A Study to Learn About How a New Pneumococcal Vaccine Works in Infants.
4. september 2026 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
3230
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
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Alabama
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Bessemer, Alabama, Forenede Stater, 35022
- Ikke rekrutterer endnu
- Kur Research, LLC
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Birmingham, Alabama, Forenede Stater, 35233
- Rekruttering
- University of Alabama at Birmingham - School of Medicine
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Birmingham, Alabama, Forenede Stater, 35205
- Rekruttering
- Alabama Clinical Therapeutics, LLC Birmingham Pediatric Associates
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Centreville, Alabama, Forenede Stater, 35042
- Ikke rekrutterer endnu
- Kur Research, LLC
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Arkansas
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Fayetteville, Arkansas, Forenede Stater, 72703
- Rekruttering
- Northwest Arkansas Pediatric Clinic
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Jonesboro, Arkansas, Forenede Stater, 72401
- Rekruttering
- The Children's Clinic of Jonesboro, P.A.
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Sherwood, Arkansas, Forenede Stater, 72120
- Rekruttering
- Helios Clinical Research
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California
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Anaheim, California, Forenede Stater, 92805
- Rekruttering
- Advanced Research Center, Inc.
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Arcadia, California, Forenede Stater, 91007
- Rekruttering
- San Gabriel Woman's Health
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Bellflower, California, Forenede Stater, 90706
- Rekruttering
- Coast Clinical Research, LLC
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El Monte, California, Forenede Stater, 91731
- Rekruttering
- Family Medical Clinic
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Fresno, California, Forenede Stater, 93704
- Rekruttering
- Clinical Research of Central California
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Montebello, California, Forenede Stater, 90640
- Rekruttering
- SeraCollection Research Services, LLC
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National City, California, Forenede Stater, 91950
- Rekruttering
- Bailony Pediatrics
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Palo Alto, California, Forenede Stater, 94304
- Ikke rekrutterer endnu
- Stanford University Medical Center
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
- Rekruttering
- Childrens Hospital of Colorado
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Florida
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Hialeah, Florida, Forenede Stater, 33012
- Rekruttering
- Direct Helpers Research Center
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Homestead, Florida, Forenede Stater, 33030
- Rekruttering
- C & R Research Services USA
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Miami, Florida, Forenede Stater, 33155
- Rekruttering
- Gold Coast Health Research Center, LLC
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Miami, Florida, Forenede Stater, 33155
- Rekruttering
- Bioresearch Partner
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Miami, Florida, Forenede Stater, 33143
- Rekruttering
- Florida Pharmaceutical Research and Associates, Inc.
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Miami, Florida, Forenede Stater, 33173
- Rekruttering
- Dade Research Center
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Miami, Florida, Forenede Stater, 33183
- Rekruttering
- Vasconcello-Cohen MD Research, LLC.
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Miami Lakes, Florida, Forenede Stater, 33014
- Rekruttering
- Riveldi and Associates
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North Lauderdale, Florida, Forenede Stater, 33068
- Rekruttering
- Eminent Clinical Research and Associates
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Sweetwater, Florida, Forenede Stater, 33182
- Rekruttering
- Cordova Research Institute LLC
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Tampa, Florida, Forenede Stater, 33617
- Rekruttering
- Children's Health Center
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Georgia
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Chamblee, Georgia, Forenede Stater, 30341
- Ikke rekrutterer endnu
- ObjectiveHealth Clinical Research LLC - Chamblee
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Norcross, Georgia, Forenede Stater, 30093
- Rekruttering
- Altruistic Clinical Research Global
-
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Idaho
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Ammon, Idaho, Forenede Stater, 83406
- Rekruttering
- Medical Research Partners
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Blackfoot, Idaho, Forenede Stater, 83221
- Rekruttering
- Bingham Memorial Hospital
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Boise, Idaho, Forenede Stater, 83702
- Rekruttering
- ASR, LLC
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Idaho Falls, Idaho, Forenede Stater, 83404
- Rekruttering
- Leavitt Clinical Research
-
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Illinois
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Moline, Illinois, Forenede Stater, 61265
- Rekruttering
- MidValley Research, Inc
-
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Iowa
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Ankeny, Iowa, Forenede Stater, 50023
- Rekruttering
- The Iowa Clinic.
-
West Des Moines, Iowa, Forenede Stater, 50265
- Rekruttering
- Eximia Research - IA, LLC (dba Integrated Clinical Trial Services, LLC)
-
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Kansas
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Derby, Kansas, Forenede Stater, 67037
- Rekruttering
- Integrity Clinical Network, LLC
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Louisiana
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Haughton, Louisiana, Forenede Stater, 71037
- Rekruttering
- ACC Pediatric Research
-
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Maryland
-
Baltimore, Maryland, Forenede Stater, 21201
- Ikke rekrutterer endnu
- University of Maryland, Baltimore, Center for Vaccine Development and Global Health
-
Columbia, Maryland, Forenede Stater, 21045
- Ikke rekrutterer endnu
- The Pediatric Center
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Columbia, Maryland, Forenede Stater, 21045
- Rekruttering
- Kur Research, LLC
-
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Michigan
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Allen Park, Michigan, Forenede Stater, 48101
- Rekruttering
- Michigan Institute of Research
-
Bingham Farms, Michigan, Forenede Stater, 48025
- Rekruttering
- Michigan Center of Medical Research
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Dearborn Heights, Michigan, Forenede Stater, 48127
- Rekruttering
- Vida Clinical Studies, LLC
-
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Missouri
-
Columbia, Missouri, Forenede Stater, 65212
- Rekruttering
- University of Missouri
-
Columbia, Missouri, Forenede Stater, 65201
- Rekruttering
- University of Missouri Pediatrics Clinic-South Providence
-
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Nebraska
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Grand Island, Nebraska, Forenede Stater, 68803
- Rekruttering
- Velocity Clinical Research, Grand Island
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Lincoln, Nebraska, Forenede Stater, 68504
- Rekruttering
- Midwest Children's Health Research Institute
-
Lincoln, Nebraska, Forenede Stater, 68505
- Rekruttering
- Midwest Children's Health Research Institute
-
Lincoln, Nebraska, Forenede Stater, 68516
- Rekruttering
- Midwest Children's Health Research Institute
-
Lincoln, Nebraska, Forenede Stater, 68522
- Rekruttering
- Midwest Children's Health Research Institute
-
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New York
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East Syracuse, New York, Forenede Stater, 13057
- Rekruttering
- Child Health Care Associates
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Rochester, New York, Forenede Stater, 14642
- Rekruttering
- University of Rochester Medical Center
-
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North Carolina
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Charlotte, North Carolina, Forenede Stater, 28203
- Rekruttering
- Atrium Health Cannon Research Cente
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Charlotte, North Carolina, Forenede Stater, 28207
- Rekruttering
- Atrium Health - STRIVE Research clinic
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Charlotte, North Carolina, Forenede Stater, 28207
- Rekruttering
- Atrium Health Levine Children's Myers Park Pediatrics
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Durham, North Carolina, Forenede Stater, 27703
- Rekruttering
- Duke Vaccine and Trials Unit
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Durham, North Carolina, Forenede Stater, 27704
- Rekruttering
- Durham Pediatrics at North Duke Street
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Matthews, North Carolina, Forenede Stater, 28105
- Rekruttering
- Atrium Health Levine Children's Charlotte Pediatrics
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Matthews, North Carolina, Forenede Stater, 28105
- Rekruttering
- Atrium Health STRIVE Research Clinic - Matthews
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Wilmington, North Carolina, Forenede Stater, 28405
- Rekruttering
- Wilmington Health
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45245
- Rekruttering
- Pediatric Associates of Mt. Carmel
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Dayton, Ohio, Forenede Stater, 45429
- Rekruttering
- PriMed Clinical Research
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South Euclid, Ohio, Forenede Stater, 44121
- Rekruttering
- Senders Pediatrics
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Pennsylvania
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Bellevue, Pennsylvania, Forenede Stater, 15202
- Rekruttering
- UPMC Children's Community Pediatrics- Bellevue
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Cranberry Township, Pennsylvania, Forenede Stater, 16066
- Rekruttering
- UPMC Children's Community Pediatrics Bass Wolfson-Cranberry
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Erie, Pennsylvania, Forenede Stater, 16506
- Rekruttering
- Allegheny Health and Wellness Pavilion
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Jefferson Hills, Pennsylvania, Forenede Stater, 15025
- Rekruttering
- UPMC Children's Community Pediatrics South Hills-Jefferson Hills
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N. Huntingdon, Pennsylvania, Forenede Stater, 15642
- Rekruttering
- UPMC Children's Community Pediatrics - Norwin
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Pittsburgh, Pennsylvania, Forenede Stater, 15217
- Rekruttering
- UPMC Children's Community Pediatrics Bass Wolfson-Squirrel Hill
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Pittsburgh, Pennsylvania, Forenede Stater, 15234
- Rekruttering
- UPMC Children's Community Pediatrics-Castle Shannon
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Pittsburgh, Pennsylvania, Forenede Stater, 15213
- Rekruttering
- UPMC Children's Hospital of Pittsburgh Primary Care Center-Oakland
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Pittsburgh, Pennsylvania, Forenede Stater, 15227
- Rekruttering
- UPMC Children's Community Pediatrics-Brentwood
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South Carolina
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Simpsonville, South Carolina, Forenede Stater, 29680
- Rekruttering
- Tribe Clinical Research LLC. at Parkside Pediatrics Harrison Bridge Road
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Summerville, South Carolina, Forenede Stater, 29486
- Rekruttering
- Carolina Family Care
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Summerville, South Carolina, Forenede Stater, 29486
- Rekruttering
- MUSC Children's Health
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Tennessee
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Memphis, Tennessee, Forenede Stater, 38105
- Ikke rekrutterer endnu
- Le Bonheur Children's Hospital - Outpatient Building
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Tullahoma, Tennessee, Forenede Stater, 37388
- Rekruttering
- Pediatric Clinical Trials of Tennessee, LLC
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Texas
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Brownsville, Texas, Forenede Stater, 78520
- Rekruttering
- Proactive RGV
-
Corpus Christi, Texas, Forenede Stater, 78404
- Ikke rekrutterer endnu
- South Texas Clinical Research
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Edinburg, Texas, Forenede Stater, 78539
- Rekruttering
- Proactive Clinical Research LLC
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El Paso, Texas, Forenede Stater, 79902
- Rekruttering
- Proactive El Paso,LLC
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Forney, Texas, Forenede Stater, 75126
- Rekruttering
- SMS Clinical Research LLC.
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Galveston, Texas, Forenede Stater, 77555
- Rekruttering
- University of Texas Medical Branch, Sealy Institute for Vaccine Sciences Clinical Trials Program
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Houston, Texas, Forenede Stater, 77065
- Rekruttering
- Kool Kids Pediatrics
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Houston, Texas, Forenede Stater, 77090
- Rekruttering
- Houston Clinical Research Associates
-
Houston, Texas, Forenede Stater, 77054
- Rekruttering
- Mercury Clinical Research (Administrative Office)
-
Houston, Texas, Forenede Stater, 77077
- Rekruttering
- Mercury Clinical Research - Sunrise Pediatrics
-
Houston, Texas, Forenede Stater, 77042
- Rekruttering
- Neutra Life Sciences
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Houston, Texas, Forenede Stater, 77087
- Rekruttering
- Mercury Clinical Research - MD Kids Pediatrics
-
Houston, Texas, Forenede Stater, 77057
- Ikke rekrutterer endnu
- UDL Clinical Research, LLC.
-
Houston, Texas, Forenede Stater, 77074
- Rekruttering
- Aavon Clinical Trials, LLC.
-
Houston, Texas, Forenede Stater, 77074
- Rekruttering
- RTX Clinical Research
-
Lewisville, Texas, Forenede Stater, 75067
- Rekruttering
- Prime Clinical Research - Lewisville
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Mansfield, Texas, Forenede Stater, 76063
- Rekruttering
- Prime Clinical Research - Mansfield
-
McAllen, Texas, Forenede Stater, 78504
- Rekruttering
- Dr. Ruben Aleman & Associates
-
Mesquite, Texas, Forenede Stater, 75149
- Rekruttering
- SMS Clinical Research LLC
-
Mesquite, Texas, Forenede Stater, 75150
- Rekruttering
- SMS Clinical Research LLC
-
Richmond, Texas, Forenede Stater, 77469
- Rekruttering
- Pediatric Center- Neutra Life Sciences
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San Antonio, Texas, Forenede Stater, 78215
- Rekruttering
- Sun Research Institute
-
Victoria, Texas, Forenede Stater, 77901
- Ikke rekrutterer endnu
- Crossroads Clinical Research
-
-
Utah
-
Provo, Utah, Forenede Stater, 84604
- Rekruttering
- AMR Clinical
-
Syracuse, Utah, Forenede Stater, 84075
- Rekruttering
- AMR Clinical
-
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Virginia
-
Richmond, Virginia, Forenede Stater, 23226
- Rekruttering
- Clinical Research Partners, LLC
-
Richmond, Virginia, Forenede Stater, 23233
- Rekruttering
- Tekton Research, LLC.
-
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Wisconsin
-
Marshfield, Wisconsin, Forenede Stater, 54449
- Rekruttering
- Marshfield Medical Center - Marshfield
-
-
-
-
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Fukui, Japan, 910-0833
- Rekruttering
- Fukui Aiiku Hospital
-
Fukuoka, Japan, 813-0036
- Rekruttering
- Fukazawa Pediatric Clinic
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Osaka, Japan, 544-0033
- Rekruttering
- Kubota Children's Clinic
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Aichi-ken
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Toyota-shi, Aichi-ken, Japan, 471-8513
- Rekruttering
- Toyota Memorial Hospital
-
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Fukuoka
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Fukuoka, Fukuoka, Japan, 814-0121
- Rekruttering
- Shindo children's clinic
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Kasuga, Fukuoka, Japan, 816-0801
- Rekruttering
- Yokoyama Children'S Clinic
-
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Hokkaido
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Sapporo, Hokkaido, Japan, 062-0907
- Rekruttering
- Ohigesenseino Kodomo Clinic
-
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Kagoshima-ken
-
Hioki, Kagoshima-ken, Japan, 899-2503
- Rekruttering
- Nintenkaikagoshima Children's Hospital
-
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Tokyo
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Shinjuku-ku, Tokyo, Japan, 160-0017
- Rekruttering
- Futaba Clinic
-
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Yamanashi
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Kofu, Yamanashi, Japan, 400-0853
- Rekruttering
- Kose Children Clinic
-
-
-
-
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Bayamón, Puerto Rico, 00960
- Rekruttering
- Clinical Research Investigator Group
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Caguas, Puerto Rico, 00726
- Rekruttering
- San Juan Bautista School of Medicine - Clinical Research Unit
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Caguas, Puerto Rico, 00725
- Rekruttering
- Caguas Clinical Research
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Guayama, Puerto Rico, 00784
- Rekruttering
- Clinical Research Puerto Rico
-
Ponce, Puerto Rico, 00716
- Rekruttering
- Ponce Medical School Foundation Inc./ CAIMED Center
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Ponce, Puerto Rico, 00728
- Rekruttering
- BRCR Global Puerto Rico
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San Juan, Puerto Rico, 00907
- Rekruttering
- BRCR Global Puerto Rico
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Trujillo Alto, Puerto Rico, 00976-3910
- Rekruttering
- San Miguel Medical
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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 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.
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: Group 1 PG4 (intramuscular)
Multivalent Pneumococcal Vaccine
|
Multivalent Pneumococcal Vaccine
|
|
Aktiv komparator: Group 1 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)
20-valent pneumococcal conjugate vaccine (20vPnC)
|
20-valent pneumokokkonjugatvaccine (20vPnC)
Andre navne:
|
|
Eksperimentel: Group 2 PG4 (intramuscular)
Multivalent Pneumococcal Vaccine
|
Multivalent Pneumococcal Vaccine
|
|
Aktiv komparator: Group 2 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)
20-valent pneumococcal conjugate vaccine (20vPnC)
|
20-valent pneumokokkonjugatvaccine (20vPnC)
Andre navne:
|
|
Eksperimentel: Group 3 PG4 (intramuscular)
Multivalent Pneumococcal Vaccine
|
Multivalent Pneumococcal Vaccine
|
|
Eksperimentel: Group 3 PG4 (subcutaneous)
Multivalent Pneumococcal Vaccine
|
Multivalent Pneumococcal Vaccine
|
|
Aktiv komparator: Group 3 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
|
|
Differences in percentages of participants with predefined pneumococcal specific immunoglobulin G (IgG) concentrations 1 month after Dose 3
Tidsramme: 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
Tidsramme: 1 month after Dose 4
|
Pneumococcal IgG GMCs 1 month after Dose 4
|
1 month after Dose 4
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pneumococcal IgG GMCs 1 month after Dose 3
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Prior to Dose 4
|
Pneumococcal OPA titers prior to Dose 4
|
Prior to Dose 4
|
|
Pneumococcal OPA titers 1 month after Dose 4
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Prior to Dose 4
|
Pneumococcal IgG concentrations prior to Dose 4
|
Prior to Dose 4
|
|
Pneumococcal IgG concentrations 1 month after Dose 4
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 1 month after Dose 3
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Prespecified antibody levels to specific concomitant vaccine antigens 1 month after Dose 3
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1 month after Dose 3
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Geometric mean of antibody levels to measles, mumps, rubella, varicella, and hepatitis A virus antigens 1 month after Dose 4
Tidsramme: 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
|
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Geometric mean of immunoglobulin A (IgA) antibody levels to rotavirus 1 month after Dose 3
Tidsramme: 1 month after Dose 3
|
Geometric mean of IgA antibody levels to rotavirus 1 month after Dose 3
|
1 month after Dose 3
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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)
29. maj 2026
Primær færdiggørelse (Anslået)
5. juni 2029
Studieafslutning (Anslået)
5. juni 2029
Datoer for studieregistrering
Først indsendt
27. maj 2026
Først indsendt, der opfyldte QC-kriterier
4. juni 2026
Først opslået (Faktiske)
5. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
8. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- C4931008
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 .