A Study to Learn About How a New Pneumococcal Vaccine Works in Infants.
4 de septiembre de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
3230
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Pfizer CT.gov Call Center
- Número de teléfono: 1-800-718-1021
- Correo electrónico: ClinicalTrials.gov_Inquiries@pfizer.com
Ubicaciones de estudio
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Alabama
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Bessemer, Alabama, Estados Unidos, 35022
- Aún no reclutando
- Kur Research, LLC
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Birmingham, Alabama, Estados Unidos, 35233
- Reclutamiento
- University of Alabama at Birmingham - School of Medicine
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Birmingham, Alabama, Estados Unidos, 35205
- Reclutamiento
- Alabama Clinical Therapeutics, LLC Birmingham Pediatric Associates
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Centreville, Alabama, Estados Unidos, 35042
- Aún no reclutando
- Kur Research, LLC
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Arkansas
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Fayetteville, Arkansas, Estados Unidos, 72703
- Reclutamiento
- Northwest Arkansas Pediatric Clinic
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Jonesboro, Arkansas, Estados Unidos, 72401
- Reclutamiento
- The Children's Clinic of Jonesboro, P.A.
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Sherwood, Arkansas, Estados Unidos, 72120
- Reclutamiento
- Helios Clinical Research
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California
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Anaheim, California, Estados Unidos, 92805
- Reclutamiento
- Advanced Research Center, Inc.
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Arcadia, California, Estados Unidos, 91007
- Reclutamiento
- San Gabriel Woman's Health
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Bellflower, California, Estados Unidos, 90706
- Reclutamiento
- Coast Clinical Research, LLC
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El Monte, California, Estados Unidos, 91731
- Reclutamiento
- Family Medical Clinic
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Fresno, California, Estados Unidos, 93704
- Reclutamiento
- Clinical Research of Central California
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Montebello, California, Estados Unidos, 90640
- Reclutamiento
- SeraCollection Research Services, LLC
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National City, California, Estados Unidos, 91950
- Reclutamiento
- Bailony Pediatrics
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Palo Alto, California, Estados Unidos, 94304
- Aún no reclutando
- Stanford University Medical Center
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
- Reclutamiento
- Childrens Hospital of Colorado
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Florida
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Hialeah, Florida, Estados Unidos, 33012
- Reclutamiento
- Direct Helpers Research Center
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Homestead, Florida, Estados Unidos, 33030
- Reclutamiento
- C & R Research Services USA
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Miami, Florida, Estados Unidos, 33155
- Reclutamiento
- Gold Coast Health Research Center, LLC
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Miami, Florida, Estados Unidos, 33155
- Reclutamiento
- Bioresearch Partner
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Miami, Florida, Estados Unidos, 33143
- Reclutamiento
- Florida Pharmaceutical Research and Associates, Inc.
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Miami, Florida, Estados Unidos, 33173
- Reclutamiento
- Dade Research Center
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Miami, Florida, Estados Unidos, 33183
- Reclutamiento
- Vasconcello-Cohen MD Research, LLC.
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Miami Lakes, Florida, Estados Unidos, 33014
- Reclutamiento
- Riveldi and Associates
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North Lauderdale, Florida, Estados Unidos, 33068
- Reclutamiento
- Eminent Clinical Research and Associates
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Sweetwater, Florida, Estados Unidos, 33182
- Reclutamiento
- Cordova Research Institute LLC
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Tampa, Florida, Estados Unidos, 33617
- Reclutamiento
- Children's Health Center
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Georgia
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Chamblee, Georgia, Estados Unidos, 30341
- Aún no reclutando
- ObjectiveHealth Clinical Research LLC - Chamblee
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Norcross, Georgia, Estados Unidos, 30093
- Reclutamiento
- Altruistic Clinical Research Global
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Idaho
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Ammon, Idaho, Estados Unidos, 83406
- Reclutamiento
- Medical Research Partners
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Blackfoot, Idaho, Estados Unidos, 83221
- Reclutamiento
- Bingham Memorial Hospital
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Boise, Idaho, Estados Unidos, 83702
- Reclutamiento
- ASR, LLC
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Idaho Falls, Idaho, Estados Unidos, 83404
- Reclutamiento
- Leavitt Clinical Research
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Illinois
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Moline, Illinois, Estados Unidos, 61265
- Reclutamiento
- MidValley Research, Inc
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Iowa
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Ankeny, Iowa, Estados Unidos, 50023
- Reclutamiento
- The Iowa Clinic.
-
West Des Moines, Iowa, Estados Unidos, 50265
- Reclutamiento
- Eximia Research - IA, LLC (dba Integrated Clinical Trial Services, LLC)
-
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Kansas
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Derby, Kansas, Estados Unidos, 67037
- Reclutamiento
- Integrity Clinical Network, LLC
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Louisiana
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Haughton, Louisiana, Estados Unidos, 71037
- Reclutamiento
- ACC Pediatric Research
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Maryland
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Baltimore, Maryland, Estados Unidos, 21201
- Aún no reclutando
- University of Maryland, Baltimore, Center for Vaccine Development and Global Health
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Columbia, Maryland, Estados Unidos, 21045
- Aún no reclutando
- The Pediatric Center
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Columbia, Maryland, Estados Unidos, 21045
- Reclutamiento
- Kur Research, LLC
-
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Michigan
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Allen Park, Michigan, Estados Unidos, 48101
- Reclutamiento
- Michigan Institute of Research
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Bingham Farms, Michigan, Estados Unidos, 48025
- Reclutamiento
- Michigan Center of Medical Research
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Dearborn Heights, Michigan, Estados Unidos, 48127
- Reclutamiento
- Vida Clinical Studies, LLC
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-
Missouri
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Columbia, Missouri, Estados Unidos, 65212
- Reclutamiento
- University of Missouri
-
Columbia, Missouri, Estados Unidos, 65201
- Reclutamiento
- University of Missouri Pediatrics Clinic-South Providence
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Nebraska
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Grand Island, Nebraska, Estados Unidos, 68803
- Reclutamiento
- Velocity Clinical Research, Grand Island
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Lincoln, Nebraska, Estados Unidos, 68504
- Reclutamiento
- Midwest Children's Health Research Institute
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Lincoln, Nebraska, Estados Unidos, 68505
- Reclutamiento
- Midwest Children's Health Research Institute
-
Lincoln, Nebraska, Estados Unidos, 68516
- Reclutamiento
- Midwest Children's Health Research Institute
-
Lincoln, Nebraska, Estados Unidos, 68522
- Reclutamiento
- Midwest Children's Health Research Institute
-
-
New York
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East Syracuse, New York, Estados Unidos, 13057
- Reclutamiento
- Child Health Care Associates
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Rochester, New York, Estados Unidos, 14642
- Reclutamiento
- University of Rochester Medical Center
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North Carolina
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Charlotte, North Carolina, Estados Unidos, 28203
- Reclutamiento
- Atrium Health Cannon Research Cente
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Charlotte, North Carolina, Estados Unidos, 28207
- Reclutamiento
- Atrium Health - STRIVE Research clinic
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Charlotte, North Carolina, Estados Unidos, 28207
- Reclutamiento
- Atrium Health Levine Children's Myers Park Pediatrics
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Durham, North Carolina, Estados Unidos, 27703
- Reclutamiento
- Duke Vaccine and Trials Unit
-
Durham, North Carolina, Estados Unidos, 27704
- Reclutamiento
- Durham Pediatrics at North Duke Street
-
Matthews, North Carolina, Estados Unidos, 28105
- Reclutamiento
- Atrium Health Levine Children's Charlotte Pediatrics
-
Matthews, North Carolina, Estados Unidos, 28105
- Reclutamiento
- Atrium Health STRIVE Research Clinic - Matthews
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Wilmington, North Carolina, Estados Unidos, 28405
- Reclutamiento
- Wilmington Health
-
-
Ohio
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Cincinnati, Ohio, Estados Unidos, 45245
- Reclutamiento
- Pediatric Associates of Mt. Carmel
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Dayton, Ohio, Estados Unidos, 45429
- Reclutamiento
- PriMed Clinical Research
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South Euclid, Ohio, Estados Unidos, 44121
- Reclutamiento
- Senders Pediatrics
-
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Pennsylvania
-
Bellevue, Pennsylvania, Estados Unidos, 15202
- Reclutamiento
- UPMC Children's Community Pediatrics- Bellevue
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Cranberry Township, Pennsylvania, Estados Unidos, 16066
- Reclutamiento
- UPMC Children's Community Pediatrics Bass Wolfson-Cranberry
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Erie, Pennsylvania, Estados Unidos, 16506
- Reclutamiento
- Allegheny Health and Wellness Pavilion
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Jefferson Hills, Pennsylvania, Estados Unidos, 15025
- Reclutamiento
- UPMC Children's Community Pediatrics South Hills-Jefferson Hills
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N. Huntingdon, Pennsylvania, Estados Unidos, 15642
- Reclutamiento
- UPMC Children's Community Pediatrics - Norwin
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Pittsburgh, Pennsylvania, Estados Unidos, 15217
- Reclutamiento
- UPMC Children's Community Pediatrics Bass Wolfson-Squirrel Hill
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Pittsburgh, Pennsylvania, Estados Unidos, 15234
- Reclutamiento
- UPMC Children's Community Pediatrics-Castle Shannon
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- Reclutamiento
- UPMC Children's Hospital of Pittsburgh Primary Care Center-Oakland
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Pittsburgh, Pennsylvania, Estados Unidos, 15227
- Reclutamiento
- UPMC Children's Community Pediatrics-Brentwood
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South Carolina
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Simpsonville, South Carolina, Estados Unidos, 29680
- Reclutamiento
- Tribe Clinical Research LLC. at Parkside Pediatrics Harrison Bridge Road
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Summerville, South Carolina, Estados Unidos, 29486
- Reclutamiento
- Carolina Family Care
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Summerville, South Carolina, Estados Unidos, 29486
- Reclutamiento
- MUSC Children's Health
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Tennessee
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Memphis, Tennessee, Estados Unidos, 38105
- Aún no reclutando
- Le Bonheur Children's Hospital - Outpatient Building
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Tullahoma, Tennessee, Estados Unidos, 37388
- Reclutamiento
- Pediatric Clinical Trials of Tennessee, LLC
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Texas
-
Brownsville, Texas, Estados Unidos, 78520
- Reclutamiento
- Proactive RGV
-
Corpus Christi, Texas, Estados Unidos, 78404
- Aún no reclutando
- South Texas Clinical Research
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Edinburg, Texas, Estados Unidos, 78539
- Reclutamiento
- Proactive Clinical Research LLC
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El Paso, Texas, Estados Unidos, 79902
- Reclutamiento
- Proactive El Paso,LLC
-
Forney, Texas, Estados Unidos, 75126
- Reclutamiento
- SMS Clinical Research LLC.
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Galveston, Texas, Estados Unidos, 77555
- Reclutamiento
- University of Texas Medical Branch, Sealy Institute for Vaccine Sciences Clinical Trials Program
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Houston, Texas, Estados Unidos, 77065
- Reclutamiento
- Kool Kids Pediatrics
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Houston, Texas, Estados Unidos, 77090
- Reclutamiento
- Houston Clinical Research Associates
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Houston, Texas, Estados Unidos, 77054
- Reclutamiento
- Mercury Clinical Research (Administrative Office)
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Houston, Texas, Estados Unidos, 77077
- Reclutamiento
- Mercury Clinical Research - Sunrise Pediatrics
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Houston, Texas, Estados Unidos, 77042
- Reclutamiento
- Neutra Life Sciences
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Houston, Texas, Estados Unidos, 77087
- Reclutamiento
- Mercury Clinical Research - MD Kids Pediatrics
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Houston, Texas, Estados Unidos, 77057
- Aún no reclutando
- UDL Clinical Research, LLC.
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Houston, Texas, Estados Unidos, 77074
- Reclutamiento
- Aavon Clinical Trials, LLC.
-
Houston, Texas, Estados Unidos, 77074
- Reclutamiento
- RTX Clinical Research
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Lewisville, Texas, Estados Unidos, 75067
- Reclutamiento
- Prime Clinical Research - Lewisville
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Mansfield, Texas, Estados Unidos, 76063
- Reclutamiento
- Prime Clinical Research - Mansfield
-
McAllen, Texas, Estados Unidos, 78504
- Reclutamiento
- Dr. Ruben Aleman & Associates
-
Mesquite, Texas, Estados Unidos, 75149
- Reclutamiento
- SMS Clinical Research LLC
-
Mesquite, Texas, Estados Unidos, 75150
- Reclutamiento
- SMS Clinical Research LLC
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Richmond, Texas, Estados Unidos, 77469
- Reclutamiento
- Pediatric Center- Neutra Life Sciences
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San Antonio, Texas, Estados Unidos, 78215
- Reclutamiento
- Sun Research Institute
-
Victoria, Texas, Estados Unidos, 77901
- Aún no reclutando
- Crossroads Clinical Research
-
-
Utah
-
Provo, Utah, Estados Unidos, 84604
- Reclutamiento
- AMR Clinical
-
Syracuse, Utah, Estados Unidos, 84075
- Reclutamiento
- AMR Clinical
-
-
Virginia
-
Richmond, Virginia, Estados Unidos, 23226
- Reclutamiento
- Clinical Research Partners, LLC
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Richmond, Virginia, Estados Unidos, 23233
- Reclutamiento
- Tekton Research, LLC.
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Wisconsin
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Marshfield, Wisconsin, Estados Unidos, 54449
- Reclutamiento
- Marshfield Medical Center - Marshfield
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-
-
-
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Fukui, Japón, 910-0833
- Reclutamiento
- Fukui Aiiku Hospital
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Fukuoka, Japón, 813-0036
- Reclutamiento
- Fukazawa Pediatric Clinic
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Osaka, Japón, 544-0033
- Reclutamiento
- Kubota Children's Clinic
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Aichi-ken
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Toyota-shi, Aichi-ken, Japón, 471-8513
- Reclutamiento
- Toyota Memorial Hospital
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Fukuoka
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Fukuoka, Fukuoka, Japón, 814-0121
- Reclutamiento
- Shindo children's clinic
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Kasuga, Fukuoka, Japón, 816-0801
- Reclutamiento
- Yokoyama Children'S Clinic
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Hokkaido
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Sapporo, Hokkaido, Japón, 062-0907
- Reclutamiento
- Ohigesenseino Kodomo Clinic
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Kagoshima-ken
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Hioki, Kagoshima-ken, Japón, 899-2503
- Reclutamiento
- Nintenkaikagoshima Children's Hospital
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Tokyo
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Shinjuku-ku, Tokyo, Japón, 160-0017
- Reclutamiento
- Futaba Clinic
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Yamanashi
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Kofu, Yamanashi, Japón, 400-0853
- Reclutamiento
- Kose Children Clinic
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-
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Bayamón, Puerto Rico, 00960
- Reclutamiento
- Clinical Research Investigator Group
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Caguas, Puerto Rico, 00726
- Reclutamiento
- San Juan Bautista School of Medicine - Clinical Research Unit
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Caguas, Puerto Rico, 00725
- Reclutamiento
- Caguas Clinical Research
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Guayama, Puerto Rico, 00784
- Reclutamiento
- Clinical Research Puerto Rico
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Ponce, Puerto Rico, 00716
- Reclutamiento
- Ponce Medical School Foundation Inc./ CAIMED Center
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Ponce, Puerto Rico, 00728
- Reclutamiento
- BRCR Global Puerto Rico
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San Juan, Puerto Rico, 00907
- Reclutamiento
- BRCR Global Puerto Rico
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Trujillo Alto, Puerto Rico, 00976-3910
- Reclutamiento
- San Miguel Medical
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Sí
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Group 1 PG4 (intramuscular)
Multivalent Pneumococcal Vaccine
|
Multivalent Pneumococcal Vaccine
|
|
Comparador activo: Group 1 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)
20-valent pneumococcal conjugate vaccine (20vPnC)
|
Vacuna antineumocócica conjugada 20-valente (20vPnC)
Otros nombres:
|
|
Experimental: Group 2 PG4 (intramuscular)
Multivalent Pneumococcal Vaccine
|
Multivalent Pneumococcal Vaccine
|
|
Comparador activo: Group 2 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)
20-valent pneumococcal conjugate vaccine (20vPnC)
|
Vacuna antineumocócica conjugada 20-valente (20vPnC)
Otros nombres:
|
|
Experimental: Group 3 PG4 (intramuscular)
Multivalent Pneumococcal Vaccine
|
Multivalent Pneumococcal Vaccine
|
|
Experimental: Group 3 PG4 (subcutaneous)
Multivalent Pneumococcal Vaccine
|
Multivalent Pneumococcal Vaccine
|
|
Comparador activo: Group 3 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)
20-valent pneumococcal conjugate vaccine (20vPnC)
|
Vacuna antineumocócica conjugada 20-valente (20vPnC)
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Porcentaje de participantes que informaron reacciones locales dentro de los 7 días posteriores a cada dosis
Periodo de tiempo: Día 7
|
Reacciones locales provocadas después de cada dosis.
|
Día 7
|
|
Porcentaje de participantes que informaron eventos adversos graves (AAG)
Periodo de tiempo: Dosis de 1 a 6 meses después de la Dosis 4
|
AAG que ocurren desde la dosis 1 hasta 6 meses después de la dosis 4
|
Dosis de 1 a 6 meses después de la Dosis 4
|
|
Percentage of participants reporting systemic events within 7 days after each dose
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 1 month after Dose 4
|
Pneumococcal IgG GMCs 1 month after Dose 4
|
1 month after Dose 4
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pneumococcal IgG GMCs 1 month after Dose 3
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Prior to Dose 4
|
Pneumococcal OPA titers prior to Dose 4
|
Prior to Dose 4
|
|
Pneumococcal OPA titers 1 month after Dose 4
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Prior to Dose 4
|
Pneumococcal IgG concentrations prior to Dose 4
|
Prior to Dose 4
|
|
Pneumococcal IgG concentrations 1 month after Dose 4
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 1 month after Dose 3
|
Geometric mean of IgA antibody levels to rotavirus 1 month after Dose 3
|
1 month after Dose 3
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Pfizer CT.gov Call Center, Pfizer
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
29 de mayo de 2026
Finalización primaria (Estimado)
5 de junio de 2029
Finalización del estudio (Estimado)
5 de junio de 2029
Fechas de registro del estudio
Enviado por primera vez
27 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
4 de junio de 2026
Publicado por primera vez (Actual)
5 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
8 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
4 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- C4931008
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .