Study to Evaluate the Safety and Immunogenicity of a Pandemic Influenza Vaccine in Adults Aged 18 Years and Above
2018年5月28日 更新者：GlaxoSmithKline
A Phase III, Observer-blind, Randomised Study to Evaluate the Safety and Immunogenicity of One and Two Administrations of Pandemic Monovalent (H5N1) Influenza Vaccine (Adjuvanted Split Virus Formulation) in Adults Aged 18 Years and Older
Today, the leading contender for the next pandemic of influenza is H5N1, a strain of avian virus.
Prevention and control will depend on the rapid production and worldwide distribution of specific pandemic vaccines.
Candidate 'pandemic-like' vaccines must be developed and tested in clinical trials to determine the most optimal formulation and the best vaccination schedule.
This study is designed to test in healthy adults aged above 18 years the reactogenicity and immunogenicity of one and two administrations of a candidate pandemic H5N1 vaccine formulated from Split Virus.
調査の概要
状態
状態
完了
条件
条件
介入・治療
介入・治療
詳細な説明
This study has 2 phases:
The study ID 107064 corresponds to objectives & outcome measures evaluated from day 0 until day 51.
The study ID 107217 corresponds to objectives & outcome measures evaluated at day 180.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
研究の種類
研究の種類
介入
入学 (実際)
入学
5075
段階
段階
- フェーズ 3
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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Tallinn、エストニア、10617
- GSK Investigational Site
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Tartu、エストニア、50417
- GSK Investigational Site
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Rotterdam、オランダ、3011 EN
- GSK Investigational Site
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Rotterdam、オランダ、3015 GE
- GSK Investigational Site
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Eskilstuna、スウェーデン、SE-631 88
- GSK Investigational Site
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Stockholm、スウェーデン、SE-141 86
- GSK Investigational Site
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Barcelona、スペイン、08036
- GSK Investigational Site
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Barcelona、スペイン、08035
- GSK Investigational Site
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Madrid、スペイン、28041
- GSK Investigational Site
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Madrid、スペイン、28006
- GSK Investigational Site
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Madrid、スペイン、28040
- GSK Investigational Site
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Marid、スペイン、28040
- GSK Investigational Site
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Valencia、スペイン、46017
- GSK Investigational Site
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Valencia、スペイン、46014
- GSK Investigational Site
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Berlin、ドイツ、14057
- GSK Investigational Site
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Berlin、ドイツ、10117
- GSK Investigational Site
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Berlin、ドイツ、10787
- GSK Investigational Site
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Hamburg、ドイツ、22143
- GSK Investigational Site
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Hamburg、ドイツ、20249
- GSK Investigational Site
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Bayern
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Muenchen、Bayern、ドイツ、81667
- GSK Investigational Site
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Muenchen、Bayern、ドイツ、80799
- GSK Investigational Site
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Regensburg、Bayern、ドイツ、93053
- GSK Investigational Site
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Wuerzburg、Bayern、ドイツ、97070
- GSK Investigational Site
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Mecklenburg-Vorpommern
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Schwerin、Mecklenburg-Vorpommern、ドイツ、19055
- GSK Investigational Site
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Niedersachsen
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Hannover、Niedersachsen、ドイツ、30519
- GSK Investigational Site
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Nordrhein-Westfalen
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Witten、Nordrhein-Westfalen、ドイツ、58455
- GSK Investigational Site
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Sachsen
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Dresden、Sachsen、ドイツ、01067
- GSK Investigational Site
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Leipzig、Sachsen、ドイツ、04229
- GSK Investigational Site
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Leipzig、Sachsen、ドイツ、04103
- GSK Investigational Site
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Caen cedex 4、フランス、14052
- GSK Investigational Site
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Lagord、フランス、17140
- GSK Investigational Site
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Nantes、フランス、44093
- GSK Investigational Site
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Paris Cedex 18、フランス、75877
- GSK Investigational Site
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Poitiers、フランス、86000
- GSK Investigational Site
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Rouen、フランス、76100
- GSK Investigational Site
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Ekaterinburg、ロシア連邦、620078
- GSK Investigational Site
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Ekaterinburg、ロシア連邦、620028
- GSK Investigational Site
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Kazan、ロシア連邦、420015
- GSK Investigational Site
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Novokuznetsk、ロシア連邦、654063
- GSK Investigational Site
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Saratov、ロシア連邦
- 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
適格基準
就学可能な年齢
18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 will comply with the requirements of the protocol.
- A male or female aged 18 years or above at the time of the first vaccination.
- Written informed consent obtained from the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- If the subject is female, she must be of non-childbearing potential, for 30 days prior to first vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
Exclusion Criteria:
- 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 the second vaccination.
- Administration of interpandemic influenza vaccine between Day 0 and Day 51of the study. Those study participants belonging to risk groups eligible to receive the annual interpandemic influenza vaccine (in accordance with local regulations) can receive the annual vaccination after day 51 and before the end of the study on Day 180.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first administration of the study vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- History of chronic alcohol consumption and/or drug abuse.
- History of hypersensitivity to vaccines.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Major congenital defects or serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination. (Subjects suffering from seasonal allergies or asthma under inhalative treatment can be included).
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the first administration of the study vaccine or during the study.
- Lactating women
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to the first vaccination, or planned use during the study period.
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
アーム数
2
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
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実験的：GSK1562902A Group
Male and female subjects aged 18 or over received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
The group was further stratified by age for analyses.
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2 doses, intramuscular injection
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アクティブコンパレータ：Fluarix+Placebo Group
Male and female subjects aged 18 or over received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
The group was further stratified by age for analyses.
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One intramuscular injection
One 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
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 Solicited Local Symptoms
時間枠：During a 7 day follow-up period after each dose of vaccine and overall.
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Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling.
Any = occurrence of symptom regardless of intensity grade.
Grade 3 Pain = pain that prevented normal everyday activities Grade 3 ecchymosis/induration/redness/swelling = redness/swelling spreading beyond (>) 50 millimeters (mm) in diameter
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During a 7 day follow-up period after each dose of vaccine and overall.
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Number of Subjects With Solicited General Symptoms (Dose 1)
時間枠：During the 7-day (Days 0-6) after Dose 1
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Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering, sweating.
Any = occurrence of symptom regardless of intensity grade and relationship to vaccination.
Grade 3 symptom = symptoms that prevented normal activity.
Grade 3 Fever = fever higher than (>) 39.0 °C.
Related = symptom considered by the investigator to be casually related with the study vaccination.
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During the 7-day (Days 0-6) after Dose 1
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Number of Subjects With Solicited General Symptoms (Dose 2)
時間枠：During the 7-day (Days 0-6) after Dose 2
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Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering, sweating.
Any = occurrence of symptom regardless of intensity grade and relationship to vaccination.
Grade 3 symptom = symptoms that prevented normal activity.
Grade 3 Fever = fever higher than (>) 39.0 °C.
Related = symptom considered by the investigator to be casually related with the study vaccination.
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During the 7-day (Days 0-6) after Dose 2
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Number of Subjects With Solicited General Symptoms (Across Doses)
時間枠：During the 7-day (Days 0-6) post vaccination across dosses
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Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering, sweating.
Any = occurrence of symptom regardless of intensity grade and relationship to vaccination.
Grade 3 symptom = symptoms that prevented normal activity.
Grade 3 Fever = fever higher than (>) 39.0 °C.
Related = symptom considered by the investigator to be casually related with the study vaccination.
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During the 7-day (Days 0-6) post vaccination across dosses
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Number of Subjects With Unsolicited Adverse Events (AEs)
時間枠：During the 21st Day (Days 0-20) post Dose 1
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An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Grade 3 AE = an AE which prevented normal, everyday activities.
Related = AE assessed by the investigator as related to the vaccination.
Related symptoms were not available.
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During the 21st Day (Days 0-20) post Dose 1
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Number of Subjects With AEs
時間枠：During the 30 Day (Days 0-29) post Dose 2
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An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Grade 3 AE = an AE which prevented normal, everyday activities.
Related = AE assessed by the investigator as related to the vaccination.
Related symptoms were not available.
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During the 30 Day (Days 0-29) post Dose 2
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Number of Subjects With Serious Adverse Events (SAEs)
時間枠：From Day 0 to Day 180
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SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
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From Day 0 to Day 180
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Number of Subjects With New Onset Chronic Diseases (NOCDs)
時間枠：From Day 0 to Day 180
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NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.
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From Day 0 to Day 180
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Number of Subjects With Medically Significant Conditions (MSCs)
時間枠：From Day 0 to Day 51
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MSCs prompting emergency room or physician visits that were not related to common diseases or routine visits.
Common diseases included upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
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From Day 0 to Day 51
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二次結果の測定
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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Anti- Haemagglutinin Antibody (Anti-HA) Titers Against Avian Influenza A Subtype H5N1
時間枠：At Day 0 (PRE), 21 and 42
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Anti-HA antibody titers were expressed as Geometric Mean Tiyers (GMTs).
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At Day 0 (PRE), 21 and 42
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Number of Seroconverted Subjects Against H5N1
時間枠：At Day 21 and Day 42
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Seroconversion rate for Haemagglutinin antibody response was defined as the number of vaccinees who had either a pre-vaccination titer lower 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 fourfold increase in post-vaccination titer.
Seroconversion rate for Neutralising antibody response was defined as the percentage of vaccinees with a minimum 4-fold increase in titer at post-vaccination.
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At Day 21 and Day 42
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Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam Influenza Strain
時間枠：At Day 21 and Day 42
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Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to day 0.
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At Day 21 and Day 42
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Number of Seroprotected Subjects Against A/Vietnam Influenza Strain
時間枠：At Day 0 (PRE), Day 21 and Day 42
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Seroprotection rate was defined as the number of vaccinees with a serum HI titer ≥1:40 that usually is accepted as indicating protection.
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At Day 0 (PRE), Day 21 and Day 42
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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。
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 (実際)
研究開始
2006年5月1日
一次修了 (実際)
一次修了
2007年1月1日
研究の完了 (実際)
研究の完了
2007年7月31日
試験登録日
最初に提出
最初に提出
2006年4月26日
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
2006年4月26日
最初の投稿 (見積もり)
最初の投稿
2006年4月27日
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
2018年7月23日
QC基準を満たした最後の更新が送信されました
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28日
最終確認日
最終確認日
2017年4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
その他の研究ID番号
- 107064
- 107217 (その他の識別子：GSK)
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：107064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：107064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：107064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：107064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：107064情報コメント：For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 107064 are summarised with study 107217 on the GSK Clinical Study Register.
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統計分析計画
情報識別子：107064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。