Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Eine klinische Studie zum neuartigen Pneumokokken-Impfstoff V118C bei Kindern (V118C-002)

30. September 2026 aktualisiert von: Merck Sharp & Dohme LLC

Eine randomisierte, doppelblinde, aktiv-kontrollierte Phase-1-Studie zur Bewertung der Sicherheit, Verträglichkeit und Immunogenität eines neuartigen Pneumokokken-Impfstoffs bei Kindern

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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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).

Studientyp

Interventionell

Einschreibung (Geschätzt)

210

Phase

  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

2 Monate bis 1 Jahr (Kind)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: V118C (Stage 1)

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

IM administration of V118C
Experimental: 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.
Biologisch: V118C (Stage 2)

IM administration of V118C
Aktiver Komparator: PCV20 (Stage 1)

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

IM administration of PCV20
Aktiver Komparator: 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.
Biologisch: PCV20 (Stage 2)

IM administration of PCV20

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Stage 1: Percentage of Participants With Immediate Adverse Events (AEs) Following Vaccination
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Stage 1: Geometric Mean Concentrations (GMCs) of Serotype-Specific Immunoglobulin G (IgG)
Zeitfenster: 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]
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Merck Sharp & Dohme LLC

Ermittler

  • Studienleiter: Medical Director, Merck Sharp & Dohme LLC

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

13. Januar 2026

Primärer Abschluss (Geschätzt)

24. Oktober 2028

Studienabschluss (Geschätzt)

25. Mai 2029

Studienanmeldedaten

Zuerst eingereicht

10. Dezember 2025

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

10. Dezember 2025

Zuerst gepostet (Tatsächlich)

23. Dezember 2025

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

2. Oktober 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

30. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • V118C-002

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren