A Study of Updated mRNA Seasonal Influenza Vaccines
A Phase 3b/4 Study to Assess the Immunogenicity and Safety of Updated mRNA Seasonal Influenza Vaccine Compositions
The purpose of this study is to evaluate the immunogenicity and safety of updated strain-containing compositions of the mRNA-1010 vaccines within the current epidemiological environment.
調査の概要
詳細な説明
This study uses a master protocol with a generic study design to allow flexibility in evaluating immunogenicity and safety of updated strain-containing compositions of the mRNA-1010 vaccines. As different strain-containing vaccine compositions will be evaluated, each study intervention will be described in the subprotocol. For each evaluation of an updated strain, a new subprotocol will be generated. Reported outcome measures are based upon each subprotocol. Not all reported outcome measures may be applicable to each subprotocol.
Subprotocol 01 is to evaluate the 2026-2027 mRNA influenza vaccine.
研究の種類
入学 (推定)
段階
- フェーズ 4
連絡先と場所
研究連絡先
- 名前：Moderna WeCare Team
- 電話番号：1-866-663-3762
- メール：WeCareClinicalTrials@modernatx.com
研究場所
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Arizona
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Tucson、Arizona、アメリカ、85711
- 募集
- Arizona Clinical Trials
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Kansas
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Lenexa、Kansas、アメリカ、66219
- 募集
- Johnson County Clin-Trials LLC (JCCT)
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Kentucky
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Louisville、Kentucky、アメリカ、40205
- 募集
- DelRicht Research at Derby City Direct Primary Care
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Missouri
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Town and Country、Missouri、アメリカ、63017
- 募集
- DelRicht Research at Amy Roberts MD and Associates
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Key Inclusion Criteria:
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
- Female participants must be of non-childbearing potential.
Key Exclusion Criteria:
- Acutely ill or febrile (temperature ≥38.0 degrees Celsius (℃) [100.4° Fahrenheit [F]]) within 72 hours prior to at the Screening Visit or Day 1.
- History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any mRNA vaccine or therapeutic or any components of an mRNA vaccine or therapeutic
- History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable, potentially affects participant safety, could interfere with interpretation of study results or limit the participant's participation in the study.
- History of myocarditis, pericarditis, or myopericarditis within 90 days prior to Day 1 (Baseline).
- Received corticosteroids at ≥10 mg/day of prednisone or equivalent for >14 days in total within 90 days prior to Day 1 (Baseline) or within 28 days after Day 1.
- Received systemic immunosuppressive treatment, including long-acting biological therapies that affect immune responses (eg, infliximab), within 180 days prior to Day 1 (Baseline) or plans to do so during the study.
- Tested positive for influenza by US Centers for Disease Control and Prevention (CDC)-recommended testing methods within 180 days prior to Day 1.
- Received systemic immunoglobulins or blood products within 90 days prior to Day 1 (Baseline) or plans to do so during the study.
- Received any vaccine (excluding seasonal influenza vaccine) authorized or approved by local health agency within 28 days prior to Day 1 (Baseline) or plans to do so within 14 days after Day 1 (Baseline).
- Received a licensed or investigational seasonal influenza vaccine within 6 months prior to Day 1 (Baseline) or plans to do so (outside of this study) at any time during the study.
研究計画
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 |
|---|---|
|
実験的：mRNA-1010 Influenza Strain-containing Composition (2026- 2027)
Participants will receive a single dose of mRNA-1010 by intramuscular (IM) injection on Day 1. |
Sterile liquid for injection |
|
アクティブコンパレータ：Licensed High-Dose Seasonal Influenza Vaccine
Participants will receive a single dose of licensed high-dose seasonal influenza vaccine by IM injection on Day 1. |
Sterile liquid for injection |
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 |
|---|---|---|
|
血球凝集阻害（HAI）アッセイによって測定された、29日目の抗ヘマグルチニン（HA）抗体の幾何平均力価（GMT）
時間枠：29日目
|
29日目
|
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Number of Participants Reaching Seroconversion at Day 29 as Measured by HAI Assay
時間枠：Day 29
|
Seroconversion is defined as a Day 29 titer ≥1:40 if baseline is <1:10 or a 4-fold or greater rise if baseline is ≥1:10 in anti-HA antibodies measured by HAI assay. |
Day 29
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Number of Participants with an HAI Titer ≥1:40 at Day 29
時間枠：Day 29
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Day 29
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Geometric Mean Fold Rise (GMFR), as Measured by HAI Assay
時間枠：Baseline to Day 29
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Baseline to Day 29
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Number of Participants with Unsolicited Adverse Events (AEs)
時間枠：Day 1 through Day 29
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Day 1 through Day 29
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Number of Participants with Serious AEs, Medical-attended AEs and AE of Interest, and AEs Leading to Discontinuation
時間枠：Day 1 through Day 29
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Day 1 through Day 29
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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
- mRNA-1010-P401
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?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。