Post Marketing Surveillance Study for MenQuadfi® [Meningococcal (Groups A, C, Y, W) Polysaccharide Tetanus Toxoid Conjugate Vaccine] Administered in Participants Aged 6 Weeks to 55 Years in Republic of Korea
This surveillance is to investigate the safety profile of MenQuadfi®, when administered to participants aged 6 weeks to 55 years under the real-world clinical practice settings as per approved indications, including the Adverse Drug Reactions (ADRs)*.
*It includes ADRs that were not fully recognized in clinical practice, or unexpected ADRs which refer to those not listed in the approved drug labeling.
調査の概要
状態
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Trial Transparency email recommended (Toll free for US & Canada)
- 電話番号：option 6 800-633-1610
- メール：contact-us@sanofi.com
研究場所
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Busan、韓国、49408
- 募集
- Investigational Site Number: 410009
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Daegu、韓国、41794
- 募集
- Investigational Site Number: 410011
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Goyang、韓国、10234
- 募集
- Investigational Site Number: 410003
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Gwangju、韓国、61665
- 募集
- Investigational Site Number: 410008
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Hanam、韓国、12919
- 募集
- Investigational Site Number: 410010
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Iksan、韓国、54639
- 募集
- Investigational Site Number: 410006
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Seongnam、韓国、13558
- 募集
- Investigational Site Number: 410005
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Seoul、韓国、06132
- 募集
- Investigational Site Number: 410004
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Seoul、韓国、06614
- 募集
- Investigational Site Number: 410007
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
This is a multi-center, observational cohort active safety surveillance study, designed to be conducted under standard healthcare setting of the Republic of Korea, in accordance with "Standard for Re-examination of New Drugs".
This is a single country study which will be conducted only in Korea with a target number of 706 participants.
Investigators will recruit participants until the targeted number of participants (as contracted with the sponsor) has been obtained; each participant will be assigned an identification number in the order of enrollment.
説明
Inclusion Criteria:
- Aged 6 weeks to 55 years on the day of MenQuadfi® vaccination
- Evidence of a personally signed and dated informed consent document indicating that the participant or their parent(s)/other legally acceptable representative(s), if applicable, have been informed of all pertinent aspects of the study
- Participants who have been vaccinated with MenQuadfi® for the first time as per ordinary healthcare setting at the day of inclusion in the study according to the approved local product label
Exclusion Criteria:
- Participating or planning participation in any other clinical studies investigating a vaccine, drug, medical device, or medical procedure at the time of the study enrolment (or in 4 weeks preceding the enrolment)
- Having a previous history of enrollment in this study (participants who have already been enrolled once in this study are not eligible for re-enrollment)
- Being applicable to contraindications in the approved local product label of MenQuadfi®; anyone with a known systemic hypersensitivity reaction to any component of this vaccine or after previous administration of the vaccine or a vaccine containing the same components
Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
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
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Participants aged 6 weeks to 55 years old
Participants vaccinated with MenQuadfi® for the first time as per ordinary healthcare setting at the day of inclusion
|
This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.
他の名前：
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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
結果測定 |
時間枠 |
|---|---|
|
Number of participants with solicited injection site and systemic reactions
時間枠：Up to 7 days after vaccination
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Up to 7 days after vaccination
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Number of participants with unsolicited non-serious Adverse Events (AEs) and Adverse Drug Reactions (ADRs), including unexpected AEs and ADRs
時間枠：Up to 30 days after vaccination
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Up to 30 days after vaccination
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Number of participants with Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI), and Serious Adverse Drug Reactions (SADRs)
時間枠：From Day 01 up to the end of the study (approximately 44 days after inclusion in individuals aged 2-55 years; approximately 4 months in infants aged 6 months to <24 months; approximately 13 months in infants aged 6 weeks to <6 months)
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From Day 01 up to the end of the study (approximately 44 days after inclusion in individuals aged 2-55 years; approximately 4 months in infants aged 6 months to <24 months; approximately 13 months in infants aged 6 weeks to <6 months)
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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
その他の研究ID番号
- MEQ00085
- U1111-1317-8004 (レジストリ識別子：ICTRP)
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?
IPD プランの説明
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。