A Clinical Study of V503 in Chinese Females Who Have Previously Received a Bivalent Human Papillomavirus (HPV) Vaccine (V503-108)
2026年9月3日 更新者：Merck Sharp & Dohme LLC
A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Immunogenicity and Safety of V503 in Chinese Females Aged 10 to 45 Years Who Have Previously Received a Bivalent Human Papillomavirus (HPV) Vaccine
Researchers want to learn if V503 (also called the 9-valent human papillomavirus [9vHPV] vaccine, recombinant) can induce an immune response to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Chinese females who previously received the bivalent HPV (2vHPV) vaccine.
The 9vHPV vaccine protects against diseases caused by 9 types of HPV (6, 11, 16, 18, 31, 33, 45, 52, and 58) and the 2vHPV vaccine protects against diseases caused by 2 types of HPV (16 and 18).
The goals of the trial are to learn:
- If the 9vHPV vaccine can induce an immune response to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in participants who received the 2vHPV vaccine
- About the safety of the 9vHPV vaccine in prior 2vHPV vaccine recipients
調査の概要
研究の種類
介入
入学 (推定)
930
段階
- フェーズ 3
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
- 子
- 大人
健康ボランティアの受け入れ
はい
説明
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
- For participants to be enrolled in prior 2vHPV (bivalent human papillomavirus [HPV] vaccine) vaccine groups: has received at least one dose of any one of the three currently marketed 2vHPV vaccines, with the last dose administered at least one year prior to Day 1.
- For participants to be enrolled in HPV vaccine naïve groups: has never received any HPV vaccine.
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
- Has known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
- Has a history of abnormal Pap test showing low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL) or atypical squamous cells - undetermined significance (ASC-US), atypical squamous cells - cannot exclude HSIL (ASC-H), atypical glandular cells, or biopsy showing CIN, AIS, or cervical cancer.
- Has a history of external genital wart, vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), AIN, vulvar cancer, vaginal cancer, or anal cancer.
- Has a history of a positive test for HPV (including HPV types not in the vaccine).
- Is currently immunocompromised or has been diagnosed as having congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease, or other autoimmune condition.
- Has a history of splenectomy.
- Has received, is receiving, or plans to receive the following immunosuppressive therapies: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide (Arava™), tumor necrosis factor alpha (TNF-α) antagonists, monoclonal antibody therapies (including rituximab [Rituxan™]), intravenous gamma globulin (IVIG), antilymphocyte sera, or other therapy known to interfere with the immune response. With regard to systemic corticosteroids, a participant will be excluded if the participant is currently receiving steroid therapy, has recently (defined as within 2 weeks of enrollment) received such therapy, or has received 2 or more courses of corticosteroids (orally or parenterally) lasting at least 1 week within 12 months prior to enrollment. Participants using inhaled, nasal, or topical corticosteroids are considered eligible for the study.
- Has received, is receiving, or plans to receive any immune globulin product (including RhoGAM™ [Ortho-Clinical Diagnostics]) or blood derived product other than IVIG.
- Has participated in an HPV vaccine clinical trial and has received either active agent or placebo.
- Has received any marketed HPV vaccine other than the 2vHPV vaccines.
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
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Prior 2vHPV Vaccine Recipients Receiving V503
Participants will receive V503 at Day 1, Month 2, and Month 6
|
V503 (9-vHPV vaccine [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58]) administered as a 0.5-mL intramuscular (IM) injection on Day 1, Month 2, and Month 6
他の名前：
|
|
プラセボコンパレーター：Prior 2vHPV Vaccine Recipients Receiving Placebo
Participants will receive Placebo at Day 1, Month 2, and Month 6
|
Saline administered as a 0.5-mL IM injection on Day 1, Month 2, and Month 6
|
|
実験的：HPV Vaccine-Naïve Participants Receiving V503
Participants will receive V503 at Day 1, Month 2, and Month 6
|
V503 (9-vHPV vaccine [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58]) administered as a 0.5-mL intramuscular (IM) injection on Day 1, Month 2, and Month 6
他の名前：
|
|
プラセボコンパレーター：HPV Vaccine-Naïve Participants Receiving Placebo
Participants will receive Placebo at Day 1, Month 2, and Month 6
|
Saline administered as a 0.5-mL IM injection on Day 1, Month 2, and Month 6
|
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 |
|---|---|---|
|
Percentage of Participants Who Are Seropositive by Competitive Luminex Immunoassay (cLIA) to HPV Types 6, 11, 31, 33, 45, 52, and 58 (Month 7)
時間枠：Up to approximately 1 month post vaccination 3 (Up to approximately Month 7)
|
The percentage of participants who are seropositive for HPV types 6, 11, 31, 33, 45, 52, and 58 in the Prior 2vHPV Vaccine Recipients Receiving V503 group will be determined using cLIA.
Seropositivity is defined as having a titer at or above the prespecified seropositivity cutoff for a given HPV type.
|
Up to approximately 1 month post vaccination 3 (Up to approximately Month 7)
|
|
Percentage of Participants Who Experience at Least 1 Solicited Injection-site Adverse Event (AE)
時間枠：Up to approximately Day 8 post any vaccination
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
AEs such as redness/erythema, swelling, pain, and induration at the injection site are recorded.
The percentage of participants who experience 1 or more injection-site AE will be reported.
|
Up to approximately Day 8 post any vaccination
|
|
Percentage of Participants Who Experience at Least 1 Solicited Systemic AE
時間枠：Up to approximately Day 8 post any vaccination
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Systemic AEs are those not categorized as injection-site AEs.
The percentage of participants who experience 1 or more systemic AE will be reported.
|
Up to approximately Day 8 post any vaccination
|
|
Percentage of Participants Who Experience at Least 1 Serious AE (SAE)
時間枠：Up to approximately Month 12
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
An 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.
The percentage of participants who experience 1 or more SAEs will be reported.
|
Up to approximately Month 12
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percentage of Participants Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
時間枠：Up to approximately 1 month post vaccination (Up to approximately 7 months)
|
The percentage of participants who are seropositive for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 will be determined using cLIA.
Seropositivity is defined as having a titer at or above the prespecified seropositivity cutoff for a given HPV type.
|
Up to approximately 1 month post vaccination (Up to approximately 7 months)
|
|
cLIA Geometric Mean Titers (GMTs) for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
時間枠：Up to approximately 1 month post vaccination (Up to approximately 7 months)
|
Antibodies to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 will be measured using a cLIA.
Antibody titers will be expressed as milli Merck Units/milliliter (mMU/mL).
|
Up to approximately 1 month post vaccination (Up to approximately 7 months)
|
|
Difference in Percentage of Participants Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 Between Prior 2vHPV Vaccine Recipients and HPV Vaccine-Naïve Participants
時間枠：Up to approximately 1 month post vaccination (Up to approximately 7 months)
|
The percentage of participants who are seropositive for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 will be determined using cLIA.
Seropositivity is defined as having a titer at or above the prespecified seropositivity cutoff for a given HPV type.
The difference in seropositivity percentages between participants who previously received a 2vHPV vaccine and subsequently receive V503 and participants who were HPV vaccine-naïve and receive V503 will be evaluated.
|
Up to approximately 1 month post vaccination (Up to approximately 7 months)
|
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
捜査官
- スタディディレクター：Medical Director、Merck Sharp & Dohme LLC
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 (推定)
2026年10月9日
一次修了 (推定)
2027年12月18日
研究の完了 (推定)
2028年12月22日
試験登録日
最初に提出
2026年8月21日
QC基準を満たした最初の提出物
2026年8月21日
最初の投稿 (実際)
2026年8月25日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月4日
QC基準を満たした最後の更新が送信されました
2026年9月3日
最終確認日
2026年9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
- V503-108
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
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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
いいえ
米国FDA規制機器製品の研究
いいえ
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