A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
11. september 2026 opdateret af: Pfizer
A PHASE 3, RANDOMIZED, DOUBLE-BLINDED TRIAL TO EVALUATE THE SAFETY AND TOLERABILITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS
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 infants 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. 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 infants. Pneumococcal disease includes a variety of infections caused by a specific germ, Streptococcus pneumoniae.
There are two groups in this study. All participants will be assigned to one of the two groups. This study is seeking participants who are:
- infants who are about 2 months of age
About 2400 infants will be assigned by chance to one of the two groups to receive either PG4 (new vaccine) or 20vPnC (currently in use) into the left thigh muscle at 2, 4, 6, and 12 to 15 months of age.
Infants will take part in this study for about 16 to 19 months (about 1 and a half years). During this time, infants will have 6 study clinic visits and 1 phone call. At these study clinic visits, parent(s)/legal guardian(s) will be asked if the infant experienced any side effects. A side effect is an unintentional or unexpected reaction to a vaccine.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
2400
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Pfizer CT.gov Call Center
- Telefonnummer: 1-800-718-1021
- E-mail: ClinicalTrials.gov_Inquiries@pfizer.com
Studiesteder
-
-
New South Wales
-
Westmead, New South Wales, Australien, 2145
- Ikke rekrutterer endnu
- The Children's Hospital at Westmead
-
-
Queensland
-
Brisbane, Queensland, Australien, 4101
- Ikke rekrutterer endnu
- Queensland Children's Hospital
-
South Brisbane, Queensland, Australien, 4101
- Ikke rekrutterer endnu
- Centre for Children's Health Research
-
-
Victoria
-
Clayton, Victoria, Australien, 3168
- Ikke rekrutterer endnu
- Monash Health
-
Parkville, Victoria, Australien, 3052
- Rekruttering
- Murdoch Children's Research Institute
-
-
Western Australia
-
Nedlands, Western Australia, Australien, 6009
- Rekruttering
- Perth Children's Hospital
-
Nedlands, Western Australia, Australien, 6009
- Rekruttering
- The Kids Research Institute Australia
-
-
-
-
Ontario
-
London, Ontario, Canada, N5W 6A2
- Rekruttering
- Milestone Research Inc.
-
Sarnia, Ontario, Canada, N7T 4X3
- Rekruttering
- Bluewater Clinical Research Group Inc.
-
-
-
-
Keski-Pohjanmaa
-
Kokkola, Keski-Pohjanmaa, Finland, 67100
- Ikke rekrutterer endnu
- FVR, Kokkolan rokotetutkimusklinikka
-
-
North Ostrobothnia
-
Oulu, North Ostrobothnia, Finland, 90220
- Ikke rekrutterer endnu
- FVR, Oulun rokotetutkimusklinikka
-
-
Pirkanmaa
-
Tampere, Pirkanmaa, Finland, 33100
- Ikke rekrutterer endnu
- FVR, Tampereen rokotetutkimusklinikka
-
-
Uusimaa
-
Espoo, Uusimaa, Finland, 02230
- Ikke rekrutterer endnu
- FVR, Espoon rokotetutkimusklinikka
-
Helsinki, Uusimaa, Finland, 00290
- Ikke rekrutterer endnu
- MeVac - Meilahti Vaccine Research Center
-
Helsinki, Uusimaa, Finland, 00100
- Ikke rekrutterer endnu
- FVR, Etelä-Helsingin rokotetutkimusklinikka
-
Jarvenpaa, Uusimaa, Finland, 04400
- Ikke rekrutterer endnu
- FVR, Järvenpään rokotetutkimusklinikka
-
-
-
-
Florida
-
Estero, Florida, Forenede Stater, 33928
- Rekruttering
- Starz Pediatrics
-
Fort Lauderdale, Florida, Forenede Stater, 33304
- Rekruttering
- Innovate Research Centers, LLC
-
Fort Myers, Florida, Forenede Stater, 33908
- Rekruttering
- MacKoul Pediatrics Fort Myers
-
Miami, Florida, Forenede Stater, 33135
- Ikke rekrutterer endnu
- Dr. Gala, LLC
-
-
Georgia
-
Union City, Georgia, Forenede Stater, 30291
- Rekruttering
- Rophe Adult and Pediatric Medicine/SKYCRNG
-
-
Idaho
-
Idaho Falls, Idaho, Forenede Stater, 83404
- Rekruttering
- Rosemark Women Care Specialists
-
-
Illinois
-
Chicago, Illinois, Forenede Stater, 60621
- Rekruttering
- Eagle Clinical Research
-
-
Kentucky
-
Bardstown, Kentucky, Forenede Stater, 40004
- Rekruttering
- Kentucky Pediatric/ Adult Research
-
-
Louisiana
-
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
-
-
New York
-
Hawthorne, New York, Forenede Stater, 10532
- Rekruttering
- Boston Children's Health Physicians
-
Valhalla, New York, Forenede Stater, 10595
- Rekruttering
- Maria Fareri Children's Hospital
-
-
Ohio
-
South Euclid, Ohio, Forenede Stater, 44121
- Rekruttering
- Senders Pediatrics
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Forenede Stater, 73103
- Rekruttering
- Legacy Clinical Trials
-
-
Oregon
-
Gresham, Oregon, Forenede Stater, 97030
- Rekruttering
- Cyn3rgy Research Corporation
-
-
Pennsylvania
-
Sayre, Pennsylvania, Forenede Stater, 18840
- Rekruttering
- Donald Guthrie Foundation
-
Sayre, Pennsylvania, Forenede Stater, 18840
- Rekruttering
- Guthrie Medical Group
-
-
South Carolina
-
Simpsonville, South Carolina, Forenede Stater, 29680
- Rekruttering
- Tribe Clinical Research LLC. at Parkside Pediatrics Five Forks
-
-
Texas
-
Plano, Texas, Forenede Stater, 75093
- Ikke rekrutterer endnu
- National Research Centers, Plano LLC
-
-
Virginia
-
Gordonsville, Virginia, Forenede Stater, 22942
- Rekruttering
- Pediatric Research of Charlottesville, LLC.
-
-
-
-
-
Dziekanów Leśny, Polen, 05-092
- Ikke rekrutterer endnu
- SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym
-
-
-
-
Bavaria
-
Schönau am Königssee, Bavaria, Tyskland, 83471
- Ikke rekrutterer endnu
- Kinder- und Jugendarztpraxis Dr. med. Michael Horn
-
-
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:
- Infants who are about 2 months of age
- Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
Exclusion Criteria:
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis).
- Major known congenital malformation or serious chronic disorder.
- Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
- Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
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: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: PG4 (intramuscular)
Multivalent Pneumococcal Vaccine
|
Multivalent Pneumococcal Vaccine
|
|
Aktiv komparator: 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)
20-valent pneumococcal conjugate vaccine (20vPnC)
|
20-valent pneumokokkonjugatvaccine (20vPnC)
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Procentdel af deltagere, der rapporterede lokale reaktioner inden for 7 dage efter hver dosis
Tidsramme: Dag 7
|
Fremkaldte lokale reaktioner efter hver dosis
|
Dag 7
|
|
Procentdel af deltagere, der rapporterer alvorlige bivirkninger (SAE)
Tidsramme: Dosis 1 til 6 måneder efter dosis 4
|
SAE, der forekommer fra dosis 1 til 6 måneder efter dosis 4
|
Dosis 1 til 6 måneder efter dosis 4
|
|
Percentage of participants reporting systemic events within 7 days after each dose
Tidsramme: Day 7
|
Prompted systemic events after each dose
|
Day 7
|
|
Percentage of participants reporting adverse events (AEs) from Dose 1 to 1 month after Dose 3
Tidsramme: Dose 1 to 1 month after Dose 3
|
AEs occurring from Dose 1 to 1 month after Dose 3
|
Dose 1 to 1 month after Dose 3
|
|
Percentage of participants reporting AEs from Dose 4 to 1 month after Dose 4
Tidsramme: Dose 4 to 1 month after Dose 4
|
AEs occurring from Dose 4 to 1 month after Dose 4
|
Dose 4 to 1 month after Dose 4
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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.
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)
4. maj 2026
Primær færdiggørelse (Anslået)
30. december 2028
Studieafslutning (Anslået)
30. december 2028
Datoer for studieregistrering
Først indsendt
30. april 2026
Først indsendt, der opfyldte QC-kriterier
30. april 2026
Først opslået (Faktiske)
7. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
15. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- C4931007
- 2025 (U.S. NIH-bevilling/kontrakt: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- 2025-523447-35-00 (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
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 .