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Klinická studie nové pneumokokové vakcíny V118C u dětí (V118C-002)

30. září 2026 aktualizováno: Merck Sharp & Dohme LLC

Fáze 1, randomizovaná, dvojitě zaslepená, aktivně komparátorem kontrolovaná studie hodnotící bezpečnost, snášenlivost a imunogenitu nové pneumokokové vakcíny u dětí

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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

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).

Typ studie

Intervenční

Zápis (Odhadovaný)

210

Fáze

  • Fáze 1

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

2 měsíce až 1 rok (Dítě)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: V118C (Stage 1)

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

IM administration of V118C
Experimentální: 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.
Biologický: V118C (Stage 2)

IM administration of V118C
Aktivní komparátor: PCV20 (Stage 1)

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

IM administration of PCV20
Aktivní komparátor: 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.
Biologický: PCV20 (Stage 2)

IM administration of PCV20

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Stage 1: Percentage of Participants With Immediate Adverse Events (AEs) Following Vaccination
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Stage 1: Geometric Mean Concentrations (GMCs) of Serotype-Specific Immunoglobulin G (IgG)
Časové okno: 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]
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Merck Sharp & Dohme LLC

Vyšetřovatelé

  • Ředitel studie: Medical Director, Merck Sharp & Dohme LLC

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

13. ledna 2026

Primární dokončení (Odhadovaný)

24. října 2028

Dokončení studie (Odhadovaný)

25. května 2029

Termíny zápisu do studia

První předloženo

10. prosince 2025

První předloženo, které splnilo kritéria kontroly kvality

10. prosince 2025

První zveřejněno (Aktuální)

23. prosince 2025

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

2. října 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

30. září 2026

Naposledy ověřeno

1. září 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • V118C-002

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

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

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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