A Study to Learn About How a New Pneumococcal Vaccine Works in Infants.
4. september 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
3230
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Pfizer CT.gov Call Center
- Telefonnummer: 1-800-718-1021
- E-post: ClinicalTrials.gov_Inquiries@pfizer.com
Studiesteder
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Alabama
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Bessemer, Alabama, Forente stater, 35022
- Har ikke rekruttert ennå
- Kur Research, LLC
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Birmingham, Alabama, Forente stater, 35233
- Rekruttering
- University of Alabama at Birmingham - School of Medicine
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Birmingham, Alabama, Forente stater, 35205
- Rekruttering
- Alabama Clinical Therapeutics, LLC Birmingham Pediatric Associates
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Centreville, Alabama, Forente stater, 35042
- Har ikke rekruttert ennå
- Kur Research, LLC
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Arkansas
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Fayetteville, Arkansas, Forente stater, 72703
- Rekruttering
- Northwest Arkansas Pediatric Clinic
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Jonesboro, Arkansas, Forente stater, 72401
- Rekruttering
- The Children's Clinic of Jonesboro, P.A.
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Sherwood, Arkansas, Forente stater, 72120
- Rekruttering
- Helios Clinical Research
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California
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Anaheim, California, Forente stater, 92805
- Rekruttering
- Advanced Research Center, Inc.
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Arcadia, California, Forente stater, 91007
- Rekruttering
- San Gabriel Woman's Health
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Bellflower, California, Forente stater, 90706
- Rekruttering
- Coast Clinical Research, LLC
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El Monte, California, Forente stater, 91731
- Rekruttering
- Family Medical Clinic
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Fresno, California, Forente stater, 93704
- Rekruttering
- Clinical Research of Central California
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Montebello, California, Forente stater, 90640
- Rekruttering
- SeraCollection Research Services, LLC
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National City, California, Forente stater, 91950
- Rekruttering
- Bailony Pediatrics
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Palo Alto, California, Forente stater, 94304
- Har ikke rekruttert ennå
- Stanford University Medical Center
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Colorado
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Aurora, Colorado, Forente stater, 80045
- Rekruttering
- Childrens Hospital of Colorado
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Florida
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Hialeah, Florida, Forente stater, 33012
- Rekruttering
- Direct Helpers Research Center
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Homestead, Florida, Forente stater, 33030
- Rekruttering
- C & R Research Services USA
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Miami, Florida, Forente stater, 33155
- Rekruttering
- Gold Coast Health Research Center, LLC
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Miami, Florida, Forente stater, 33155
- Rekruttering
- Bioresearch Partner
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Miami, Florida, Forente stater, 33143
- Rekruttering
- Florida Pharmaceutical Research and Associates, Inc.
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Miami, Florida, Forente stater, 33173
- Rekruttering
- Dade Research Center
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Miami, Florida, Forente stater, 33183
- Rekruttering
- Vasconcello-Cohen MD Research, LLC.
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Miami Lakes, Florida, Forente stater, 33014
- Rekruttering
- Riveldi and Associates
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North Lauderdale, Florida, Forente stater, 33068
- Rekruttering
- Eminent Clinical Research and Associates
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Sweetwater, Florida, Forente stater, 33182
- Rekruttering
- Cordova Research Institute LLC
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Tampa, Florida, Forente stater, 33617
- Rekruttering
- Children's Health Center
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Georgia
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Chamblee, Georgia, Forente stater, 30341
- Har ikke rekruttert ennå
- ObjectiveHealth Clinical Research LLC - Chamblee
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Norcross, Georgia, Forente stater, 30093
- Rekruttering
- Altruistic Clinical Research Global
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Idaho
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Ammon, Idaho, Forente stater, 83406
- Rekruttering
- Medical Research Partners
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Blackfoot, Idaho, Forente stater, 83221
- Rekruttering
- Bingham Memorial Hospital
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Boise, Idaho, Forente stater, 83702
- Rekruttering
- ASR, LLC
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Idaho Falls, Idaho, Forente stater, 83404
- Rekruttering
- Leavitt Clinical Research
-
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Illinois
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Moline, Illinois, Forente stater, 61265
- Rekruttering
- MidValley Research, Inc
-
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Iowa
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Ankeny, Iowa, Forente stater, 50023
- Rekruttering
- The Iowa Clinic.
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West Des Moines, Iowa, Forente stater, 50265
- Rekruttering
- Eximia Research - IA, LLC (dba Integrated Clinical Trial Services, LLC)
-
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Kansas
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Derby, Kansas, Forente stater, 67037
- Rekruttering
- Integrity Clinical Network, LLC
-
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Louisiana
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Haughton, Louisiana, Forente stater, 71037
- Rekruttering
- ACC Pediatric Research
-
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Maryland
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Baltimore, Maryland, Forente stater, 21201
- Har ikke rekruttert ennå
- University of Maryland, Baltimore, Center for Vaccine Development and Global Health
-
Columbia, Maryland, Forente stater, 21045
- Har ikke rekruttert ennå
- The Pediatric Center
-
Columbia, Maryland, Forente stater, 21045
- Rekruttering
- Kur Research, LLC
-
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Michigan
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Allen Park, Michigan, Forente stater, 48101
- Rekruttering
- Michigan Institute of Research
-
Bingham Farms, Michigan, Forente stater, 48025
- Rekruttering
- Michigan Center of Medical Research
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Dearborn Heights, Michigan, Forente stater, 48127
- Rekruttering
- Vida Clinical Studies, LLC
-
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Missouri
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Columbia, Missouri, Forente stater, 65212
- Rekruttering
- University of Missouri
-
Columbia, Missouri, Forente stater, 65201
- Rekruttering
- University of Missouri Pediatrics Clinic-South Providence
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Nebraska
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Grand Island, Nebraska, Forente stater, 68803
- Rekruttering
- Velocity Clinical Research, Grand Island
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Lincoln, Nebraska, Forente stater, 68504
- Rekruttering
- Midwest Children's Health Research Institute
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Lincoln, Nebraska, Forente stater, 68505
- Rekruttering
- Midwest Children's Health Research Institute
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Lincoln, Nebraska, Forente stater, 68516
- Rekruttering
- Midwest Children's Health Research Institute
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Lincoln, Nebraska, Forente stater, 68522
- Rekruttering
- Midwest Children's Health Research Institute
-
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New York
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East Syracuse, New York, Forente stater, 13057
- Rekruttering
- Child Health Care Associates
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Rochester, New York, Forente stater, 14642
- Rekruttering
- University of Rochester Medical Center
-
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North Carolina
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Charlotte, North Carolina, Forente stater, 28203
- Rekruttering
- Atrium Health Cannon Research Cente
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Charlotte, North Carolina, Forente stater, 28207
- Rekruttering
- Atrium Health - STRIVE Research clinic
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Charlotte, North Carolina, Forente stater, 28207
- Rekruttering
- Atrium Health Levine Children's Myers Park Pediatrics
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Durham, North Carolina, Forente stater, 27703
- Rekruttering
- Duke Vaccine and Trials Unit
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Durham, North Carolina, Forente stater, 27704
- Rekruttering
- Durham Pediatrics at North Duke Street
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Matthews, North Carolina, Forente stater, 28105
- Rekruttering
- Atrium Health Levine Children's Charlotte Pediatrics
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Matthews, North Carolina, Forente stater, 28105
- Rekruttering
- Atrium Health STRIVE Research Clinic - Matthews
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Wilmington, North Carolina, Forente stater, 28405
- Rekruttering
- Wilmington Health
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Ohio
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Cincinnati, Ohio, Forente stater, 45245
- Rekruttering
- Pediatric Associates of Mt. Carmel
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Dayton, Ohio, Forente stater, 45429
- Rekruttering
- PriMed Clinical Research
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South Euclid, Ohio, Forente stater, 44121
- Rekruttering
- Senders Pediatrics
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Pennsylvania
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Bellevue, Pennsylvania, Forente stater, 15202
- Rekruttering
- UPMC Children's Community Pediatrics- Bellevue
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Cranberry Township, Pennsylvania, Forente stater, 16066
- Rekruttering
- UPMC Children's Community Pediatrics Bass Wolfson-Cranberry
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Erie, Pennsylvania, Forente stater, 16506
- Rekruttering
- Allegheny Health and Wellness Pavilion
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Jefferson Hills, Pennsylvania, Forente stater, 15025
- Rekruttering
- UPMC Children's Community Pediatrics South Hills-Jefferson Hills
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N. Huntingdon, Pennsylvania, Forente stater, 15642
- Rekruttering
- UPMC Children's Community Pediatrics - Norwin
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Pittsburgh, Pennsylvania, Forente stater, 15217
- Rekruttering
- UPMC Children's Community Pediatrics Bass Wolfson-Squirrel Hill
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Pittsburgh, Pennsylvania, Forente stater, 15234
- Rekruttering
- UPMC Children's Community Pediatrics-Castle Shannon
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Pittsburgh, Pennsylvania, Forente stater, 15213
- Rekruttering
- UPMC Children's Hospital of Pittsburgh Primary Care Center-Oakland
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Pittsburgh, Pennsylvania, Forente stater, 15227
- Rekruttering
- UPMC Children's Community Pediatrics-Brentwood
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South Carolina
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Simpsonville, South Carolina, Forente stater, 29680
- Rekruttering
- Tribe Clinical Research LLC. at Parkside Pediatrics Harrison Bridge Road
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Summerville, South Carolina, Forente stater, 29486
- Rekruttering
- Carolina Family Care
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Summerville, South Carolina, Forente stater, 29486
- Rekruttering
- MUSC Children's Health
-
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Tennessee
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Memphis, Tennessee, Forente stater, 38105
- Har ikke rekruttert ennå
- Le Bonheur Children's Hospital - Outpatient Building
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Tullahoma, Tennessee, Forente stater, 37388
- Rekruttering
- Pediatric Clinical Trials of Tennessee, LLC
-
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Texas
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Brownsville, Texas, Forente stater, 78520
- Rekruttering
- Proactive RGV
-
Corpus Christi, Texas, Forente stater, 78404
- Har ikke rekruttert ennå
- South Texas Clinical Research
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Edinburg, Texas, Forente stater, 78539
- Rekruttering
- Proactive Clinical Research LLC
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El Paso, Texas, Forente stater, 79902
- Rekruttering
- Proactive El Paso,LLC
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Forney, Texas, Forente stater, 75126
- Rekruttering
- SMS Clinical Research LLC.
-
Galveston, Texas, Forente stater, 77555
- Rekruttering
- University of Texas Medical Branch, Sealy Institute for Vaccine Sciences Clinical Trials Program
-
Houston, Texas, Forente stater, 77065
- Rekruttering
- Kool Kids Pediatrics
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Houston, Texas, Forente stater, 77090
- Rekruttering
- Houston Clinical Research Associates
-
Houston, Texas, Forente stater, 77054
- Rekruttering
- Mercury Clinical Research (Administrative Office)
-
Houston, Texas, Forente stater, 77077
- Rekruttering
- Mercury Clinical Research - Sunrise Pediatrics
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Houston, Texas, Forente stater, 77042
- Rekruttering
- Neutra Life Sciences
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Houston, Texas, Forente stater, 77087
- Rekruttering
- Mercury Clinical Research - MD Kids Pediatrics
-
Houston, Texas, Forente stater, 77057
- Har ikke rekruttert ennå
- UDL Clinical Research, LLC.
-
Houston, Texas, Forente stater, 77074
- Rekruttering
- Aavon Clinical Trials, LLC.
-
Houston, Texas, Forente stater, 77074
- Rekruttering
- RTX Clinical Research
-
Lewisville, Texas, Forente stater, 75067
- Rekruttering
- Prime Clinical Research - Lewisville
-
Mansfield, Texas, Forente stater, 76063
- Rekruttering
- Prime Clinical Research - Mansfield
-
McAllen, Texas, Forente stater, 78504
- Rekruttering
- Dr. Ruben Aleman & Associates
-
Mesquite, Texas, Forente stater, 75149
- Rekruttering
- SMS Clinical Research LLC
-
Mesquite, Texas, Forente stater, 75150
- Rekruttering
- SMS Clinical Research LLC
-
Richmond, Texas, Forente stater, 77469
- Rekruttering
- Pediatric Center- Neutra Life Sciences
-
San Antonio, Texas, Forente stater, 78215
- Rekruttering
- Sun Research Institute
-
Victoria, Texas, Forente stater, 77901
- Har ikke rekruttert ennå
- Crossroads Clinical Research
-
-
Utah
-
Provo, Utah, Forente stater, 84604
- Rekruttering
- AMR Clinical
-
Syracuse, Utah, Forente stater, 84075
- Rekruttering
- AMR Clinical
-
-
Virginia
-
Richmond, Virginia, Forente stater, 23226
- Rekruttering
- Clinical Research Partners, LLC
-
Richmond, Virginia, Forente stater, 23233
- Rekruttering
- Tekton Research, LLC.
-
-
Wisconsin
-
Marshfield, Wisconsin, Forente 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
-
-
Fukuoka
-
Fukuoka, Fukuoka, Japan, 814-0121
- Rekruttering
- Shindo children's clinic
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Kasuga, Fukuoka, Japan, 816-0801
- Rekruttering
- Yokoyama Children'S Clinic
-
-
Hokkaido
-
Sapporo, Hokkaido, Japan, 062-0907
- Rekruttering
- Ohigesenseino Kodomo Clinic
-
-
Kagoshima-ken
-
Hioki, Kagoshima-ken, Japan, 899-2503
- Rekruttering
- Nintenkaikagoshima Children's Hospital
-
-
Tokyo
-
Shinjuku-ku, Tokyo, Japan, 160-0017
- Rekruttering
- Futaba Clinic
-
-
Yamanashi
-
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
-
Trujillo Alto, Puerto Rico, 00976-3910
- Rekruttering
- San Miguel Medical
-
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske 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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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 pneumokokkkonjugatvaksine (20vPnC)
Andre navn:
|
|
Eksperimentell: 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 pneumokokkkonjugatvaksine (20vPnC)
Andre navn:
|
|
Eksperimentell: Group 3 PG4 (intramuscular)
Multivalent Pneumococcal Vaccine
|
Multivalent Pneumococcal Vaccine
|
|
Eksperimentell: 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 pneumokokkkonjugatvaksine (20vPnC)
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Prosentandel av deltakerne som rapporterte lokale reaksjoner innen 7 dager etter hver dose
Tidsramme: Dag 7
|
Utløste lokale reaksjoner etter hver dose
|
Dag 7
|
|
Prosentandel av deltakerne som rapporterer alvorlige bivirkninger (SAE)
Tidsramme: Dose 1 til 6 måneder etter dose 4
|
SAE som oppstår fra dose 1 til 6 måneder etter dose 4
|
Dose 1 til 6 måneder etter dose 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 |
Tiltaksbeskrivelse |
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
|
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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Pfizer CT.gov Call Center, Pfizer
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
29. mai 2026
Primær fullføring (Antatt)
5. juni 2029
Studiet fullført (Antatt)
5. juni 2029
Datoer for studieregistrering
Først innsendt
27. mai 2026
Først innsendt som oppfylte QC-kriteriene
4. juni 2026
Først lagt ut (Faktiske)
5. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- C4931008
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .