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A Study to Learn About How a New Pneumococcal Vaccine Works in Infants.

4 settembre 2026 aggiornato da: Pfizer

A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY 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. It will also assess how the new vaccine works in comparison to the one that is currently in use when given with other childhood vaccines.

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 infants. Pneumococcal disease includes a variety of infections caused by a specific germ, Streptococcus pneumoniae.

There are three groups in this study. All participants will be assigned to one of the three groups. This study is seeking participants who are:

  • infants who are 2 months of age in Group 1;
  • infants who are 2 to 6 months of age in Groups 2 and 3; and
  • said to be healthy by the study doctor

About 3000 infants will be assigned to Group 1. The infants in this group will have a 1 in 2 chance (50%) of receiving 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.

About 140 infants from outside the United States will be assigned to Group 2. The infants in this group will have a 1 in 2 chance (50%) of receiving either PG4 or 20vPnC into the left thigh muscle at 2 to 6, 3 to 8, 4 to 10, and 12 to 15 months of age.

About 90 infants from outside the United States will be assigned to Group 3. The infants in Group 3 will have a 1 in 3 chance (33%) of receiving either PG4 into the left thigh muscle, PG4 under the skin of the left thigh, or 20vPnC into the left thigh muscle at 2 to 6, 3 to 8, 4 to 10, and 12 to 15 months of age.

Infants in Group 1 will take part in this study for about 16 to 19 months (about 1 and a half years). Infants in Groups 2 and 3 will take part in this study for 12 to 21 months (about 1 to 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. Infants will have 3 blood samples collected.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

3230

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Giappone
      • Fukui, Giappone, 910-0833
        • Reclutamento
        • Fukui Aiiku Hospital
      • Fukuoka, Giappone, 813-0036
        • Reclutamento
        • Fukazawa Pediatric Clinic
      • Osaka, Giappone, 544-0033
        • Reclutamento
        • Kubota Children's Clinic
    • Aichi-ken
      • Toyota-shi, Aichi-ken, Giappone, 471-8513
        • Reclutamento
        • Toyota Memorial Hospital
    • Fukuoka
      • Fukuoka, Fukuoka, Giappone, 814-0121
        • Reclutamento
        • Shindo children's clinic
      • Kasuga, Fukuoka, Giappone, 816-0801
        • Reclutamento
        • Yokoyama Children'S Clinic
    • Hokkaido
      • Sapporo, Hokkaido, Giappone, 062-0907
        • Reclutamento
        • Ohigesenseino Kodomo Clinic
    • Kagoshima-ken
      • Hioki, Kagoshima-ken, Giappone, 899-2503
        • Reclutamento
        • Nintenkaikagoshima Children's Hospital
    • Tokyo
      • Shinjuku-ku, Tokyo, Giappone, 160-0017
        • Reclutamento
        • Futaba Clinic
    • Yamanashi
      • Kofu, Yamanashi, Giappone, 400-0853
        • Reclutamento
        • Kose Children Clinic
  • Porto Rico
      • Bayamón, Porto Rico, 00960
        • Reclutamento
        • Clinical Research Investigator Group
      • Caguas, Porto Rico, 00726
        • Reclutamento
        • San Juan Bautista School of Medicine - Clinical Research Unit
      • Caguas, Porto Rico, 00725
        • Reclutamento
        • Caguas Clinical Research
      • Guayama, Porto Rico, 00784
        • Reclutamento
        • Clinical Research Puerto Rico
      • Ponce, Porto Rico, 00716
        • Reclutamento
        • Ponce Medical School Foundation Inc./ CAIMED Center
      • Ponce, Porto Rico, 00728
        • Reclutamento
        • BRCR Global Puerto Rico
      • San Juan, Porto Rico, 00907
        • Reclutamento
        • BRCR Global Puerto Rico
      • Trujillo Alto, Porto Rico, 00976-3910
        • Reclutamento
        • San Miguel Medical
  • Stati Uniti
    • Alabama
      • Bessemer, Alabama, Stati Uniti, 35022
        • Non ancora reclutamento
        • Kur Research, LLC
      • Birmingham, Alabama, Stati Uniti, 35233
        • Reclutamento
        • University of Alabama at Birmingham - School of Medicine
      • Birmingham, Alabama, Stati Uniti, 35205
        • Reclutamento
        • Alabama Clinical Therapeutics, LLC Birmingham Pediatric Associates
      • Centreville, Alabama, Stati Uniti, 35042
        • Non ancora reclutamento
        • Kur Research, LLC
    • Arkansas
      • Fayetteville, Arkansas, Stati Uniti, 72703
        • Reclutamento
        • Northwest Arkansas Pediatric Clinic
      • Jonesboro, Arkansas, Stati Uniti, 72401
        • Reclutamento
        • The Children's Clinic of Jonesboro, P.A.
      • Sherwood, Arkansas, Stati Uniti, 72120
        • Reclutamento
        • Helios Clinical Research
    • California
      • Anaheim, California, Stati Uniti, 92805
        • Reclutamento
        • Advanced Research Center, Inc.
      • Arcadia, California, Stati Uniti, 91007
        • Reclutamento
        • San Gabriel Woman's Health
      • Bellflower, California, Stati Uniti, 90706
        • Reclutamento
        • Coast Clinical Research, LLC
      • El Monte, California, Stati Uniti, 91731
        • Reclutamento
        • Family Medical Clinic
      • Fresno, California, Stati Uniti, 93704
        • Reclutamento
        • Clinical Research of Central California
      • Montebello, California, Stati Uniti, 90640
        • Reclutamento
        • SeraCollection Research Services, LLC
      • National City, California, Stati Uniti, 91950
        • Reclutamento
        • Bailony Pediatrics
      • Palo Alto, California, Stati Uniti, 94304
        • Non ancora reclutamento
        • Stanford University Medical Center
    • Colorado
      • Aurora, Colorado, Stati Uniti, 80045
        • Reclutamento
        • Childrens Hospital of Colorado
    • Florida
      • Hialeah, Florida, Stati Uniti, 33012
        • Reclutamento
        • Direct Helpers Research Center
      • Homestead, Florida, Stati Uniti, 33030
        • Reclutamento
        • C & R Research Services USA
      • Miami, Florida, Stati Uniti, 33155
        • Reclutamento
        • Gold Coast Health Research Center, LLC
      • Miami, Florida, Stati Uniti, 33155
        • Reclutamento
        • Bioresearch Partner
      • Miami, Florida, Stati Uniti, 33143
        • Reclutamento
        • Florida Pharmaceutical Research and Associates, Inc.
      • Miami, Florida, Stati Uniti, 33173
        • Reclutamento
        • Dade Research Center
      • Miami, Florida, Stati Uniti, 33183
        • Reclutamento
        • Vasconcello-Cohen MD Research, LLC.
      • Miami Lakes, Florida, Stati Uniti, 33014
        • Reclutamento
        • Riveldi and Associates
      • North Lauderdale, Florida, Stati Uniti, 33068
        • Reclutamento
        • Eminent Clinical Research and Associates
      • Sweetwater, Florida, Stati Uniti, 33182
        • Reclutamento
        • Cordova Research Institute LLC
      • Tampa, Florida, Stati Uniti, 33617
        • Reclutamento
        • Children's Health Center
    • Georgia
      • Chamblee, Georgia, Stati Uniti, 30341
        • Non ancora reclutamento
        • ObjectiveHealth Clinical Research LLC - Chamblee
      • Norcross, Georgia, Stati Uniti, 30093
        • Reclutamento
        • Altruistic Clinical Research Global
    • Idaho
      • Ammon, Idaho, Stati Uniti, 83406
        • Reclutamento
        • Medical Research Partners
      • Blackfoot, Idaho, Stati Uniti, 83221
        • Reclutamento
        • Bingham Memorial Hospital
      • Boise, Idaho, Stati Uniti, 83702
        • Reclutamento
        • ASR, LLC
      • Idaho Falls, Idaho, Stati Uniti, 83404
        • Reclutamento
        • Leavitt Clinical Research
    • Illinois
      • Moline, Illinois, Stati Uniti, 61265
        • Reclutamento
        • MidValley Research, Inc
    • Iowa
      • Ankeny, Iowa, Stati Uniti, 50023
        • Reclutamento
        • The Iowa Clinic.
      • West Des Moines, Iowa, Stati Uniti, 50265
        • Reclutamento
        • Eximia Research - IA, LLC (dba Integrated Clinical Trial Services, LLC)
    • Kansas
      • Derby, Kansas, Stati Uniti, 67037
        • Reclutamento
        • Integrity Clinical Network, LLC
    • Louisiana
      • Haughton, Louisiana, Stati Uniti, 71037
        • Reclutamento
        • ACC Pediatric Research
    • Maryland
      • Baltimore, Maryland, Stati Uniti, 21201
        • Non ancora reclutamento
        • University of Maryland, Baltimore, Center for Vaccine Development and Global Health
      • Columbia, Maryland, Stati Uniti, 21045
        • Non ancora reclutamento
        • The Pediatric Center
      • Columbia, Maryland, Stati Uniti, 21045
        • Reclutamento
        • Kur Research, LLC
    • Michigan
      • Allen Park, Michigan, Stati Uniti, 48101
        • Reclutamento
        • Michigan Institute of Research
      • Bingham Farms, Michigan, Stati Uniti, 48025
        • Reclutamento
        • Michigan Center of Medical Research
      • Dearborn Heights, Michigan, Stati Uniti, 48127
        • Reclutamento
        • Vida Clinical Studies, LLC
    • Missouri
      • Columbia, Missouri, Stati Uniti, 65212
        • Reclutamento
        • University of Missouri
      • Columbia, Missouri, Stati Uniti, 65201
        • Reclutamento
        • University of Missouri Pediatrics Clinic-South Providence
    • Nebraska
      • Grand Island, Nebraska, Stati Uniti, 68803
        • Reclutamento
        • Velocity Clinical Research, Grand Island
      • Lincoln, Nebraska, Stati Uniti, 68504
        • Reclutamento
        • Midwest Children's Health Research Institute
      • Lincoln, Nebraska, Stati Uniti, 68505
        • Reclutamento
        • Midwest Children's Health Research Institute
      • Lincoln, Nebraska, Stati Uniti, 68516
        • Reclutamento
        • Midwest Children's Health Research Institute
      • Lincoln, Nebraska, Stati Uniti, 68522
        • Reclutamento
        • Midwest Children's Health Research Institute
    • New York
      • East Syracuse, New York, Stati Uniti, 13057
        • Reclutamento
        • Child Health Care Associates
      • Rochester, New York, Stati Uniti, 14642
        • Reclutamento
        • University of Rochester Medical Center
    • North Carolina
      • Charlotte, North Carolina, Stati Uniti, 28203
        • Reclutamento
        • Atrium Health Cannon Research Cente
      • Charlotte, North Carolina, Stati Uniti, 28207
        • Reclutamento
        • Atrium Health - STRIVE Research clinic
      • Charlotte, North Carolina, Stati Uniti, 28207
        • Reclutamento
        • Atrium Health Levine Children's Myers Park Pediatrics
      • Durham, North Carolina, Stati Uniti, 27703
        • Reclutamento
        • Duke Vaccine and Trials Unit
      • Durham, North Carolina, Stati Uniti, 27704
        • Reclutamento
        • Durham Pediatrics at North Duke Street
      • Matthews, North Carolina, Stati Uniti, 28105
        • Reclutamento
        • Atrium Health Levine Children's Charlotte Pediatrics
      • Matthews, North Carolina, Stati Uniti, 28105
        • Reclutamento
        • Atrium Health STRIVE Research Clinic - Matthews
      • Wilmington, North Carolina, Stati Uniti, 28405
        • Reclutamento
        • Wilmington Health
    • Ohio
      • Cincinnati, Ohio, Stati Uniti, 45245
        • Reclutamento
        • Pediatric Associates of Mt. Carmel
      • Dayton, Ohio, Stati Uniti, 45429
        • Reclutamento
        • PriMed Clinical Research
      • South Euclid, Ohio, Stati Uniti, 44121
        • Reclutamento
        • Senders Pediatrics
    • Pennsylvania
      • Bellevue, Pennsylvania, Stati Uniti, 15202
        • Reclutamento
        • UPMC Children's Community Pediatrics- Bellevue
      • Cranberry Township, Pennsylvania, Stati Uniti, 16066
        • Reclutamento
        • UPMC Children's Community Pediatrics Bass Wolfson-Cranberry
      • Erie, Pennsylvania, Stati Uniti, 16506
        • Reclutamento
        • Allegheny Health and Wellness Pavilion
      • Jefferson Hills, Pennsylvania, Stati Uniti, 15025
        • Reclutamento
        • UPMC Children's Community Pediatrics South Hills-Jefferson Hills
      • N. Huntingdon, Pennsylvania, Stati Uniti, 15642
        • Reclutamento
        • UPMC Children's Community Pediatrics - Norwin
      • Pittsburgh, Pennsylvania, Stati Uniti, 15217
        • Reclutamento
        • UPMC Children's Community Pediatrics Bass Wolfson-Squirrel Hill
      • Pittsburgh, Pennsylvania, Stati Uniti, 15234
        • Reclutamento
        • UPMC Children's Community Pediatrics-Castle Shannon
      • Pittsburgh, Pennsylvania, Stati Uniti, 15213
        • Reclutamento
        • UPMC Children's Hospital of Pittsburgh Primary Care Center-Oakland
      • Pittsburgh, Pennsylvania, Stati Uniti, 15227
        • Reclutamento
        • UPMC Children's Community Pediatrics-Brentwood
    • South Carolina
      • Simpsonville, South Carolina, Stati Uniti, 29680
        • Reclutamento
        • Tribe Clinical Research LLC. at Parkside Pediatrics Harrison Bridge Road
      • Summerville, South Carolina, Stati Uniti, 29486
        • Reclutamento
        • Carolina Family Care
      • Summerville, South Carolina, Stati Uniti, 29486
        • Reclutamento
        • MUSC Children's Health
    • Tennessee
      • Memphis, Tennessee, Stati Uniti, 38105
        • Non ancora reclutamento
        • Le Bonheur Children's Hospital - Outpatient Building
      • Tullahoma, Tennessee, Stati Uniti, 37388
        • Reclutamento
        • Pediatric Clinical Trials of Tennessee, LLC
    • Texas
      • Brownsville, Texas, Stati Uniti, 78520
        • Reclutamento
        • Proactive RGV
      • Corpus Christi, Texas, Stati Uniti, 78404
        • Non ancora reclutamento
        • South Texas Clinical Research
      • Edinburg, Texas, Stati Uniti, 78539
        • Reclutamento
        • Proactive Clinical Research LLC
      • El Paso, Texas, Stati Uniti, 79902
        • Reclutamento
        • Proactive El Paso,LLC
      • Forney, Texas, Stati Uniti, 75126
        • Reclutamento
        • SMS Clinical Research LLC.
      • Galveston, Texas, Stati Uniti, 77555
        • Reclutamento
        • University of Texas Medical Branch, Sealy Institute for Vaccine Sciences Clinical Trials Program
      • Houston, Texas, Stati Uniti, 77065
        • Reclutamento
        • Kool Kids Pediatrics
      • Houston, Texas, Stati Uniti, 77090
        • Reclutamento
        • Houston Clinical Research Associates
      • Houston, Texas, Stati Uniti, 77054
        • Reclutamento
        • Mercury Clinical Research (Administrative Office)
      • Houston, Texas, Stati Uniti, 77077
        • Reclutamento
        • Mercury Clinical Research - Sunrise Pediatrics
      • Houston, Texas, Stati Uniti, 77042
        • Reclutamento
        • Neutra Life Sciences
      • Houston, Texas, Stati Uniti, 77087
        • Reclutamento
        • Mercury Clinical Research - MD Kids Pediatrics
      • Houston, Texas, Stati Uniti, 77057
        • Non ancora reclutamento
        • UDL Clinical Research, LLC.
      • Houston, Texas, Stati Uniti, 77074
        • Reclutamento
        • Aavon Clinical Trials, LLC.
      • Houston, Texas, Stati Uniti, 77074
        • Reclutamento
        • RTX Clinical Research
      • Lewisville, Texas, Stati Uniti, 75067
        • Reclutamento
        • Prime Clinical Research - Lewisville
      • Mansfield, Texas, Stati Uniti, 76063
        • Reclutamento
        • Prime Clinical Research - Mansfield
      • McAllen, Texas, Stati Uniti, 78504
        • Reclutamento
        • Dr. Ruben Aleman & Associates
      • Mesquite, Texas, Stati Uniti, 75149
        • Reclutamento
        • SMS Clinical Research LLC
      • Mesquite, Texas, Stati Uniti, 75150
        • Reclutamento
        • SMS Clinical Research LLC
      • Richmond, Texas, Stati Uniti, 77469
        • Reclutamento
        • Pediatric Center- Neutra Life Sciences
      • San Antonio, Texas, Stati Uniti, 78215
        • Reclutamento
        • Sun Research Institute
      • Victoria, Texas, Stati Uniti, 77901
        • Non ancora reclutamento
        • Crossroads Clinical Research
    • Utah
      • Provo, Utah, Stati Uniti, 84604
        • Reclutamento
        • AMR Clinical
      • Syracuse, Utah, Stati Uniti, 84075
        • Reclutamento
        • AMR Clinical
    • Virginia
      • Richmond, Virginia, Stati Uniti, 23226
        • Reclutamento
        • Clinical Research Partners, LLC
      • Richmond, Virginia, Stati Uniti, 23233
        • Reclutamento
        • Tekton Research, LLC.
    • Wisconsin
      • Marshfield, Wisconsin, Stati Uniti, 54449
        • Reclutamento
        • Marshfield Medical Center - Marshfield

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino

Accetta volontari sani

Sì

Descrizione

Inclusion Criteria:

  • infants who are 2 months of age in Group 1.
  • infants who are 2 to 6 months of age in Groups 2 and 3.
  • 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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Group 1 PG4 (intramuscular)
Multivalent Pneumococcal Vaccine
Biologico: PG4
Multivalent Pneumococcal Vaccine
Comparatore attivo: Group 1 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)
20-valent pneumococcal conjugate vaccine (20vPnC)
Biologico: Vaccino pneumococcico coniugato 20-valente (20vPnC)
Vaccino pneumococcico coniugato 20-valente (20vPnC)
Altri nomi:
  • Prevnar 20
Sperimentale: Group 2 PG4 (intramuscular)
Multivalent Pneumococcal Vaccine
Biologico: PG4
Multivalent Pneumococcal Vaccine
Comparatore attivo: Group 2 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)
20-valent pneumococcal conjugate vaccine (20vPnC)
Biologico: Vaccino pneumococcico coniugato 20-valente (20vPnC)
Vaccino pneumococcico coniugato 20-valente (20vPnC)
Altri nomi:
  • Prevnar 20
Sperimentale: Group 3 PG4 (intramuscular)
Multivalent Pneumococcal Vaccine
Biologico: PG4
Multivalent Pneumococcal Vaccine
Sperimentale: Group 3 PG4 (subcutaneous)
Multivalent Pneumococcal Vaccine
Biologico: PG4
Multivalent Pneumococcal Vaccine
Comparatore attivo: Group 3 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)
20-valent pneumococcal conjugate vaccine (20vPnC)
Biologico: Vaccino pneumococcico coniugato 20-valente (20vPnC)
Vaccino pneumococcico coniugato 20-valente (20vPnC)
Altri nomi:
  • Prevnar 20

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentuale di partecipanti che hanno segnalato reazioni locali entro 7 giorni dopo ciascuna dose
Lasso di tempo: Giorno 7
Reazioni locali sollecitate dopo ogni dose
Giorno 7
Percentuale di partecipanti che hanno segnalato eventi avversi gravi (SAE)
Lasso di tempo: Dose da 1 a 6 mesi dopo la Dose 4
SAE che si verificano dalla Dose 1 a 6 mesi dopo la Dose 4
Dose da 1 a 6 mesi dopo la Dose 4
Percentage of participants reporting systemic events within 7 days after each dose
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Differences in percentages of participants with predefined pneumococcal specific immunoglobulin G (IgG) concentrations 1 month after Dose 3
Lasso di tempo: 1 month after Dose 3
Differences in pneumococcal immunoglobulin G (IgG) concentrations 1 month after Dose 3
1 month after Dose 3
Pneumococcal IgG geometric mean concentrations (GMCs) 1 month after Dose 4
Lasso di tempo: 1 month after Dose 4
Pneumococcal IgG GMCs 1 month after Dose 4
1 month after Dose 4

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pneumococcal IgG GMCs 1 month after Dose 3
Lasso di tempo: 1 month after Dose 3
Pneumococcal IgG GMCs 1 month after Dose 3
1 month after Dose 3
Percentage of participants with serotype 3 specific predefined pneumococcal IgG concentrations 1 month after Dose 3
Lasso di tempo: 1 month after Dose 3
Pneumococcal serotype 3 IgG concentrations 1 month after Dose 3
1 month after Dose 3
Pneumococcal serotype 3 IgG GMCs 1 month after Dose 4
Lasso di tempo: 1 month after Dose 4
Pneumococcal serotype 3 IgG GMCs 1 month after Dose 4
1 month after Dose 4
Differences in percentages of participants with predefined pneumococcal serotype 6C and 15C immunoglobulin G (IgG) concentrations 1 month after Dose 3
Lasso di tempo: 1 month after Dose 3
Differences in pneumococcal serotype 6C and 15C immunoglobulin G (IgG) concentrations 1 month after Dose 3
1 month after Dose 3
Pneumococcal serotype 6C and 15C IgG GMCs and GMRs 1 month after Dose 4
Lasso di tempo: 1 month after Dose 4
Pneumococcal serotype 6C and 15C IgG GMCs and GMRs 1 month after Dose 4
1 month after Dose 4
Pneumococcal opsonophagocytic activity (OPA) titers 1 month after Dose 3
Lasso di tempo: 1 month after Dose 3
Pneumococcal OPA titers 1 month after Dose 3
1 month after Dose 3
Pneumococcal OPA titers prior to Dose 4
Lasso di tempo: Prior to Dose 4
Pneumococcal OPA titers prior to Dose 4
Prior to Dose 4
Pneumococcal OPA titers 1 month after Dose 4
Lasso di tempo: 1 month after Dose 4
Pneumococcal OPA titers 1 month after Dose 4
1 month after Dose 4
Percentage of participants with predefined pneumococcal specific IgG concentrations 1 month after Dose 4
Lasso di tempo: 1 month after Dose 4
Percentage of participants with predefined pneumococcal specific IgG concentrations 1 month after Dose 4
1 month after Dose 4
Pneumococcal IgG concentrations 1 month after Dose 3
Lasso di tempo: 1 month after Dose 3
Pneumococcal IgG concentrations 1 month after Dose 3
1 month after Dose 3
Pneumococcal IgG concentrations prior to Dose 4
Lasso di tempo: Prior to Dose 4
Pneumococcal IgG concentrations prior to Dose 4
Prior to Dose 4
Pneumococcal IgG concentrations 1 month after Dose 4
Lasso di tempo: 1 month after Dose 4
Pneumococcal IgG concentrations 1 month after Dose 4
1 month after Dose 4
IgG geometric mean fold rise (GMFR) from before Dose 4 to 1 month after Dose 4
Lasso di tempo: Before Dose 4 to 1 month after Dose 4
IgG GMFR from before Dose 4 to 1 month after Dose 4
Before Dose 4 to 1 month after Dose 4
IgG GMFR from 1 month after Dose 3 to 1 month after Dose 4
Lasso di tempo: From 1 month after Dose 3 to 1 month after Dose 4
IgG GMFR from 1 month after Dose 3 to 1 month after Dose 4
From 1 month after Dose 3 to 1 month after Dose 4
Percentages of participants with prespecified antibody levels to specific concomitant vaccine antigens 1 month after Dose 3
Lasso di tempo: 1 month after Dose 3
Prespecified antibody levels to specific concomitant vaccine antigens 1 month after Dose 3
1 month after Dose 3
Geometric mean of antibody levels to measles, mumps, rubella, varicella, and hepatitis A virus antigens 1 month after Dose 4
Lasso di tempo: 1 month after Dose 4
Geometric mean of antibody levels to measles, mumps, rubella, varicella, and hepatitis A virus antigens 1 month after Dose 4
1 month after Dose 4
Geometric mean of immunoglobulin A (IgA) antibody levels to rotavirus 1 month after Dose 3
Lasso di tempo: 1 month after Dose 3
Geometric mean of IgA antibody levels to rotavirus 1 month after Dose 3
1 month after Dose 3

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Pfizer

Investigatori

  • Direttore dello studio: Pfizer CT.gov Call Center, Pfizer

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

29 maggio 2026

Completamento primario (Stimato)

5 giugno 2029

Completamento dello studio (Stimato)

5 giugno 2029

Date di iscrizione allo studio

Primo inviato

27 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

4 giugno 2026

Primo Inserito (Effettivo)

5 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • C4931008

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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