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소아에서의 새로운 폐렴구균 백신 V118C 임상 연구 (V118C-002)

2026년 9월 30일 업데이트: Merck Sharp & Dohme LLC

소아에서 새로운 폐렴구균 백신의 안전성, 내약성 및 면역원성을 평가하기 위한 1상, 무작위, 이중맹검, 능동 대조군 대조 연구

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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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).

연구 유형

중재적

등록 (추정된)

210

단계

  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

2개월 (어린이)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: V118C (Stage 1)

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

IM administration of V118C
실험적: 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.
생물학적: V118C (Stage 2)

IM administration of V118C
활성 비교기: PCV20 (Stage 1)

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

IM administration of PCV20
활성 비교기: 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.
생물학적: PCV20 (Stage 2)

IM administration of PCV20

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Stage 1: Percentage of Participants With Immediate Adverse Events (AEs) Following Vaccination
기간: 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)
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Stage 1: Geometric Mean Concentrations (GMCs) of Serotype-Specific Immunoglobulin G (IgG)
기간: 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]
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Merck Sharp & Dohme LLC

수사관

  • 연구 책임자: Medical Director, Merck Sharp & Dohme LLC

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 1월 13일

기본 완료 (추정된)

2028년 10월 24일

연구 완료 (추정된)

2029년 5월 25일

연구 등록 날짜

최초 제출

2025년 12월 10일

QC 기준을 충족하는 최초 제출

2025년 12월 10일

처음 게시됨 (실제)

2025년 12월 23일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 2일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 30일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • V118C-002

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다