A Phase III Study of a 2-dose Regimen of a Multivalent Human Papillomavirus (HPV) Vaccine (V503), Administered to 9 to 14 Year-olds and Compared to Young Women, 16 to 26 Years Old (V503-010)
2018年7月12日 更新者：Merck Sharp & Dohme LLC
A Phase III Clinical Trial to Study the Tolerability and Immunogenicity of a 2-dose Regimen of V503, a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, Administered in Preadolescents and Adolescents (9 to 14 Year Olds) With a Comparison to Young Women (16 to 26 Year Olds)
This was a 37-month safety and immunogenicity study conducted in boys and girls 9 to 14 years of age and in young women 16 to 26 years of age.
From this study, the goal was to establish that the investigational 2-dose regimens (0, 6 months and 0, 12 months) studied in boys and girls 9 to 14 years of age are generally safe and immunogenic, with an antibody response that is not inferior to that observed in young women 16 to 26 years of age who received the standard 3-dose regimen of V503 (i.e., the population and dose regimen used to establish V503 efficacy).
調査の概要
状態
完了
研究の種類
介入
入学 (実際)
1518
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
9年～26年 (子、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:
All Participants:
-Judged to be in good physical health on the basis of medical history, physical examination and laboratory results
Boys and Girls 9 to 14 Years:
-Must not have had coitarche and does not plan on becoming sexually active during the vaccination period
Women 16 to 26 Years:
- Has never had a Papanicolaou (Pap) test or only had normal Pap test results
- A lifetime history of 0 to 4 male and/or female sexual partners
Exclusion Criteria:
All Participants:
- Known allergy to any vaccine component
- History of severe allergic reaction that required medical intervention
- Thrombocytopenia or any coagulation disorder
- Females only: participant is pregnant or expecting to donate eggs during day 1 through month 7
- Currently immunocompromised, or been diagnosed with immunodeficiency
- Had a splenectomy
- Receiving or has received immunosuppressive therapies within the last year
- Received any immunoglobulin product or blood-derived product within 3 months
- Received a marketed HPV vaccine or has participated in an HPV vaccine clinical trial
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：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Girls 9 to 14 Years V503 at Months 0 and 6
Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6.
An additional dose of V503 0.5 mL IM was administered at Month 36.
|
V503, a 9-valent HPV (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection
|
|
実験的：Boys 9 to 14 Years V503 at Months 0 and 6
Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6.
An additional dose of V503 0.5 mL IM was administered at Month 36.
|
V503, a 9-valent HPV (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection
|
|
実験的：Girls and Boys 9 to 14 Years V503 at Months 0 and 12
Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12.
An additional dose of V503 0.5 mL IM was administered at Month 36.
|
V503, a 9-valent HPV (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection
|
|
実験的：Girls 9 to 14 Years V503 at Months 0, 2, and 6
Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6.
An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
|
V503, a 9-valent HPV (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection
|
|
アクティブコンパレータ：Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6.
An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
|
V503, a 9-valent HPV (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular 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 |
|---|---|---|
|
Geometric Mean Titers to Human Papillomavirus (HPV) Type 6 After the Last Dose of V503 in the Planned Regimen
時間枠：4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV virus-like particles (VLP) type 6 were measured using a competitive Luminex immunoassay.
Antibody titers were expressed as milli Merck units/mL (mMU/mL).
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
|
Geometric Mean Titers to HPV Type 11 at Four Weeks After the Last Dose of V503 in the Planned Regimen
時間枠：4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 11 were measured using a competitive Luminex immunoassay.
Antibody titers were expressed as milli Merck units/mL (mMU/mL).
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
|
Geometric Mean Titers to HPV Type 16 at Four Weeks After the Last Dose of V503 in the Planned Regimen
時間枠：4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 16 were measured using a competitive Luminex immunoassay.
Antibody titers were expressed as milli Merck units/mL (mMU/mL).
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
|
Geometric Mean Titers to HPV Type 18 at Four Weeks After the Last Dose of V503 in the Planned Regimen
時間枠：4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 18 were measured using a competitive Luminex immunoassay.
Antibody titers were expressed as milli Merck units/mL (mMU/mL).
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
|
Geometric Mean Titers to HPV Type 31 at Four Weeks After the Last Dose of V503 in the Planned Regimen
時間枠：4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 31 were measured using a competitive Luminex immunoassay.
Antibody titers were expressed as milli Merck units/mL (mMU/mL).
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
|
Geometric Mean Titers to HPV Type 33 at Four Weeks After the Last Dose of V503 in the Planned Regimen
時間枠：4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 33 were measured using a competitive Luminex immunoassay.
Antibody titers were expressed as milli Merck units/mL (mMU/mL).
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
|
Geometric Mean Titers to HPV Type 45 at Four Weeks After the Last Dose of V503 in the Planned Regimen
時間枠：4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 45 were measured using a competitive Luminex immunoassay.
Antibody titers were expressed as milli Merck units/mL (mMU/mL).
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
|
Geometric Mean Titers to HPV Type 52 at Four Weeks After the Last Dose of V503 in the Planned Regimen
時間枠：4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 52 were measured using a competitive Luminex immunoassay.
Antibody titers were expressed as milli Merck units/mL (mMU/mL).
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
|
Geometric Mean Titers to HPV Type 58 at Four Weeks After the Last Dose of V503 in the Planned Regimen
時間枠：4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 58 were measured using a competitive Luminex immunoassay.
Antibody titers were expressed as milli Merck units/mL (mMU/mL).
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percentage of Participants With Seroconversion to HPV Type 6 at Four Weeks After the Last Dose of V503 in the Planned Regimen
時間枠：4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 6 were measured using a competitive Luminex immunoassay.
Seroconversion to HPV type 6 was defined as a titer >=30 mMU/mL.
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
|
Percentage of Participants With Seroconversion to HPV Type 11 at Four Weeks After the Last Dose of V503 in the Planned Regimen
時間枠：4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 11 were measured using a competitive Luminex immunoassay.
Seroconversion to HPV type 11 was defined as a titer >=16 mMU/mL.
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
|
Percentage of Participants With Seroconversion to HPV Type 16 at Four Weeks After the Last Dose of V503 in the Planned Regimen
時間枠：4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 16 were measured using a competitive Luminex immunoassay.
Seroconversion to HPV type 16 was defined as a titer >=20 mMU/mL.
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
|
Percentage of Participants With Seroconversion to HPV Type 18 at Four Weeks After the Last Dose of V503 in the Planned Regimen
時間枠：4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 18 were measured using a competitive Luminex immunoassay.
Seroconversion to HPV type 18 was defined as a titer >=24 mMU/mL.
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
|
Percentage of Participants With Seroconversion to HPV Type 31 at Four Weeks After the Last Dose of V503 in the Planned Regimen
時間枠：4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 31 were measured using a competitive Luminex immunoassay.
Seroconversion to HPV type 31 was defined as a titer >=10 mMU/mL.
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
|
Percentage of Participants With Seroconversion to HPV Type 33 at Four Weeks After the Last Dose of V503 in the Planned Regimen
時間枠：4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 33 were measured using a competitive Luminex immunoassay.
Seroconversion to HPV type 33 was defined as a titer >=8 mMU/mL.
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
|
Percentage of Participants With Seroconversion to HPV Type 45 at Four Weeks After the Last Dose of V503 in the Planned Regimen
時間枠：4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 45 were measured using a competitive Luminex immunoassay.
Seroconversion to HPV type 45 was defined as a titer >=8 mMU/mL.
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
|
Percentage of Participants With Seroconversion to HPV Type 52 at Four Weeks After the Last Dose of V503 in the Planned Regimen
時間枠：4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 52 were measured using a competitive Luminex immunoassay.
Seroconversion to HPV type 52 was defined as a titer >=8 mMU/mL.
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
|
Percentage of Participants With Seroconversion to HPV Type 58 at Four Weeks After the Last Dose of V503 in the Planned Regimen
時間枠：4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
Antibodies to HPV VLP type 58 were measured using a competitive Luminex immunoassay.
Seroconversion to HPV type 58 was defined as a titer >=8 mMU/mL.
|
4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Antibody Persistence: Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 24
時間枠：Month 24
|
Antibodies to HPV VLP types were measured using a competitive Luminex immunoassay.
This outcome measure assessed the long-term persistence of antibody response.
Antibody titers were expressed as milli Merck units/mL (mMU/mL).
|
Month 24
|
|
Antibody Persistence: Percentage of Participants With Seroconversion to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 24
時間枠：Month 24
|
Antibodies to HPV VLP types were measured using a competitive Luminex immunoassay.
This outcome measure assessed the long-term persistence of antibody response.
Seroconversion to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were defined as a titer >=41, 24, 34, 39, 24, 18, 12, 16, and 12 mMU/mL, respectively.
These cutoffs differ from analyses performed on samples collected up to Month 13; the antibody persistence analysis employed a new version of the assay.
|
Month 24
|
|
Antibody Persistence: Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 36
時間枠：Month 36
|
Antibodies to HPV VLP types were measured using a competitive Luminex immunoassay.
This outcome measure assessed the long-term persistence of antibody response.
Antibody titers were expressed as milli Merck units/mL (mMU/mL).
|
Month 36
|
|
Antibody Persistence: Percentage of Participants With Seroconversion to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 36
時間枠：Month 36
|
Antibodies to HPV VLP types were measured using a competitive Luminex immunoassay.
This outcome measure assessed the long-term persistence of antibody response.
Seroconversion to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were defined as a titer >=41, 24, 34, 39, 24, 18, 12, 16, and 12 mMU/mL, respectively.
These cutoffs differ from analyses performed on samples collected up to Month 13; the antibody persistence analysis employed a new version of the assay.
|
Month 36
|
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
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。
一般刊行物
- Iversen OE, Miranda MJ, Ulied A, Soerdal T, Lazarus E, Chokephaibulkit K, Block SL, Skrivanek A, Nur Azurah AG, Fong SM, Dvorak V, Kim KH, Cestero RM, Berkovitch M, Ceyhan M, Ellison MC, Ritter MA, Yuan SS, DiNubile MJ, Saah AJ, Luxembourg A. Immunogenicity of the 9-Valent HPV Vaccine Using 2-Dose Regimens in Girls and Boys vs a 3-Dose Regimen in Women. JAMA. 2016 Dec 13;316(22):2411-2421. doi: 10.1001/jama.2016.17615.
- Bornstein J, Roux S, Kjeld Petersen L, Huang LM, Dobson SR, Pitisuttithum P, Diez-Domingo J, Schilling A, Ariffin H, Tytus R, Rupp R, Senders S, Engel E, Ferris D, Kim YJ, Tae Kim Y, Kurugol Z, Bautista O, Nolan KM, Sankaranarayanan S, Saah A, Luxembourg A. Three-Year Follow-up of 2-Dose Versus 3-Dose HPV Vaccine. Pediatrics. 2021 Jan;147(1):e20194035. doi: 10.1542/peds.2019-4035. Epub 2020 Dec 22.
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 (実際)
2013年12月12日
一次修了 (実際)
2015年6月19日
研究の完了 (実際)
2017年7月24日
試験登録日
最初に提出
2013年11月8日
QC基準を満たした最初の提出物
2013年11月14日
最初の投稿 (見積もり)
2013年11月15日
学習記録の更新
投稿された最後の更新 (実際)
2018年8月8日
QC基準を満たした最後の更新が送信されました
2018年7月12日
最終確認日
2018年7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
- V503-010 (その他の識別子：Merck Protocol Number)
- 2013-001314-15 (EudraCT番号)
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://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
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。