このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

小児における新型肺炎球菌ワクチン V118C の臨床試験 (V118C-002)

2026年9月30日 更新者：Merck Sharp & Dohme LLC

小児を対象とした新規肺炎球菌ワクチンの安全性、忍容性、免疫原性を評価するための第I相、無作為化、二重盲検、活性対照薬対照試験

Researchers are looking for new vaccines to prevent pneumococcal disease, which is any infection in the lungs or other parts of the body that is caused by a type of bacteria called Streptococcus pneumoniae. V118C is a new vaccine designed to help prevent disease from Streptococcus pneumoniae bacteria.

This study will look at V118C in toddlers and infants. The goal of the study is to learn how safe V118C is for children and how well they tolerate it.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

Stage 1 of the study will be conducted in toddlers enrolled at 12 through 15 months of age who previously completed a primary 3-dose infant series with a licensed pneumococcal conjugate vaccine (PCV). Stage 2 will be conducted in infants enrolled at approximately 2 months of age, who will receive the 3+1 schedule (3 infant doses followed by a toddler dose).

研究の種類

介入

入学 (推定)

210

段階

  • フェーズ 1

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • アメリカ
    • California
      • Madera、California、アメリカ、93637
        • 募集
        • Madera Family Medical Group ( Site 1004)
        • コンタクト：
          • Study Coordinator
          • 電話番号：559-673-3000
    • Florida
      • Miami、Florida、アメリカ、33142
        • 募集
        • Acevedo Clinical Research Associates ( Site 1029)
        • コンタクト：
          • Study Coordinator
          • 電話番号：305-649-8871
      • Tampa、Florida、アメリカ、33606
        • 募集
        • University of South Florida-Department of Pediatrics ( Site 1002)
        • コンタクト：
          • Study Coordinator
          • 電話番号：813-821-8039
    • Kansas
      • Topeka、Kansas、アメリカ、66604
        • 募集
        • Cotton O'Neil Research Center ( Site 1039)
        • コンタクト：
          • Study Coordinator
          • 電話番号：785-354-6000
    • Kentucky
      • Louisville、Kentucky、アメリカ、40202
        • 募集
        • University of Louisville, Norton Children's Research Institute ( Site 1005)
        • コンタクト：
          • Study Coordinator
          • 電話番号：502-629-5820
    • Maryland
      • Columbia、Maryland、アメリカ、21045
        • 募集
        • The Pediatric Center ( Site 1025)
        • コンタクト：
          • Study Coordinator
          • 電話番号：443-721-7224
    • Missouri
      • St Louis、Missouri、アメリカ、63104
        • 募集
        • Saint Louis University Center for Vaccine Development ( Site 1031)
        • コンタクト：
          • Study Coordinator
          • 電話番号：314-977-6333
    • New York
      • East Syracuse、New York、アメリカ、13057
        • 募集
        • Child Health Care Associates ( Site 1035)
        • コンタクト：
          • Study Coordinator
          • 電話番号：315-652-8800
    • South Carolina
      • Charleston、South Carolina、アメリカ、29414
        • 募集
        • Carolina Family Care ( Site 1021)
        • コンタクト：
          • Study Coordinator
          • 電話番号：843-870-2225
      • Greenville、South Carolina、アメリカ、29607
        • 募集
        • Tribe Clinical Research, LLC-Pediatrics ( Site 1008)
        • コンタクト：
          • Study Coordinator
          • 電話番号：864-334-0141
      • Spartanburg、South Carolina、アメリカ、29301
        • 募集
        • Tribe Clinical Research - Spartanburg ( Site 1001)
        • コンタクト：
          • Study Coordinator
          • 電話番号：864-334-0141
    • Texas
      • Carrollton、Texas、アメリカ、75006
        • 募集
        • Epic Medical Research - Carrollton ( Site 1038)
        • コンタクト：
          • Study Coordinator
          • 電話番号：972-777-6956
      • Garland、Texas、アメリカ、75043
        • 募集
        • Epic Medical Research- Garland ( Site 1017)
        • コンタクト：
          • Study Coordinator
          • 電話番号：972-777-6956
      • League City、Texas、アメリカ、77573
        • 募集
        • University of Texas Medical Branch ( Site 1020)
        • コンタクト：
          • Study Coordinator
          • 電話番号：832-340-2313
    • Virginia
      • Charlottesville、Virginia、アメリカ、22902
        • 募集
        • Pediatric Research of Charlottesville, LLC ( Site 1012)
        • コンタクト：
          • Study Coordinator
          • 電話番号：434-872-9384

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

2ヶ月～1年 (子)

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:

The main inclusion criteria include but are not limited to the following:

Stage 1:

  • Is previously vaccinated with 3 routine infant doses of Pneumococcal 20-valent conjugate vaccine (PCV20)
  • Is 12 through 15 months of age

Stage 2:

- Is approximately 2 months of age

Both Stages:

  • Was born at full term (gestational age greater than or equal to 37 weeks)

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

Stage 1:

- Has received a PCV dose at 10 months of age and older

Stage 2:

  • Has received prior administration of any pneumococcal vaccine

Both stages:

  • Has a history of invasive pneumococcal disease (IPD)
  • Has a known hypersensitivity to any component of V118C or PCV20 including diphtheria toxoid

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：V118C (Stage 1)

Participants will receive a single 0.5 mL intramuscular (IM) injection of V118C administered at 12 to 15 months of age.
生物学的：V118C (Stage 1)

IM administration of V118C
実験的：V118C (Stage 2)

Participants will receive a single 0.5 mL IM injection of V118C administered at 2,4,6, and 12 months of age.
生物学的：V118C (Stage 2)

IM administration of V118C
アクティブコンパレータ：PCV20 (Stage 1)

Participants will receive a single 0.5 mL IM injection of PCV20 administered at 12 to 15 months of age.
生物学的：PCV20 (Stage 1)

IM administration of PCV20
アクティブコンパレータ：PCV20 (Stage 2)

Participants will receive a single 0.5 mL IM injection of PCV20 administered at 2,4,6, and 12 months of age.
生物学的：PCV20 (Stage 2)

IM administration of PCV20

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
Stage 1: Percentage of Participants With Immediate Adverse Events (AEs) Following Vaccination
時間枠：Up to approximately 30 minutes postvaccination

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants with immediate AEs following vaccination will be reported.
Up to approximately 30 minutes postvaccination
Stage 1: Percentage of Participants With Solicited Injection-Site Adverse Events (AEs)
時間枠：Up to approximately 7 days postvaccination

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A solicited AE is a predefined event that participants legally acceptable representative (LAR) are specifically asked about and record on their electronic vaccine report card (eVRC). Solicited injection-site AEs include redness, swelling, pain or tenderness and hard lump. Percentage of participants with solicited injection-site AEs will be reported.
Up to approximately 7 days postvaccination
Stage 1: Percentage of Participants With Solicited Systemic AEs
時間枠：Up to approximately 7 days postvaccination

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A solicited AE is a predefined event that participants LAR are specifically asked about and record on their eVRC. Solicited systemic AEs include irritability, drowsiness, appetite lost, hives or welts, and fever. Percentage of participants with solicited systemic AEs will be reported.
Up to approximately 7 days postvaccination
Stage 1: Percentage of Participants With Unsolicited Systemic or Injection-Site AEs
時間枠：Up to approximately 28 days postvaccination

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE is an event that is not solicited using a eVRC and that is communicated by a participant. Percentage of participants with unsolicited Systemic or Injection-Site AEs will be reported.
Up to approximately 28 days postvaccination
Stage 1: Percentage of Participants With Serious Adverse Events (SAEs)
時間枠：Up to approximately 12 months postvaccination

A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Percentage of participants with one or more SAEs will be reported.
Up to approximately 12 months postvaccination
Stage 1: Percentage of Participants With Medically Attended AEs (MAAEs)
時間枠：Up to approximately 12 months postvaccination

A MAAE is defined as an adverse event in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency department visit, office visit, or an urgent care visit with any medical personnel for any reason. Percentage of participants with MAAEs will be reported.
Up to approximately 12 months postvaccination
Stage 2: Percentage of Participants With Immediate AEs Following Vaccination
時間枠：Up to approximately 30 minutes after each vaccination

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants with immediate AEs following vaccination will be reported.
Up to approximately 30 minutes after each vaccination
Stage 2: Percentage of Participants With Solicited Injection-Site AEs
時間枠：Up to approximately 7 days after each vaccination

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A solicited AE is a predefined event that participants LAR are specifically asked about and record on their eVRC. Solicited injection-site AEs include redness, swelling, pain or tenderness and hard lump. Percentage of participants with solicited injection-site AEs will be reported.
Up to approximately 7 days after each vaccination
Stage 2: Percentage of Participants With Solicited Systemic AEs
時間枠：Up to approximately 7 days after each vaccination

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A solicited AE is a predefined event that participants LAR are specifically asked about and record on their eVRC. Solicited systemic AEs include irritability, drowsiness, appetite lost, hives or welts, and fever. Percentage of participants with solicited systemic AEs will be recorded.
Up to approximately 7 days after each vaccination
Stage 2: Percentage of Participants With Unsolicited Systemic or Injection-Site AEs
時間枠：Up to approximately 28 days after each vaccination

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE is an event that is not solicited using a eVRC and that is communicated by a participant. Percentage of participants with unsolicited Systemic or Injection-Site AEs will be reported.
Up to approximately 28 days after each vaccination
Stage 2: Percentage of Participants With SAEs
時間枠：Up to approximately 12 months postdose 4

A SAE is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Percentage of participants with one or more SAEs will be reported.
Up to approximately 12 months postdose 4
Stage 2: Percentage of Participants With MAAEs
時間枠：Up to approximately 12 months postdose 4

A MAAE is defined as an adverse event in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency department visit, office visit, or an urgent care visit with any medical personnel for any reason. Percentage of participants with MAAEs will be reported.
Up to approximately 12 months postdose 4

二次結果の測定

結果測定
メジャーの説明
時間枠
Stage 1: Geometric Mean Concentrations (GMCs) of Serotype-Specific Immunoglobulin G (IgG)
時間枠：Up to approximately 30 days post vaccination

The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (Pn ECL) assay. GMCs of Serotype-specific IgG at 30 days postvaccination with V118C and PCV20 will be reported.
Up to approximately 30 days post vaccination
Stage 1: Ratio of GMCs of Serotype-Specific IgG of V118C to PCV20 [V118C/PCV20]
時間枠：Approximately Day 30 postvaccination

The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (Pn ECL) assay. Ratio of GMCs of serotype-specific IgG of V118C to PCV20 will be reported.
Approximately Day 30 postvaccination
Stage 1: Geometric Mean Fold Rises (GMFRs) of Serotype-Specific Immunoglobulin G (IgG)
時間枠：Day 1 (Baseline) and approximately Day 30 postvaccination

Geometric mean fold rise (GMFR) is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline. GMFRs of serotype-specific IgG from baseline (Day 1) to Day 30 with V118C and PCV20 for IgG responses will be reported.
Day 1 (Baseline) and approximately Day 30 postvaccination
Stage 1: Percentage of Participants With a ≥ 4-fold Rise for Serotype Specific IgG Concentrations
時間枠：Day 1 (Baseline) and approximately Day 30 postvaccination

The percentage of participants with ≥4-fold rise from baseline (Day 1) to Day 30 with V118C and PCV20 for IgG responses will be reported.
Day 1 (Baseline) and approximately Day 30 postvaccination
Stage 2: Percentage of Participants With IgG ≥0.35 μg/mL (Response Rates) for Serotype Specific IgG Concentrations at 30 Days Postdose 3
時間枠：Up to approximately 30 days postdose 3

Percentage of participants with IgG ≥0.35 μg/mL (response rates) for each serotype at 30 days postdose 3 (PD3) with V118C and PCV20 will be reported will be reported.
Up to approximately 30 days postdose 3
Stage 2: Percentage of Participants With IgG ≥0.35 μg/mL (Response Rates) for Serotype Specific IgG Concentrations at 30 Days Predose 4
時間枠：Up to approximately 6 months post dose 3

Percentage of participants with IgG ≥0.35 μg/mL (response rates) for each serotype at predose 4 (PD4) with V118C and PCV20 will be reported.
Up to approximately 6 months post dose 3
Stage 2: Percentage of Participants With IgG ≥0.35 μg/mL (Response Rates) for Serotype Specific IgG Concentrations at 30 Days Postdose 4
時間枠：Up to approximately 30 days postdose 4

Percentage of participants with IgG ≥0.35 μg/mL (response rates) for each serotype at 30 days postdose 4 with V118C and PCV20 will be reported.
Up to approximately 30 days postdose 4
Stage 2: Difference in the Response Rates [V118C minus PCV20] for Each Serotype at 30 Days Postdose 3
時間枠：Up to approximately 30 days postdose 3

Difference in the response rates [V118C minus PCV20] for each serotype at 30 days postdose 3 with V118C and PCV20 will be reported.
Up to approximately 30 days postdose 3
Stage 2: Difference in the Response Rates [V118C Minus PCV20] for Each Serotype at 30 Days Postdose 4
時間枠：Up to approximately 30 days postdose 4

Difference in the response rates [V118C minus PCV20] for each serotype at 30 days postdose 4 with V118C and PCV20 will be reported.
Up to approximately 30 days postdose 4
Stage 2: GMCs of Serotype-Specific IgG at 30 Days Postdose 3
時間枠：Up to approximately 30 days postdose 3

The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (Pn ECL) assay. GMCs of serotype-specific IgG at 30 days postdose 3 with V118C and PCV20 will be reported.
Up to approximately 30 days postdose 3
Stage 2: GMCs of Serotype-Specific IgG at 30 Days Predose 4
時間枠：Up to approximately 6 months post dose 3

The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (Pn ECL) assay. Serotype-specific IgG GMCs at 30 days predose 4 with V118C and PCV20 will be reported.
Up to approximately 6 months post dose 3
Stage 2: GMCs of Serotype-Specific IgG at 30 Days Postdose 4
時間枠：Up to approximately 30 days postdose 4

The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (Pn ECL) assay. Serotype-specific IgG GMCs at 30 days postdose 4 with V118C and PCV20 will be reported.
Up to approximately 30 days postdose 4
Stage 2: Ratio of Serotype-Specific IgG GMCs of V118C to PCV20 [V118C/PCV20] at 30 Days Postdose 3
時間枠：Up to approximately 30 days postdose 3

The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (Pn ECL) assay. Ratio of serotype-specific IgG GMCs of V118C to PCV20 [V118C/PCV20] at 30 days postdose 3 will be reported.
Up to approximately 30 days postdose 3
Stage 2: Ratio of Serotype-Specific IgG GMCs of V118C to PCV20 [V118C/PCV20] at 30 Days Postdose 4
時間枠：Up to approximately 30 days postdose 4

The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (Pn ECL) assay. Ratio of serotype-specific IgG GMCs of V118C to PCV20 [V118C/PCV20] at 30 days postdose 4 will be reported.
Up to approximately 30 days postdose 4

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

Merck Sharp & Dohme LLC

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。

便利なリンク

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)

2026年1月13日

一次修了 (推定)

2028年10月24日

研究の完了 (推定)

2029年5月25日

試験登録日

最初に提出

2025年12月10日

QC基準を満たした最初の提出物

2025年12月10日

最初の投稿 (実際)

2025年12月23日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月2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30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

  • V118C-002

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

はい

米国FDA規制機器製品の研究

いいえ

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。

購読する