Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Influenza Vaccine(s) GSK3277510A and GSK3277509A in Adults 18 to 60 Years of Age
2016年6月16日 更新者:GlaxoSmithKline
An Observer-blind Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine(s) GSK3277510A and GSK3277509A Administered in Adults 18 to 60 Years of Age
The purpose of this study is to evaluate the safety and immunogenicity of different formulations of GSK Biologicals' H7N9 influenza vaccine in subjects 18 to 60 years of age.
調査の概要
状態
引きこもった
条件
研究の種類
介入
段階
- フェーズ 1
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:
- Male or female adults who are 18 to 60years of age (inclusive) at the time of first study vaccination.
- Written informed consent obtained from subject.
- Subjects who the investigator believes can and will comply with the requirements of the protocol.
- Healthy subjects as established by medical history and physical examination.
- Access to a consistent means of telephone contact.
- For subjects who undergo a screening visit: Results of screening safety laboratory tests that figure in eligibility assessment must be within reference ranges before dosing.
- Female subjects of non-childbearing potential may be enrolled in the study.
Female subjects of childbearing potential may be enrolled in the study, if they
- have practiced adequate contraception for 30 days prior to vaccination, and
- have a negative pregnancy test on the day of vaccination, and agree to continue to practice adequate contraception until 2 months after the last dose administered.
Exclusion Criteria:
- Presence or evidence of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
- Presence or evidence of substance abuse.
- Diagnosed with cancer, or treatment for cancer within three years.
- Diagnosed with excessive daytime sleepiness, or narcolepsy; or history of narcolepsy in a subject's parent, sibling or child.
- Presence of a temperature ≥ 38.0ºC (≥100.4ºF), or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
- Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
- Receipt of systemic glucocorticoids within 30 days prior to the first dose of study vaccine/placebo, or any other cytotoxic, immunosuppressive or immune-modifying drugs within 6 months of first study vaccine/ placebo dose.
- Any significant disorder of coagulation or treatment with warfarin derivatives or heparin.
- An acute evolving neurological disorder or Guillain Barré Syndrome within 42 days of receipt of prior seasonal or pandemic influenza vaccine.
- Administration of an inactive vaccine within 14 days or of a live attenuated vaccine within 30 days before the first dose of study vaccine/placebo.
- Planned administration of any vaccine other than the study vaccine/placebo before blood sampling at the Day 42 visit.
- Previous administration of any H7 vaccine or physician-confirmed H7 disease.
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine/placebo, or planned use during the study period.
- Receipt of any immunoglobulins and/or any blood products within 90 days before the first dose of study vaccine/placebo, or planned administration of any of these products during the study period.
- Any known or suspected allergy to any constituent of influenza vaccines or component used in the manufacturing process of the study vaccine including a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
- Known pregnancy or a positive urine beta-human chorionic gonadotropin (β-hCG) test result before the first dose of study vaccine/placebo.
- Lactating or nursing women.
- Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
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:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター:プラセボグループ
このグループの被験者は21日間隔でプラセボを2回投与されます。
|
One dose of placebo administered IM at the deltoid region of non-dominant arm at Day 0 and the second dose of placebo administered IM at the deltoid region of dominant arm at Day 21
|
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実験的:Formulation 1 Group
Subjects in this group will receive two doses of GSK3277510A H7N9 vaccine formulation 1 at a 21 day interval
|
One dose of GSK3277510A H7N9 vaccine administered intramuscularly (IM) in the deltoid region of non-dominant arm at Day 0 and the second dose of GSK3277510A H7N9 vaccine administered IM in the deltoid region of dominant arm at Day 21
|
|
実験的:Formulation 2 Group
Subjects in this group will receive two doses of GSK3277510A H7N9 vaccine formulation 2 at a 21 day interval
|
One dose of GSK3277510A H7N9 vaccine administered intramuscularly (IM) in the deltoid region of non-dominant arm at Day 0 and the second dose of GSK3277510A H7N9 vaccine administered IM in the deltoid region of dominant arm at Day 21
|
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実験的:Formulation 3 Group
Subjects in this group will receive two doses of GSK3277510A H7N9 vaccine formulation 3 at a 21 day interval
|
One dose of GSK3277510A H7N9 vaccine administered intramuscularly (IM) in the deltoid region of non-dominant arm at Day 0 and the second dose of GSK3277510A H7N9 vaccine administered IM in the deltoid region of dominant arm at Day 21
|
|
実験的:Formulation 4 Group
Subjects in this group will receive two doses of GSK3277510A H7N9 vaccine formulation 4 at a 21 day interval
|
One dose of GSK3277510A H7N9 vaccine administered intramuscularly (IM) in the deltoid region of non-dominant arm at Day 0 and the second dose of GSK3277510A H7N9 vaccine administered IM in the deltoid region of dominant arm at Day 21
|
|
実験的:Formulation 5 Group
Subjects in this group will receive two doses of GSK3277509A H7N9 vaccine formulation 5 at a 21 day interval
|
One dose of GSK3277509A H7N9 vaccine administered IM at the deltoid region of non-dominant arm at Day 0 and the second dose of GSK3277509A H7N9 vaccine administered IM at the deltoid region of dominant arm at Day 21
|
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 |
時間枠 |
|---|---|
|
Humoral immune response in terms of vaccine-homologous hemagglutination inhibition (HI) antibody titers
時間枠:At Day 42.
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At Day 42.
|
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Occurrence of each solicited local symptom
時間枠:During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccination.
|
During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccination.
|
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Occurrence of each solicited general symptom
時間枠:During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccination.
|
During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccination.
|
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Occurrence of clinical safety laboratory abnormalities reported for samples
時間枠:At the Day 0, 7, 21, 28 and 42 visits.
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At the Day 0, 7, 21, 28 and 42 visits.
|
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Occurrence of unsolicited adverse events (AEs)
時間枠:21 days after each dose.
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21 days after each dose.
|
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Occurrence of Medically Attended Adverse Events (MAEs), potential Immune Mediated Diseases (pIMDs) and Serious Adverse Events (SAEs)[Active Phase]
時間枠:From Day 0 until Day 42.
|
From Day 0 until Day 42.
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Evaluation of adjuvant effect as assessed by vaccine-homologous hemagglutination inhibition (HI) antibody titers
時間枠:At Day 42.
|
At Day 42.
|
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Humoral immune response in terms of vaccine-homologous hemagglutination inhibition (HI) antibody titers for plain antigen vaccine group
時間枠:At Day 42.
|
At Day 42.
|
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Humoral immune response in terms of vaccine-homologous (H7N9) HI antibody titers.
時間枠:GMTs and Seropositivity rates at Days 0, 21, 42 and Months 6 and 12. SCR and MGI at Days 21, 42 (Placebo group only) and Months 6 and 12. SPR at Days 0, 21, 42 (Placebo group only) and Months 6 and 12.
|
GMTs and Seropositivity rates at Days 0, 21, 42 and Months 6 and 12. SCR and MGI at Days 21, 42 (Placebo group only) and Months 6 and 12. SPR at Days 0, 21, 42 (Placebo group only) and Months 6 and 12.
|
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Humoral immune response in terms of vaccine-homologous (H7N9) neutralizing (MN) antibody titres.
時間枠:GMTs and Seropositivity rates at the Days 0, 21, 42 and Month 6 visits. VRR at Days 21, 42 and Month 6 visits.
|
GMTs and Seropositivity rates at the Days 0, 21, 42 and Month 6 visits. VRR at Days 21, 42 and Month 6 visits.
|
|
Humoral immune response in terms of vaccine-homologous (H7N9) HI antibody titers by age stratum.
時間枠:GMTs, Seropositivity rates and SPR at Days 0, 21, 42 and Months 6 and 12. SCR and MGI at Days 21, 42 and Months 6 and 12.
|
GMTs, Seropositivity rates and SPR at Days 0, 21, 42 and Months 6 and 12. SCR and MGI at Days 21, 42 and Months 6 and 12.
|
|
Humoral immune response in terms of vaccine homologous (H7N9) neutralizing (MN) antibody titers for each study group by age stratum (18-40 years; 41-60 years)
時間枠:GMTs and Seropositivity rates at Days 0, 21, 42 and Month 6. VRR at Days 21, 42 and Month 6.
|
GMTs and Seropositivity rates at Days 0, 21, 42 and Month 6. VRR at Days 21, 42 and Month 6.
|
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Occurrence of MAEs, pIMDs and SAEs
時間枠:Until the Month 12 visit.
|
Until the Month 12 visit.
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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
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
2016年3月1日
一次修了 (予想される)
2016年6月1日
研究の完了 (予想される)
2017年5月1日
試験登録日
最初に提出
2014年6月19日
QC基準を満たした最初の提出物
2014年6月26日
最初の投稿 (見積もり)
2014年6月30日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年6月20日
QC基準を満たした最後の更新が送信されました
2016年6月16日
最終確認日
2016年6月1日
詳しくは
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。