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治験 NCT05450705（対象：パピローマウイルス感染症）は実施中／登録終了です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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MSDV503 in Chinese Girls 9-14 Years Old Versus Chinese Women 20-26 Years Old (V503-071) 第III相・フェーズ3 1,500 ワクチン
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT05450705 は パピローマウイルス感染症 に関する 予防 の研究で、第III相・フェーズ3 介入研究 臨床試験 です。現在は 実施中／登録終了 で、2022年7月22日 から開始しています。1,500 名の参加者 の募集が計画されています。この試験は MSD によって主導され、2029年8月3日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2022年9月2日 です。
概要
This study aims to demonstrate that a 2-dose regimen of the 9-Valent Human Papillomavirus (9vHPV) vaccine (GARDASIL™9, V503) induces non-inferior competitive Luminex immunoassay (cLIA) geometric mean titers (GMTs) to each of the 9vHPV vaccine types in Chinese girls 9 through 14 years of age compared to a 3-dose regimen in Chinese women 20 through 26 years of age. The primary hypothesis is that a 2-dose regimen has a ...もっと見る
公式タイトル
A Phase 3 Open-Label Immunogenicity and Safety Study of 2-Dose Regimens of a 9vHPV Vaccine (V503) in Chinese Girls 9 Through 14 Years of Age With a Comparison to 3-Dose Regimen of V503 in Chinese Women 20 Through 26 Years of Age
疾患名
パピローマウイルス感染症その他の研究識別子
- V503-071
- V503-071 (その他の識別子) (Merck)
NCT番号
開始日
2022-07-22
最終更新日
2022-09-02
終了予定日
2029-08-03
目標参加者数
1,500
試験の種類
介入研究
治験の相・段階
第III相・フェーズ3
状況
実施中／登録終了
主目的
予防
割付方法
無作為化
介入モデル
並行割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的9 to 14 Years Old: Day 1 and Month 6 Chinese females 9 to 14 years old will receive a 0.5 mL intramuscular (IM) injection of 9-valent HPV (9vHPV) vaccine on Day 1 and Month 6 | 9vHPV vaccine A 9-valent HPV vaccine (Types 6, 11, 16, 18, 31, 33, 45, 52, and 58) will be administered as a 0.5 mL IM injection. |
実験的9 to 14 Years Old: Day 1 and Month 12 Chinese females 9 to 14 years old will receive a 0.5 mL iIM injection of 9-valent HPV (9vHPV) vaccine on Day 1 and Month 12 | 9vHPV vaccine A 9-valent HPV vaccine (Types 6, 11, 16, 18, 31, 33, 45, 52, and 58) will be administered as a 0.5 mL IM injection. |
実験的20 to 26 Years Old: Day 1, Month 2 and Month 6 Chinese females 20 to 26 years old will receive a 0.5 mL IM injection of 9-valent HPV (9vHPV) vaccine on Day 1, Month 2 and Month 6 | 9vHPV vaccine A 9-valent HPV vaccine (Types 6, 11, 16, 18, 31, 33, 45, 52, and 58) will be administered as a 0.5 mL IM injection. |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Stage I: Competitive Luminex immunoassay (cLIA) Geometric Mean Titers (GMTs) to 9 vaccine types of 9vHPV vaccine | cLIA GMT to each of 9 vaccine types of 9vHPV vaccine. The GMT for each HPV type will be reported in mMU/mL. | One month after last dose (Up to Month 13) |
Stage II: cLIA GMTs to 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age | cLIA GMT to each of 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age. The GMT for each HPV type will be reported in mMU/mL. | Up to Month 84 |
Stage II: cLIA seropositivity percentages to 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age | cLIA seropositivity to each of 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age. The percentage of participants who are seropositive for each HPV type will be summarized. | Up to Month 84 |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Stage I: cLIA seroconversion percentages to 9 vaccine types of 9vHPV vaccine | cLIA seroconversion to each of 9 vaccine types of 9vHPV vaccine. The percentage of participants who are seropositive for each HPV type will be summarized. | One month after last dose (Up to Month 13) |
Stage I: Immunoglobulin G Luminex immunoassay (IgG LIA) GMTs to 9 vaccine types of 9vHPV vaccine at one month post last dose | IgG LIA GMT to each of 9 vaccine types of 9vHPV vaccine at one month post last dose. The GMT for each HPV type will be reported in mMU/mL. | One month after last dose (Up to Month 13) |
Stage I: IgG LIA seroconversion percentages to 9 vaccine types of 9vHPV vaccine | IgG LIA seroconversion to each of 9 vaccine types of 9vHPV vaccine. The percentage of participants who are seropositive for each HPV type will be summarized. | One month after last dose (Up to Month 13) |
Stage I: Percentage of participants experiencing solicited injection-site adverse events (AEs) | An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Solicited injection-site AEs such as erythema, swelling, pain, and induration at the injection site will be recorded. | Day 1 through Day 8 following any study vaccination |
Stage I: Percentage of participants experiencing solicited systemic AEs | An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Systemic AEs are those not categorized as injection-site AEs. | Day 1 through Day 8 following any study vaccination |
Stage I: Percentage of participants experiencing serious AEs (SAEs) Up to Month 13 | A SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event. | Up to Month 13 |
Stage II: Percentage of participants experiencing SAEs Up to Month 84 | A SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event. | Month 18 up to Month 84 |
Stage II: IgG LIA GMTs to 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age | IgG LIA GMT to each of 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age. The GMT for each HPV type will be reported in mMU/mL. | Up to Month 84 |
Stage II: IgG LIA seropositivity percentages to 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age | IgG LIA seropositivity to each of 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age. The percentage of participants who are seropositive for each HPV type will be summarized | Up to Month 84 |
参加アシスタント
適格基準
対象年齢
小児, 成人
試験の最低年齢
9 Years
対象性別
女性
健康なボランティアを受け入れる
はい
INCLUSION CRITERIA:
- Is a healthy Chinese female.
- Is not a woman of childbearing potential (WOCBP); or is a WOCBP who has not had sex with males or has had sex with males and used effective contraception during Day 1 through 1 month post last dose.
Exclusion Criteria:
- Has a history of known prior vaccination with an HPV vaccine.
- Has a history of severe allergic reaction that required medical intervention.
- Has a known thrombocytopenia or coagulation disorder that would contraindicate IM injections.
- Has a history of abnormal Pap test or external genital wart, vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, anal intraepithelial neoplasia, vulvar cancer, vaginal cancer, or anal cancer.
- Has a history of a positive test for HPV.
- Has received immune globulin or blood-derived products in the past 6 months or plans to receive any before one month post last dose.
- Has a history of splenectomy, is currently immunocompromised, or has been diagnosed with immunodeficiency, human immunodeficiency virus, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition.
- Has received immunosuppressive therapy in the past year, excluding inhaled, nasal, or topical corticosteroids and certain regimens of systemic corticosteroids.
MSD連絡先情報がありません。
2 1カ国の場所
Zhejiang
Jiangshan Center for Disease Control and Prevention ( Site 0001), Quzhou, Zhejiang, 324100, China
Yuhuan Center for Disease Control and Prevention ( Site 0002), Taizhou, Zhejiang, 317600, China