次修了 (実際)
2007年2月1日
研究の完了 (実際)
2007年2月5日
試験登録日
最初に提出
2006年10月10日
QC基準を満たした最初の提出物
2006年10月10日
最初の投稿 (見積もり)
2006年10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
- 108708
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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個人参加者データセット
情報識別子：108708情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
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統計分析計画
情報識別子：108708情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
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データセット仕様
情報識別子：108708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：108708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：108708情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
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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：108708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。
FluarixTMの臨床試験
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