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

27. august 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

1200

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35233
        • Rekruttering
        • UAB Child Health Research Unit (CHRU)
      • Birmingham, Alabama, Forente stater, 35205
        • Rekruttering
        • Alabama Clinical Therapeutics, LLC Birmingham Pediatric Associates
      • Guntersville, Alabama, Forente stater, 35976
        • Rekruttering
        • Lakeview Clinical Research, LLC
    • California
      • Fair Oaks, California, Forente stater, 95628
        • Rekruttering
        • Apex Research Group
      • Ontario, California, Forente stater, 91762
        • Rekruttering
        • Orange County Research Institute
    • Colorado
      • Aurora, Colorado, Forente stater, 80045
        • Rekruttering
        • Children's Hospital Colorado
    • Florida
      • Miami Lakes, Florida, Forente stater, 33016
        • Rekruttering
        • Indago Research & Health Center, Inc
      • Miami Lakes, Florida, Forente stater, 33014
        • Rekruttering
        • Riveldi and Associates
      • Tampa, Florida, Forente stater, 33617
        • Har ikke rekruttert ennå
        • Children's Health Center
    • Idaho
      • Ammon, Idaho, Forente stater, 83406
        • Rekruttering
        • Medical Research Partners
      • Blackfoot, Idaho, Forente stater, 83221
        • Rekruttering
        • Bingham Memorial Hospital
      • Boise, Idaho, Forente stater, 83702
        • Rekruttering
        • ASR, LLC
    • Kentucky
      • Bardstown, Kentucky, Forente stater, 40004
        • Rekruttering
        • Kentucky Pediatric/ Adult Research
    • Louisiana
      • Covington, Louisiana, Forente stater, 70433
        • Rekruttering
        • Avacare
      • Lafayette, Louisiana, Forente stater, 70508
        • Rekruttering
        • Velocity Clinical Research, Lafayette
      • Shreveport, Louisiana, Forente stater, 71101
        • Rekruttering
        • LSU Health Shreveport Clinical Trials Office
      • Shreveport, Louisiana, Forente stater, 71101
        • Rekruttering
        • Ochsner/LSU Health Shreveport - Progressive Pediatrics
      • Shreveport, Louisiana, Forente stater, 71103
        • Rekruttering
        • Ochsner LSU Health Shreveport Ambulatory Care Center
      • Shreveport, Louisiana, Forente stater, 71103
        • Rekruttering
        • Ochsner/LSU Health Shreveport Academic Medical Center
    • Massachusetts
      • Fall River, Massachusetts, Forente stater, 02721
        • Rekruttering
        • Pediatric Associates of Fall River
    • Michigan
      • Bingham Farms, Michigan, Forente stater, 48025
        • Rekruttering
        • Michigan Center of Medical Research
    • Minnesota
      • Minneapolis, Minnesota, Forente stater, 55402
        • Rekruttering
        • Clinical Research Institute, Inc.
    • Nebraska
      • Lincoln, Nebraska, Forente stater, 68504
        • Rekruttering
        • Midwest Children's Health Research Institute
      • Lincoln, Nebraska, Forente stater, 68505
        • Rekruttering
        • Midwest Children's Health Research Institute
      • Lincoln, Nebraska, Forente stater, 68516
        • Rekruttering
        • Midwest Children's Health Research Institute
      • Lincoln, Nebraska, Forente stater, 68522
        • Rekruttering
        • Midwest Children's Health Research Institute
    • New York
      • East Syracuse, New York, Forente stater, 13057
        • Rekruttering
        • Child Health Care Associates
      • Horseheads, New York, Forente stater, 14845
        • Rekruttering
        • Corning Center for Clinical Research
      • Rochester, New York, Forente stater, 14642
        • Rekruttering
        • University of Rochester Medical Center
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45245
        • Rekruttering
        • Pediatric Associates of Mt. Carmel
      • Cincinnati, Ohio, Forente stater, 45206
        • Rekruttering
        • Cincinnati Children's Hospital Medical Center Investigational Drug Services
      • Cincinnati, Ohio, Forente stater, 45206
        • Rekruttering
        • Cincinnati Children's Hospital Medical Center Vaccine Research Center
      • Dayton, Ohio, Forente stater, 45409
        • Rekruttering
        • Dayton Clinical Research
      • South Euclid, Ohio, Forente stater, 44121
        • Rekruttering
        • Senders Pediatrics
    • South Carolina
      • Simpsonville, South Carolina, Forente stater, 29681
        • Rekruttering
        • Tribe Clinical Research LLC. at Parkside Pediatrics Five Forks
    • Tennessee
      • Tullahoma, Tennessee, Forente stater, 37388
        • Rekruttering
        • Pediatric Clinical Trials of Tennessee, LLC
    • Texas
      • Corpus Christi, Texas, Forente stater, 78411
        • Rekruttering
        • Driscoll Children's Hosptial
      • Houston, Texas, Forente stater, 77065
        • Rekruttering
        • Kool Kids Pediatrics
      • Houston, Texas, Forente stater, 77054
        • Rekruttering
        • Mercury Clinical Research (Administrative Office)
      • Houston, Texas, Forente stater, 77077
        • Rekruttering
        • Mercury Clinical Research - Sunrise Pediatrics
      • Houston, Texas, Forente stater, 77402
        • Rekruttering
        • Neutra Life Sciences
      • Houston, Texas, Forente stater, 77054
        • Rekruttering
        • Mercury Clinical Research - Administrative Office
      • Houston, Texas, Forente stater, 77074
        • Har ikke rekruttert ennå
        • RTX Clinical Research
      • Houston, Texas, Forente stater, 77087
        • Rekruttering
        • Mercury Clinical Research - MD Kids Pediatrics
      • League City, Texas, Forente stater, 77573
        • Rekruttering
        • University of Texas Medical Branch,
      • Lewisville, Texas, Forente stater, 75067
        • Har ikke rekruttert ennå
        • Prime Clinical Research Inc.
      • Mansfield, Texas, Forente stater, 76063
        • Har ikke rekruttert ennå
        • Prime Clinical Research Inc.
      • Richmond, Texas, Forente stater, 77469
        • Rekruttering
        • Pediatric Center- Neutra Life Sciences
      • San Antonio, Texas, Forente stater, 78215
        • Rekruttering
        • Sun Research Institute
      • Victoria, Texas, Forente stater, 77901
        • Rekruttering
        • Victoria Clinical Research Group
    • Utah
      • Layton, Utah, Forente stater, 84041
        • Rekruttering
        • Tanner Clinic
      • Layton, Utah, Forente stater, 84041
        • Rekruttering
        • Tanner Clinic - Layton Parkway
      • Provo, Utah, Forente stater, 84604
        • Rekruttering
        • AMR Clinical
      • Syracuse, Utah, Forente stater, 84075
        • Rekruttering
        • AMR Clinical
      • West Jordan, Utah, Forente stater, 84088
        • Rekruttering
        • Velocity Clinical Research, Salt Lake City
    • Virginia
      • Charlottesville, Virginia, Forente stater, 22902
        • Rekruttering
        • Pediatric Research of Charlottesville, LLC
      • Richmond, Virginia, Forente stater, 23226
        • Rekruttering
        • Clinical Research Partners, LLC
  • Puerto Rico
      • Caguas, Puerto Rico, 00725
        • Rekruttering
        • Caguas Clinical Research LLC
      • Ponce, Puerto Rico, 00716
        • Rekruttering
        • Ponce Medical School Foundation Inc. / CAIMED Center
      • San Juan, Puerto Rico, 00907-1509
        • Rekruttering
        • BRCR Global Puerto Rico
      • San Juan, Puerto Rico, 00918
        • Rekruttering
        • CMRC Headlands, LLC

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn

Tar imot friske 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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)
20-valent pneumococcal conjugate vaccine (20vPnC)
Biologisk: 20-valent pneumokokkkonjugatvaksine (20vPnC)
20-valent pneumokokkkonjugatvaksine (20vPnC)
Andre navn:
  • Prevnar 20
Eksperimentell: PG4 (intramuscular)
Multivalent Pneumococcal vaccine
Biologisk: PG4
Multivalent Pneumococcal Vaccine

Hva måler studien?

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Pfizer

Etterforskere

  • Studieleder: Pfizer CT.gov Call Center, Pfizer

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

15. juni 2026

Primær fullføring (Antatt)

2. desember 2027

Studiet fullført (Antatt)

2. desember 2027

Datoer for studieregistrering

Først innsendt

15. juni 2026

Først innsendt som oppfylte QC-kriteriene

15. juni 2026

Først lagt ut (Faktiske)

22. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

31. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • C4931004
  • 2025 (U.S. NIH-stipend/kontrakt: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-523445-10-00 (Registeridentifikator: CTIS (EU))

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Ja

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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