Study to Evaluate the Immunogenicity and the Safety of an Adjuvanted Influenza Vaccine Candidate
2018年5月9日 更新者：GlaxoSmithKline
A Study to Evaluate the Immunogenicity, Safety and Reactogenicity of Adjuvanted Influenza Vaccine Candidate Compared to Fluarix™ (GlaxoSmithKline Biologicals) Administered Intramuscularly in Elderly Aged 60 Years and Older.
The purpose of this study is to evaluate the immunogenicity and the safety of the candidate vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years and above
調査の概要
研究の種類
介入
入学 (実際)
150
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
-
-
-
Gent、ベルギー、9000
- 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
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:
- Subjects who the investigator believes that they can and wil comply with the requirements of the protocol should be enrolled in the study.
- A male or female 60 years or older at the time of the first vaccination.
- Free of obvious health problems
Exclusion Criteria:
- Use of non-registered products
- Administration of immune-modifying drugs.
- Administration of vaccine 30 days before enrolment in study.
- Immunosuppressive or immunodeficient condition.
- Hypersensitivity to a previous dose of influenza vaccine
- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality.
- History of confirmed influenza infection within the last 12 Months.
- Acute disease at the time of enrolment/vaccination.
- History of allergy or reactions likely to be exacerbated by any component of the 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 |
|---|---|
|
実験的：GSK1247446A Group
Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03.
The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Low dose influenza vaccine adjuvanted with AS03 compared
他の名前：
|
|
アクティブコンパレータ：Fluarix Group
Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine.
The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
GlaxoSmithKline (GSK) Biologicals' inactivated influenza split vaccine.
|
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 |
|---|---|---|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
時間枠：At Days 0 and 21
|
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.
|
At Days 0 and 21
|
|
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.
時間枠：At Day 21
|
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.
|
At Day 21
|
|
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
時間枠：At Day 0 and Day 21
|
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.
|
At Day 0 and Day 21
|
|
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
時間枠：At Day 21
|
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.
|
At Day 21
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
時間枠：At Days 0 and 21
|
The geometric mean was calculated for CD4 T-cells (per million CD4 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-g), at least IL2 and at least TNF alpha (TNF-α).
|
At Days 0 and 21
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
時間枠：At Days 0 and 21
|
The geometric mean was calculated for CD8 T-cells (per million CD8 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-g), at least IL2 and at least TNF alpha (TNF-α).
|
At Days 0 and 21
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.
時間枠：During the 7-day (Days 0-6) post-vaccination period
|
Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site.
Any = incidence of a particular symptom regardless of intensity grade.
Grade 3 pain = pain that prevented normal activity.
Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site.
All solicited local symptoms were considered to be related to vaccination.
|
During the 7-day (Days 0-6) post-vaccination period
|
|
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
|
Assessed solicited general symptoms were arthralgia, fatigue, fever [axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, muscle aches and shivering.
Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination.
Grade 3 symptom = symptom that prevented normal activity.
Grade 3 fever = fever > 39.0°C.
Related = symptom considered by the investigator to have a causal relationship to study vaccination.
|
During the 7-day (Days 0-6) post-vaccination period
|
|
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
|
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 everyday activities.
Related = unsolicited AE assessed by the investigator as related to the vaccination.
|
During the 30-day (Days 0-29) post vaccination period
|
|
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)
|
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.
Related = SAE considered by the investigator to have a causal relationship to study vaccination.
|
During the entire study period (from Day 0 to Day 29)
|
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2日
一次修了 (実際)
2006年11月1日
研究の完了 (実際)
2006年11月17日
試験登録日
最初に提出
2006年8月7日
QC基準を満たした最初の提出物
2006年8月11日
最初の投稿 (見積もり)
2006年8月15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
- 107975
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
-
インフォームド コンセント フォーム
情報識別子：107975情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
-
個人参加者データセット
情報識別子：107975情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
-
研究プロトコル
情報識別子：107975情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
-
臨床研究報告書
情報識別子：107975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：107975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。
GSK1247446A Groupの臨床試験
-
University Hospital, GhentUniversity Ghent募集
-
GlaxoSmithKline完了
-
Centre hospitalier de l'Université de Montréal...University Health Network, Toronto; University of British Columbia; McGill University; University... と他の協力者募集
-
University of HawaiiNational Institute on Minority Health and Health Disparities (NIMHD)完了