A Study to Learn About How a New Pneumococcal Vaccine Works in Infants.
2026년 9월 4일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (추정된)
3230
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Pfizer CT.gov Call Center
- 전화번호: 1-800-718-1021
- 이메일: ClinicalTrials.gov_Inquiries@pfizer.com
연구 장소
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Alabama
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Bessemer, Alabama, 미국, 35022
- 아직 모집하지 않음
- Kur Research, LLC
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Birmingham, Alabama, 미국, 35233
- 모병
- University of Alabama at Birmingham - School of Medicine
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Birmingham, Alabama, 미국, 35205
- 모병
- Alabama Clinical Therapeutics, LLC Birmingham Pediatric Associates
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Centreville, Alabama, 미국, 35042
- 아직 모집하지 않음
- Kur Research, LLC
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Arkansas
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Fayetteville, Arkansas, 미국, 72703
- 모병
- Northwest Arkansas Pediatric Clinic
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Jonesboro, Arkansas, 미국, 72401
- 모병
- The Children's Clinic of Jonesboro, P.A.
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Sherwood, Arkansas, 미국, 72120
- 모병
- Helios Clinical Research
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California
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Anaheim, California, 미국, 92805
- 모병
- Advanced Research Center, Inc.
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Arcadia, California, 미국, 91007
- 모병
- San Gabriel Woman's Health
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Bellflower, California, 미국, 90706
- 모병
- Coast Clinical Research, LLC
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El Monte, California, 미국, 91731
- 모병
- Family Medical Clinic
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Fresno, California, 미국, 93704
- 모병
- Clinical Research of Central California
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Montebello, California, 미국, 90640
- 모병
- SeraCollection Research Services, LLC
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National City, California, 미국, 91950
- 모병
- Bailony Pediatrics
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Palo Alto, California, 미국, 94304
- 아직 모집하지 않음
- Stanford University Medical Center
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Colorado
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Aurora, Colorado, 미국, 80045
- 모병
- Childrens Hospital of Colorado
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Florida
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Hialeah, Florida, 미국, 33012
- 모병
- Direct Helpers Research Center
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Homestead, Florida, 미국, 33030
- 모병
- C & R Research Services USA
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Miami, Florida, 미국, 33155
- 모병
- Gold Coast Health Research Center, LLC
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Miami, Florida, 미국, 33155
- 모병
- Bioresearch Partner
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Miami, Florida, 미국, 33143
- 모병
- Florida Pharmaceutical Research and Associates, Inc.
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Miami, Florida, 미국, 33173
- 모병
- Dade Research Center
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Miami, Florida, 미국, 33183
- 모병
- Vasconcello-Cohen MD Research, LLC.
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Miami Lakes, Florida, 미국, 33014
- 모병
- Riveldi and Associates
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North Lauderdale, Florida, 미국, 33068
- 모병
- Eminent Clinical Research and Associates
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Sweetwater, Florida, 미국, 33182
- 모병
- Cordova Research Institute LLC
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Tampa, Florida, 미국, 33617
- 모병
- Children's Health Center
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Georgia
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Chamblee, Georgia, 미국, 30341
- 아직 모집하지 않음
- ObjectiveHealth Clinical Research LLC - Chamblee
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Norcross, Georgia, 미국, 30093
- 모병
- Altruistic Clinical Research Global
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Idaho
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Ammon, Idaho, 미국, 83406
- 모병
- Medical Research Partners
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Blackfoot, Idaho, 미국, 83221
- 모병
- Bingham Memorial Hospital
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Boise, Idaho, 미국, 83702
- 모병
- ASR, LLC
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Idaho Falls, Idaho, 미국, 83404
- 모병
- Leavitt Clinical Research
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Illinois
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Moline, Illinois, 미국, 61265
- 모병
- MidValley Research, Inc
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Iowa
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Ankeny, Iowa, 미국, 50023
- 모병
- The Iowa Clinic.
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West Des Moines, Iowa, 미국, 50265
- 모병
- Eximia Research - IA, LLC (dba Integrated Clinical Trial Services, LLC)
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Kansas
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Derby, Kansas, 미국, 67037
- 모병
- Integrity Clinical Network, LLC
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Louisiana
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Haughton, Louisiana, 미국, 71037
- 모병
- ACC Pediatric Research
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Maryland
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Baltimore, Maryland, 미국, 21201
- 아직 모집하지 않음
- University of Maryland, Baltimore, Center for Vaccine Development and Global Health
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Columbia, Maryland, 미국, 21045
- 아직 모집하지 않음
- The Pediatric Center
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Columbia, Maryland, 미국, 21045
- 모병
- Kur Research, LLC
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Michigan
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Allen Park, Michigan, 미국, 48101
- 모병
- Michigan Institute of Research
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Bingham Farms, Michigan, 미국, 48025
- 모병
- Michigan Center of Medical Research
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Dearborn Heights, Michigan, 미국, 48127
- 모병
- Vida Clinical Studies, LLC
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Missouri
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Columbia, Missouri, 미국, 65212
- 모병
- University of Missouri
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Columbia, Missouri, 미국, 65201
- 모병
- University of Missouri Pediatrics Clinic-South Providence
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Nebraska
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Grand Island, Nebraska, 미국, 68803
- 모병
- Velocity Clinical Research, Grand Island
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Lincoln, Nebraska, 미국, 68504
- 모병
- Midwest Children's Health Research Institute
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Lincoln, Nebraska, 미국, 68505
- 모병
- Midwest Children's Health Research Institute
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Lincoln, Nebraska, 미국, 68516
- 모병
- Midwest Children's Health Research Institute
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Lincoln, Nebraska, 미국, 68522
- 모병
- Midwest Children's Health Research Institute
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New York
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East Syracuse, New York, 미국, 13057
- 모병
- Child Health Care Associates
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Rochester, New York, 미국, 14642
- 모병
- University of Rochester Medical Center
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North Carolina
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Charlotte, North Carolina, 미국, 28203
- 모병
- Atrium Health Cannon Research Cente
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Charlotte, North Carolina, 미국, 28207
- 모병
- Atrium Health - STRIVE Research clinic
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Charlotte, North Carolina, 미국, 28207
- 모병
- Atrium Health Levine Children's Myers Park Pediatrics
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Durham, North Carolina, 미국, 27703
- 모병
- Duke Vaccine and Trials Unit
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Durham, North Carolina, 미국, 27704
- 모병
- Durham Pediatrics at North Duke Street
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Matthews, North Carolina, 미국, 28105
- 모병
- Atrium Health Levine Children's Charlotte Pediatrics
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Matthews, North Carolina, 미국, 28105
- 모병
- Atrium Health STRIVE Research Clinic - Matthews
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Wilmington, North Carolina, 미국, 28405
- 모병
- Wilmington Health
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Ohio
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Cincinnati, Ohio, 미국, 45245
- 모병
- Pediatric Associates of Mt. Carmel
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Dayton, Ohio, 미국, 45429
- 모병
- PriMed Clinical Research
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South Euclid, Ohio, 미국, 44121
- 모병
- Senders Pediatrics
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Pennsylvania
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Bellevue, Pennsylvania, 미국, 15202
- 모병
- UPMC Children's Community Pediatrics- Bellevue
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Cranberry Township, Pennsylvania, 미국, 16066
- 모병
- UPMC Children's Community Pediatrics Bass Wolfson-Cranberry
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Erie, Pennsylvania, 미국, 16506
- 모병
- Allegheny Health and Wellness Pavilion
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Jefferson Hills, Pennsylvania, 미국, 15025
- 모병
- UPMC Children's Community Pediatrics South Hills-Jefferson Hills
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N. Huntingdon, Pennsylvania, 미국, 15642
- 모병
- UPMC Children's Community Pediatrics - Norwin
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Pittsburgh, Pennsylvania, 미국, 15217
- 모병
- UPMC Children's Community Pediatrics Bass Wolfson-Squirrel Hill
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Pittsburgh, Pennsylvania, 미국, 15234
- 모병
- UPMC Children's Community Pediatrics-Castle Shannon
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Pittsburgh, Pennsylvania, 미국, 15213
- 모병
- UPMC Children's Hospital of Pittsburgh Primary Care Center-Oakland
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Pittsburgh, Pennsylvania, 미국, 15227
- 모병
- UPMC Children's Community Pediatrics-Brentwood
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South Carolina
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Simpsonville, South Carolina, 미국, 29680
- 모병
- Tribe Clinical Research LLC. at Parkside Pediatrics Harrison Bridge Road
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Summerville, South Carolina, 미국, 29486
- 모병
- Carolina Family Care
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Summerville, South Carolina, 미국, 29486
- 모병
- MUSC Children's Health
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Tennessee
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Memphis, Tennessee, 미국, 38105
- 아직 모집하지 않음
- Le Bonheur Children's Hospital - Outpatient Building
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Tullahoma, Tennessee, 미국, 37388
- 모병
- Pediatric Clinical Trials of Tennessee, LLC
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Texas
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Brownsville, Texas, 미국, 78520
- 모병
- Proactive RGV
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Corpus Christi, Texas, 미국, 78404
- 아직 모집하지 않음
- South Texas Clinical Research
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Edinburg, Texas, 미국, 78539
- 모병
- Proactive Clinical Research LLC
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El Paso, Texas, 미국, 79902
- 모병
- Proactive El Paso,LLC
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Forney, Texas, 미국, 75126
- 모병
- SMS Clinical Research LLC.
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Galveston, Texas, 미국, 77555
- 모병
- University of Texas Medical Branch, Sealy Institute for Vaccine Sciences Clinical Trials Program
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Houston, Texas, 미국, 77065
- 모병
- Kool Kids Pediatrics
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Houston, Texas, 미국, 77090
- 모병
- Houston Clinical Research Associates
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Houston, Texas, 미국, 77054
- 모병
- Mercury Clinical Research (Administrative Office)
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Houston, Texas, 미국, 77077
- 모병
- Mercury Clinical Research - Sunrise Pediatrics
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Houston, Texas, 미국, 77042
- 모병
- Neutra Life Sciences
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Houston, Texas, 미국, 77087
- 모병
- Mercury Clinical Research - MD Kids Pediatrics
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Houston, Texas, 미국, 77057
- 아직 모집하지 않음
- UDL Clinical Research, LLC.
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Houston, Texas, 미국, 77074
- 모병
- Aavon Clinical Trials, LLC.
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Houston, Texas, 미국, 77074
- 모병
- RTX Clinical Research
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Lewisville, Texas, 미국, 75067
- 모병
- Prime Clinical Research - Lewisville
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Mansfield, Texas, 미국, 76063
- 모병
- Prime Clinical Research - Mansfield
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McAllen, Texas, 미국, 78504
- 모병
- Dr. Ruben Aleman & Associates
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Mesquite, Texas, 미국, 75149
- 모병
- SMS Clinical Research LLC
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Mesquite, Texas, 미국, 75150
- 모병
- SMS Clinical Research LLC
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Richmond, Texas, 미국, 77469
- 모병
- Pediatric Center- Neutra Life Sciences
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San Antonio, Texas, 미국, 78215
- 모병
- Sun Research Institute
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Victoria, Texas, 미국, 77901
- 아직 모집하지 않음
- Crossroads Clinical Research
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Utah
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Provo, Utah, 미국, 84604
- 모병
- AMR Clinical
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Syracuse, Utah, 미국, 84075
- 모병
- AMR Clinical
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Virginia
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Richmond, Virginia, 미국, 23226
- 모병
- Clinical Research Partners, LLC
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Richmond, Virginia, 미국, 23233
- 모병
- Tekton Research, LLC.
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Wisconsin
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Marshfield, Wisconsin, 미국, 54449
- 모병
- Marshfield Medical Center - Marshfield
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-
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-
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Fukui, 일본, 910-0833
- 모병
- Fukui Aiiku Hospital
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Fukuoka, 일본, 813-0036
- 모병
- Fukazawa Pediatric Clinic
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Osaka, 일본, 544-0033
- 모병
- Kubota Children's Clinic
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Aichi-ken
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Toyota-shi, Aichi-ken, 일본, 471-8513
- 모병
- Toyota Memorial Hospital
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Fukuoka
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Fukuoka, Fukuoka, 일본, 814-0121
- 모병
- Shindo children's clinic
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Kasuga, Fukuoka, 일본, 816-0801
- 모병
- Yokoyama Children'S Clinic
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Hokkaido
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Sapporo, Hokkaido, 일본, 062-0907
- 모병
- Ohigesenseino Kodomo Clinic
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Kagoshima-ken
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Hioki, Kagoshima-ken, 일본, 899-2503
- 모병
- Nintenkaikagoshima Children's Hospital
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Tokyo
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Shinjuku-ku, Tokyo, 일본, 160-0017
- 모병
- Futaba Clinic
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Yamanashi
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Kofu, Yamanashi, 일본, 400-0853
- 모병
- Kose Children Clinic
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-
-
-
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Bayamón, 푸에르토 리코, 00960
- 모병
- Clinical Research Investigator Group
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Caguas, 푸에르토 리코, 00726
- 모병
- San Juan Bautista School of Medicine - Clinical Research Unit
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Caguas, 푸에르토 리코, 00725
- 모병
- Caguas Clinical Research
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Guayama, 푸에르토 리코, 00784
- 모병
- Clinical Research Puerto Rico
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Ponce, 푸에르토 리코, 00716
- 모병
- Ponce Medical School Foundation Inc./ CAIMED Center
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Ponce, 푸에르토 리코, 00728
- 모병
- BRCR Global Puerto Rico
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San Juan, 푸에르토 리코, 00907
- 모병
- BRCR Global Puerto Rico
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Trujillo Alto, 푸에르토 리코, 00976-3910
- 모병
- San Miguel Medical
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
예
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Group 1 PG4 (intramuscular)
Multivalent Pneumococcal Vaccine
|
Multivalent Pneumococcal Vaccine
|
|
활성 비교기: Group 1 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)
20-valent pneumococcal conjugate vaccine (20vPnC)
|
20가 폐렴구균 결합백신(20vPnC)
다른 이름들:
|
|
실험적: Group 2 PG4 (intramuscular)
Multivalent Pneumococcal Vaccine
|
Multivalent Pneumococcal Vaccine
|
|
활성 비교기: Group 2 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)
20-valent pneumococcal conjugate vaccine (20vPnC)
|
20가 폐렴구균 결합백신(20vPnC)
다른 이름들:
|
|
실험적: Group 3 PG4 (intramuscular)
Multivalent Pneumococcal Vaccine
|
Multivalent Pneumococcal Vaccine
|
|
실험적: Group 3 PG4 (subcutaneous)
Multivalent Pneumococcal Vaccine
|
Multivalent Pneumococcal Vaccine
|
|
활성 비교기: Group 3 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)
20-valent pneumococcal conjugate vaccine (20vPnC)
|
20가 폐렴구균 결합백신(20vPnC)
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
각 투여 후 7일 이내에 국소 반응을 보고한 참가자의 비율
기간: 7일차
|
각 투여 후 국소 반응이 나타났습니다.
|
7일차
|
|
심각한 부작용(SAE)을 보고한 참가자의 비율
기간: 4차 접종 후 1~6개월간 접종
|
1차 접종부터 4차 접종 후 6개월까지 발생한 SAE
|
4차 접종 후 1~6개월간 접종
|
|
Percentage of participants reporting systemic events within 7 days after each dose
기간: 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
기간: 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
기간: 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
기간: 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
기간: 1 month after Dose 4
|
Pneumococcal IgG GMCs 1 month after Dose 4
|
1 month after Dose 4
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pneumococcal IgG GMCs 1 month after Dose 3
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Prior to Dose 4
|
Pneumococcal OPA titers prior to Dose 4
|
Prior to Dose 4
|
|
Pneumococcal OPA titers 1 month after Dose 4
기간: 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
기간: 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
기간: 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
기간: Prior to Dose 4
|
Pneumococcal IgG concentrations prior to Dose 4
|
Prior to Dose 4
|
|
Pneumococcal IgG concentrations 1 month after Dose 4
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 1 month after Dose 3
|
Geometric mean of IgA antibody levels to rotavirus 1 month after Dose 3
|
1 month after Dose 3
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 연구 책임자: Pfizer CT.gov Call Center, Pfizer
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 5월 29일
기본 완료 (추정된)
2029년 6월 5일
연구 완료 (추정된)
2029년 6월 5일
연구 등록 날짜
최초 제출
2026년 5월 27일
QC 기준을 충족하는 최초 제출
2026년 6월 4일
처음 게시됨 (실제)
2026년 6월 5일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 8일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 4일
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- C4931008
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .