Non-Inferiority of Various GSK Bio's Influenza Vaccine Presentations in Adults Aged 65 Years and Over
2018年5月9日 更新者：GlaxoSmithKline
Non-Inferiority of GlaxoSmithKline Biologicals' Influenza Vaccine (GSK576389A) 1 Container Over 2 Container Presentation in Adults Aged 65 Years and Over
This observer blind study is designed to compare the immune response of GSK Biologicals' influenza vaccine GSK576389A when administered using various presentations in adults aged 65 years and older.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
調査の概要
状態
完了
条件
詳細な説明
The study contains 6 parallel groups, stratified by two age groups: 65-74 years and ≥ 75 years and by two influenza vaccination histories: no influenza vaccination in the last 3 seasons and at least one influenza vaccination in the last 3 seasons.
研究の種類
介入
入学 (実際)
1596
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。
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 aged 65 years or older at the time of the vaccination.
- Written informed consent obtained from the subject.
- Free of an acute aggravation of the health status as established by clinical evaluation before entering into the study.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to vaccination, 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 Visit 2 after vaccination.
- Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
- Vaccination against influenza since January 2007 (including the Northern Hemisphere NH 2006/2007 or NH 2007/08 influenza vaccine).
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- History of hypersensivity to a previous dose of influenza vaccine.
- History of allergy or reactions likely to be exacerbated by any component of the vaccine(s)
- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation 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 administration of the study vaccine or planned administration during the study.
- Any medical conditions in which intramuscular 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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：GSK576389A- 2006/2007 Season - 1 container Group
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
|
Single dose, intramuscular injection, GSK Bio's influenza vaccine GSK576389A formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
|
|
実験的：GSK576389A - 2006/2007 Season - 2 containers Group
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
|
Single dose, intramuscular injection, GSK Bio's influenza vaccine GSK576389A formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
|
|
アクティブコンパレータ：Fluarix 2006/2007 Season Group
Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
|
Single dose, intramuscular injection, Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
|
|
実験的：GSK576389A - 2007/2008 Season - 1 container Group
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
|
Single dose, intramuscular injection, GSK Bio's influenza vaccine GSK576389A formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
|
|
実験的：GSK576389A - 2007/2008 Season - 2 containers Group
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
|
Single dose, intramuscular injection, GSK Bio's influenza vaccine GSK576389A formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
|
|
アクティブコンパレータ：Fluarix 2007/2008 Season Group
Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
|
Single dose, intramuscular injection, Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
|
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 |
|---|---|---|
|
Haemagglutination Inhibition (HI) Antibody Titers for the H1N1 Vaccine Strain
時間枠：At Days 0 and 21
|
Antibody titers were expressed as Geometric mean titers (GMTs).
The H1N1 vaccine strains included A/New Caledonia and A/Solomon Islands antigens.
A/New Caledonia vaccine strain was administered to both groups receiving the adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season.
A/Solomon Islands vaccine strain was administered to both groups receiving the adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season.
|
At 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 |
|---|---|---|
|
要請されたローカル AE の期間
時間枠：ワクチン接種後7日間の経過観察期間中（Day 0-6）
|
期間は、局所症状の程度にかかわらず、日数として定義されました。
|
ワクチン接種後7日間の経過観察期間中（Day 0-6）
|
|
要請された一般的な AE の期間
時間枠：ワクチン接種後7日間の経過観察期間中（Day 0-6）
|
期間は、全身症状の程度にかかわらず、日数として定義されました。
|
ワクチン接種後7日間の経過観察期間中（Day 0-6）
|
|
いずれか、グレード 3 および関連する未承諾の AE を報告している被験者の数
時間枠：ワクチン接種後21日間の追跡期間中（Day 0-20）
|
要請されていない AE は、臨床研究中に要請されたものに加えて報告された AE、および要請された症状の指定されたフォローアップ期間外に発症した要請された症状をカバーします。
任意は、強度グレードまたはワクチン接種との関係に関係なく、任意の未承諾の症状の発生として定義されました。
グレード 3 は、通常の活動を妨げた事象であり、関連は、治験責任医師によって研究ワクチン接種に因果関係があると評価された未承諾の AE として定義されました。
|
ワクチン接種後21日間の追跡期間中（Day 0-20）
|
|
HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations
時間枠：At Days 0 and 21
|
Antibody titers were expressed as GMTs.
The vaccine strains included A/New Caledonia or A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
A/New Caledonia vaccine strain was administered to all groups receiving the Northern Hemisphere 2006/2007 influenza season vaccine formulations.
A/Solomon Islands vaccine strain was administered to all groups receiving the Northern Hemisphere 2007/2008 influenza season vaccine formulations.
A/Wisconsin and B/Malaysia vaccine strains were administered to all groups.
|
At Days 0 and 21
|
|
The Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations
時間枠：At 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 4-fold increase in post-vaccination titer.
The vaccine strains included A/New Caledonia (for all groups receiving vaccine formulations for the Northern Hemisphere [NH] 2006/2007 influenza season) or A/Solomon Islands (for all groups receiving vaccine formulations for the NH 2007/2008 influenza season), A/Wisconsin and B/Malaysia antigens.
|
At Day 21
|
|
HI Antibody Seroconversion Factors
時間枠：At Day 21
|
Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/New Caledonia (for all groups receiving vaccine formulations for the Northern Hemisphere [NH] 2006/2007 influenza season) or A/Solomon Islands (for all groups receiving vaccine formulations for the NH 2007/2008 influenza season), A/Wisconsin and B/Malaysia antigens.
|
At Day 21
|
|
The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations
時間枠：At Days 0 and 21
|
A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.
The vaccine strains included A/New Caledonia (for all groups receiving vaccine formulations for the Northern Hemisphere [NH] 2006/2007 influenza season) or A/Solomon Islands (for all groups receiving vaccine formulations for the NH 2007/2008 influenza season), A/Wisconsin and B/Malaysia antigens.
|
At Days 0 and 21
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
時間枠：During a 7-day follow-up period (Day 0-6) after vaccination
|
Grade 3 ecchymosis, redness and swelling was greater than 100 millimeter (mm) i.e. >100mm and grade 3 pain was considerable pain at rest that prevented normal everyday activities.
Any was occurrence of any local symptom regardless of their intensity grade.
Any for ecchymosis, redness and swelling was >20mm.
|
During a 7-day follow-up period (Day 0-6) after vaccination
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
時間枠：During a 7-day follow-up period (Day 0-6) after vaccination
|
Any temperature was defined as oral temperature greater than or equal to 38.0 degree centigrade i.e ≥38.0°C, grade 3 temperature was oral temperature ≥39.0°C.
For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a general symptom that prevented normal activity.
Related was a general symptom assessed by the investigator as causally related to the study vaccination.
|
During a 7-day follow-up period (Day 0-6) after vaccination
|
|
Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)
時間枠：During a 21-day follow-up period (Day 0-20) after vaccination
|
MSCs were defined as an AEs with a medically-attended visit (MAE) i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination.
Any MSC was defined as at least one MSC experienced.
Grade 3 was a MSC that prevented normal activities and related was defined as a MSC assessed by the investigator to be causally related to the study vaccination.
|
During a 21-day follow-up period (Day 0-20) after vaccination
|
|
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
時間枠：During a 21-day follow-up period (Day 0-20) after vaccination
|
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.
|
During a 21-day follow-up period (Day 0-20) after 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
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
2007年9月20日
一次修了 (実際)
2007年11月1日
研究の完了 (実際)
2007年11月2日
試験登録日
最初に提出
2007年9月19日
QC基準を満たした最初の提出物
2007年9月19日
最初の投稿 (見積もり)
2007年9月20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
追加の関連 MeSH 用語
その他の研究ID番号
- 110620
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
-
注釈付き症例報告書
情報識別子：110620情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
-
インフォームド コンセント フォーム
情報識別子：110620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：110620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：110620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：110620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：110620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：110620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。