Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Study to Learn About Safety, Tolerability, and Immune Response of a Catch-up Pneumococcal Vaccine in Children and Adolescents

7. juli 2026 opdateret af: Pfizer

A PHASE 3, RANDOMIZED DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A CATCH-UP VACCINATION REGIMEN OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY CHILDREN AND ADOLESCENTS

The purpose of this study is to learn about the safety of a new pneumococcal vaccine and how the new pneumococcal vaccine helps to fight against germs that can cause pneumonia (lung infections), meningitis (brain infections), and otitis media (ear infections) in children when compared to the pneumococcal vaccine that is currently in use, 20vPnC (Prevnar 20®).

This study will test if the new pneumococcal vaccine is as safe as the one that is currently in use. It will also assess how the new vaccine works in comparison to the one that is currently in use. To measure how the new pneumococcal vaccine compares to the current one, blood samples will be used to measure the body's ability to create proteins to fight those germs. This new vaccine can possibly provide additional protection against germs that cause pneumococcal disease that are not included in the vaccines that are currently given to children. Pneumococcal disease includes a variety of infections caused by a specific germ, Streptococcus pneumoniae

This study is seeking participants who:

  • Are children aged 15 months to 18 years.
  • May or may not have received any doses of pneumococcal conjugate vaccine (PCV) in the past.

The study will be conducted in the United States, Puerto Rico, and other countries.

Participants will be assigned to 1 of 3 groups based on age:

Group 1: 15 months to less than 2 years (about 300 participants) Group 2: 2 years to less than 5 years (about 300 participants) Group 3: 5 years to less than 18 years (about 600 participants)

Within each group, participants will be assigned by chance in a 2:1 ratio to receive 1 vaccine injection (shot) with either PG4 (new vaccine) or 20vPnC, given in the arm or thigh. This means that for every 3 participants, about 2 will receive PG4 and about 1 will receive 20vPnC.

Each participant will take part in the study for approximately 6 months. During this time, each participant will visit a clinic 2 times (visit 1 for vaccination and visit 2 to follow up) and will be contacted via telephone once (for a 6 month follow up).

At the study clinic visits, participants will have their blood drawn and be asked if they have experienced any side effects. A side effect is an unintentional or unexpected reaction to a vaccine. During the 6-month follow-up contact, participants will be asked about any further side effects.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

1200

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35205
        • Rekruttering
        • Alabama Clinical Therapeutics, LLC Birmingham Pediatric Associates
    • California
      • Fair Oaks, California, Forenede Stater, 95628
        • Rekruttering
        • Apex Research Group
      • Ontario, California, Forenede Stater, 91762
        • Rekruttering
        • Orange County Research Institute
    • Florida
      • Miami Lakes, Florida, Forenede Stater, 33014
        • Ikke rekrutterer endnu
        • Riveldi and Associates
      • Miami Lakes, Florida, Forenede Stater, 33016
        • Rekruttering
        • Indago Research & Health Center, Inc
    • Idaho
      • Ammon, Idaho, Forenede Stater, 83406
        • Ikke rekrutterer endnu
        • Medical Research Partners
      • Blackfoot, Idaho, Forenede Stater, 83221
        • Rekruttering
        • Bingham Memorial Hospital
      • Boise, Idaho, Forenede Stater, 83702
        • Rekruttering
        • ASR, LLC
    • Kentucky
      • Bardstown, Kentucky, Forenede Stater, 40004
        • Rekruttering
        • Kentucky Pediatric/ Adult Research
    • Louisiana
      • Covington, Louisiana, Forenede Stater, 70433
        • Ikke rekrutterer endnu
        • Avacare
      • Lafayette, Louisiana, Forenede Stater, 70508
        • Rekruttering
        • Velocity Clinical Research, Lafayette
      • Shreveport, Louisiana, Forenede Stater, 71101
        • Rekruttering
        • LSU Health Shreveport Clinical Trials Office
      • Shreveport, Louisiana, Forenede Stater, 71101
        • Rekruttering
        • Ochsner/LSU Health Shreveport - Progressive Pediatrics
      • Shreveport, Louisiana, Forenede Stater, 71103
        • Rekruttering
        • Ochsner LSU Health Shreveport Ambulatory Care Center
      • Shreveport, Louisiana, Forenede Stater, 71103
        • Rekruttering
        • Ochsner/LSU Health Shreveport Academic Medical Center
    • Massachusetts
      • Fall River, Massachusetts, Forenede Stater, 02721
        • Rekruttering
        • Pediatric Associates of Fall River
    • Michigan
      • Bingham Farms, Michigan, Forenede Stater, 48025
        • Rekruttering
        • Michigan Center of Medical Research
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55402
        • Rekruttering
        • Clinical Research Institute, Inc.
    • Nebraska
      • Lincoln, Nebraska, Forenede Stater, 68504
        • Rekruttering
        • Midwest Children's Health Research Institute
      • Lincoln, Nebraska, Forenede Stater, 68505
        • Rekruttering
        • Midwest Children's Health Research Institute
      • Lincoln, Nebraska, Forenede Stater, 68516
        • Rekruttering
        • Midwest Children's Health Research Institute
      • Lincoln, Nebraska, Forenede Stater, 68522
        • Rekruttering
        • Midwest Children's Health Research Institute
    • New York
      • East Syracuse, New York, Forenede Stater, 13057
        • Ikke rekrutterer endnu
        • Child Health Care Associates
      • Horseheads, New York, Forenede Stater, 14845
        • Rekruttering
        • Corning Center for Clinical Research
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45245
        • Ikke rekrutterer endnu
        • Pediatric Associates of Mt. Carmel
      • Dayton, Ohio, Forenede Stater, 45409
        • Rekruttering
        • Dayton Clinical Research
      • South Euclid, Ohio, Forenede Stater, 44121
        • Rekruttering
        • Senders Pediatrics
    • South Carolina
      • Simpsonville, South Carolina, Forenede Stater, 29681
        • Rekruttering
        • Tribe Clinical Research LLC. at Parkside Pediatrics Five Forks
    • Tennessee
      • Tullahoma, Tennessee, Forenede Stater, 37388
        • Ikke rekrutterer endnu
        • Pediatric Clinical Trials of Tennessee, LLC
    • Texas
      • Houston, Texas, Forenede Stater, 77065
        • Ikke rekrutterer endnu
        • Kool Kids Pediatrics
      • Houston, Texas, Forenede Stater, 77087
        • Rekruttering
        • Mercury Clinical Research - Pediatric Associates
      • Houston, Texas, Forenede Stater, 77054
        • Rekruttering
        • Mercury Clinical Research (Administrative Office)
      • Houston, Texas, Forenede Stater, 77402
        • Rekruttering
        • Neutra Life Sciences
      • Richmond, Texas, Forenede Stater, 77469
        • Rekruttering
        • Pediatric Center- Neutra Life Sciences
      • San Antonio, Texas, Forenede Stater, 78215
        • Rekruttering
        • Sun Research Institute
      • Victoria, Texas, Forenede Stater, 77901
        • Rekruttering
        • Victoria Clinical Research Group
    • Utah
      • Layton, Utah, Forenede Stater, 84041
        • Rekruttering
        • Tanner Clinic
      • Layton, Utah, Forenede Stater, 84041
        • Rekruttering
        • Tanner Clinic - Layton Parkway
      • Provo, Utah, Forenede Stater, 84604
        • Rekruttering
        • AMR Clinical
      • Syracuse, Utah, Forenede Stater, 84075
        • Rekruttering
        • AMR Clinical
      • West Jordan, Utah, Forenede Stater, 84088
        • Rekruttering
        • Velocity Clinical Research, Salt Lake City
    • Virginia
      • Charlottesville, Virginia, Forenede Stater, 22902
        • Rekruttering
        • Pediatric Research of Charlottesville, LLC
      • Richmond, Virginia, Forenede Stater, 23226
        • Rekruttering
        • Clinical Research Partners, LLC
  • Puerto Rico
      • San Juan, Puerto Rico, 00907-1509
        • Rekruttering
        • BRCR Global Puerto Rico

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

Cohort 1 (Participants ≥15 Months to <2 Years of Age) Healthy toddlers and children ≥15 months to <2 years of age with documentation of prior receipt of PCV.

Cohort 2 (Participants ≥2 Years to <5 Years of Age) Healthy toddlers and children ≥2 years to <5 years of age with documentation of prior receipt of PCV if applicable.

Cohort 3 (Participants ≥5 Years to <18 Years of Age) Healthy children ≥5 years to <18 years of age with documentation of prior receipt of PCV (if applicable). A negative urine pregnancy test is required for individuals of childbearing potential (IOCBP). IOCBP or participants able to father must also agree to use a highly effective method of birth control.

Exclusion Criteria:

All Cohorts (Participants ≥15 Months to <18 Years of Age)

Children with significant medical, psychiatric, or neurological conditions (eg, immunodeficiency or history of seizure); or a history of confirmed invasive pneumococcal infection in the past will be excluded from enrolment in the trial

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)
20-valent pneumococcal conjugate vaccine (20vPnC)
Biologisk: 20-valent pneumokokkonjugatvaccine (20vPnC)
20-valent pneumokokkonjugatvaccine (20vPnC)
Andre navne:
  • Prevnar 20
Eksperimentel: PG4 (intramuscular)
Multivalent Pneumococcal vaccine
Biologisk: PG4
Multivalent Pneumococcal Vaccine

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Tidsramme: Within 7 days after Vaccination
Within 7 days after Vaccination
Percentage of Participants With Systemic Events Within 7 Days after Vaccination
Tidsramme: Within 7 days after Vaccination
Within 7 days after Vaccination
Percentage of Participants With Adverse Events (AEs)
Tidsramme: From Vaccination to 1 month after Vaccination
From Vaccination to 1 month after Vaccination
Percentage of Participants With Serious Adverse Events (SAEs)
Tidsramme: From Vaccination to 6 months after Vaccination
From Vaccination to 6 months after Vaccination
GMCs of serotype-specific IgG concentrations
Tidsramme: 1 month after vaccination
1 month after vaccination
GMTs of serotype-specific OPA titers
Tidsramme: 1 month after vaccination
1 month after vaccination

Sekundære resultatmål

Resultatmål
Tidsramme
Percentage of participants with predefined serotype-specific IgG concentrations
Tidsramme: 1 month after vaccination
1 month after vaccination
IgG GMFRs
Tidsramme: 1 month after vaccination
1 month after vaccination
Percentage of participants with a ≥4-fold rise in serotype-specific OPA titers
Tidsramme: before to 1 month after vaccination
before to 1 month after vaccination
OPA GMFRs
Tidsramme: before to 1 month after vaccination
before to 1 month after vaccination

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pfizer

Efterforskere

  • Studieleder: Pfizer CT.gov Call Center, Pfizer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. juni 2026

Primær færdiggørelse (Anslået)

2. december 2027

Studieafslutning (Anslået)

2. december 2027

Datoer for studieregistrering

Først indsendt

15. juni 2026

Først indsendt, der opfyldte QC-kriterier

15. juni 2026

Først opslået (Faktiske)

22. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • C4931004
  • 2025-523445-10-00 (Registry Identifier: CTIS (EU))

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med 20-valent pneumokokkonjugatvaccine (20vPnC)

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Brazil

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner