A Study to Learn About How a New Pneumococcal Vaccine Works in Infants.
4 september 2026 uppdaterad 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
3230
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Pfizer CT.gov Call Center
- Telefonnummer: 1-800-718-1021
- E-post: ClinicalTrials.gov_Inquiries@pfizer.com
Studieorter
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Alabama
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Bessemer, Alabama, Förenta staterna, 35022
- Har inte rekryterat ännu
- Kur Research, LLC
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Birmingham, Alabama, Förenta staterna, 35233
- Rekrytering
- University of Alabama at Birmingham - School of Medicine
-
Birmingham, Alabama, Förenta staterna, 35205
- Rekrytering
- Alabama Clinical Therapeutics, LLC Birmingham Pediatric Associates
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Centreville, Alabama, Förenta staterna, 35042
- Har inte rekryterat ännu
- Kur Research, LLC
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Arkansas
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Fayetteville, Arkansas, Förenta staterna, 72703
- Rekrytering
- Northwest Arkansas Pediatric Clinic
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Jonesboro, Arkansas, Förenta staterna, 72401
- Rekrytering
- The Children's Clinic of Jonesboro, P.A.
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Sherwood, Arkansas, Förenta staterna, 72120
- Rekrytering
- Helios Clinical Research
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California
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Anaheim, California, Förenta staterna, 92805
- Rekrytering
- Advanced Research Center, Inc.
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Arcadia, California, Förenta staterna, 91007
- Rekrytering
- San Gabriel Woman's Health
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Bellflower, California, Förenta staterna, 90706
- Rekrytering
- Coast Clinical Research, LLC
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El Monte, California, Förenta staterna, 91731
- Rekrytering
- Family Medical Clinic
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Fresno, California, Förenta staterna, 93704
- Rekrytering
- Clinical Research of Central California
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Montebello, California, Förenta staterna, 90640
- Rekrytering
- SeraCollection Research Services, LLC
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National City, California, Förenta staterna, 91950
- Rekrytering
- Bailony Pediatrics
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Palo Alto, California, Förenta staterna, 94304
- Har inte rekryterat ännu
- Stanford University Medical Center
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Colorado
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Aurora, Colorado, Förenta staterna, 80045
- Rekrytering
- Childrens Hospital of Colorado
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Florida
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Hialeah, Florida, Förenta staterna, 33012
- Rekrytering
- Direct Helpers Research Center
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Homestead, Florida, Förenta staterna, 33030
- Rekrytering
- C & R Research Services USA
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Miami, Florida, Förenta staterna, 33155
- Rekrytering
- Gold Coast Health Research Center, LLC
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Miami, Florida, Förenta staterna, 33155
- Rekrytering
- Bioresearch Partner
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Miami, Florida, Förenta staterna, 33143
- Rekrytering
- Florida Pharmaceutical Research and Associates, Inc.
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Miami, Florida, Förenta staterna, 33173
- Rekrytering
- Dade Research Center
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Miami, Florida, Förenta staterna, 33183
- Rekrytering
- Vasconcello-Cohen MD Research, LLC.
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Miami Lakes, Florida, Förenta staterna, 33014
- Rekrytering
- Riveldi and Associates
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North Lauderdale, Florida, Förenta staterna, 33068
- Rekrytering
- Eminent Clinical Research and Associates
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Sweetwater, Florida, Förenta staterna, 33182
- Rekrytering
- Cordova Research Institute LLC
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Tampa, Florida, Förenta staterna, 33617
- Rekrytering
- Children's Health Center
-
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Georgia
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Chamblee, Georgia, Förenta staterna, 30341
- Har inte rekryterat ännu
- ObjectiveHealth Clinical Research LLC - Chamblee
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Norcross, Georgia, Förenta staterna, 30093
- Rekrytering
- Altruistic Clinical Research Global
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Idaho
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Ammon, Idaho, Förenta staterna, 83406
- Rekrytering
- Medical Research Partners
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Blackfoot, Idaho, Förenta staterna, 83221
- Rekrytering
- Bingham Memorial Hospital
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Boise, Idaho, Förenta staterna, 83702
- Rekrytering
- ASR, LLC
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Idaho Falls, Idaho, Förenta staterna, 83404
- Rekrytering
- Leavitt Clinical Research
-
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Illinois
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Moline, Illinois, Förenta staterna, 61265
- Rekrytering
- MidValley Research, Inc
-
-
Iowa
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Ankeny, Iowa, Förenta staterna, 50023
- Rekrytering
- The Iowa Clinic.
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West Des Moines, Iowa, Förenta staterna, 50265
- Rekrytering
- Eximia Research - IA, LLC (dba Integrated Clinical Trial Services, LLC)
-
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Kansas
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Derby, Kansas, Förenta staterna, 67037
- Rekrytering
- Integrity Clinical Network, LLC
-
-
Louisiana
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Haughton, Louisiana, Förenta staterna, 71037
- Rekrytering
- ACC Pediatric Research
-
-
Maryland
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Baltimore, Maryland, Förenta staterna, 21201
- Har inte rekryterat ännu
- University of Maryland, Baltimore, Center for Vaccine Development and Global Health
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Columbia, Maryland, Förenta staterna, 21045
- Har inte rekryterat ännu
- The Pediatric Center
-
Columbia, Maryland, Förenta staterna, 21045
- Rekrytering
- Kur Research, LLC
-
-
Michigan
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Allen Park, Michigan, Förenta staterna, 48101
- Rekrytering
- Michigan Institute of Research
-
Bingham Farms, Michigan, Förenta staterna, 48025
- Rekrytering
- Michigan Center of Medical Research
-
Dearborn Heights, Michigan, Förenta staterna, 48127
- Rekrytering
- Vida Clinical Studies, LLC
-
-
Missouri
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Columbia, Missouri, Förenta staterna, 65212
- Rekrytering
- University of Missouri
-
Columbia, Missouri, Förenta staterna, 65201
- Rekrytering
- University of Missouri Pediatrics Clinic-South Providence
-
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Nebraska
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Grand Island, Nebraska, Förenta staterna, 68803
- Rekrytering
- Velocity Clinical Research, Grand Island
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Lincoln, Nebraska, Förenta staterna, 68504
- Rekrytering
- Midwest Children's Health Research Institute
-
Lincoln, Nebraska, Förenta staterna, 68505
- Rekrytering
- Midwest Children's Health Research Institute
-
Lincoln, Nebraska, Förenta staterna, 68516
- Rekrytering
- Midwest Children's Health Research Institute
-
Lincoln, Nebraska, Förenta staterna, 68522
- Rekrytering
- Midwest Children's Health Research Institute
-
-
New York
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East Syracuse, New York, Förenta staterna, 13057
- Rekrytering
- Child Health Care Associates
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Rochester, New York, Förenta staterna, 14642
- Rekrytering
- University of Rochester Medical Center
-
-
North Carolina
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Charlotte, North Carolina, Förenta staterna, 28203
- Rekrytering
- Atrium Health Cannon Research Cente
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Charlotte, North Carolina, Förenta staterna, 28207
- Rekrytering
- Atrium Health - STRIVE Research clinic
-
Charlotte, North Carolina, Förenta staterna, 28207
- Rekrytering
- Atrium Health Levine Children's Myers Park Pediatrics
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Durham, North Carolina, Förenta staterna, 27703
- Rekrytering
- Duke Vaccine and Trials Unit
-
Durham, North Carolina, Förenta staterna, 27704
- Rekrytering
- Durham Pediatrics at North Duke Street
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Matthews, North Carolina, Förenta staterna, 28105
- Rekrytering
- Atrium Health Levine Children's Charlotte Pediatrics
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Matthews, North Carolina, Förenta staterna, 28105
- Rekrytering
- Atrium Health STRIVE Research Clinic - Matthews
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Wilmington, North Carolina, Förenta staterna, 28405
- Rekrytering
- Wilmington Health
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Ohio
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Cincinnati, Ohio, Förenta staterna, 45245
- Rekrytering
- Pediatric Associates of Mt. Carmel
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Dayton, Ohio, Förenta staterna, 45429
- Rekrytering
- PriMed Clinical Research
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South Euclid, Ohio, Förenta staterna, 44121
- Rekrytering
- Senders Pediatrics
-
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Pennsylvania
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Bellevue, Pennsylvania, Förenta staterna, 15202
- Rekrytering
- UPMC Children's Community Pediatrics- Bellevue
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Cranberry Township, Pennsylvania, Förenta staterna, 16066
- Rekrytering
- UPMC Children's Community Pediatrics Bass Wolfson-Cranberry
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Erie, Pennsylvania, Förenta staterna, 16506
- Rekrytering
- Allegheny Health and Wellness Pavilion
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Jefferson Hills, Pennsylvania, Förenta staterna, 15025
- Rekrytering
- UPMC Children's Community Pediatrics South Hills-Jefferson Hills
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N. Huntingdon, Pennsylvania, Förenta staterna, 15642
- Rekrytering
- UPMC Children's Community Pediatrics - Norwin
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Pittsburgh, Pennsylvania, Förenta staterna, 15217
- Rekrytering
- UPMC Children's Community Pediatrics Bass Wolfson-Squirrel Hill
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Pittsburgh, Pennsylvania, Förenta staterna, 15234
- Rekrytering
- UPMC Children's Community Pediatrics-Castle Shannon
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Pittsburgh, Pennsylvania, Förenta staterna, 15213
- Rekrytering
- UPMC Children's Hospital of Pittsburgh Primary Care Center-Oakland
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Pittsburgh, Pennsylvania, Förenta staterna, 15227
- Rekrytering
- UPMC Children's Community Pediatrics-Brentwood
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South Carolina
-
Simpsonville, South Carolina, Förenta staterna, 29680
- Rekrytering
- Tribe Clinical Research LLC. at Parkside Pediatrics Harrison Bridge Road
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Summerville, South Carolina, Förenta staterna, 29486
- Rekrytering
- Carolina Family Care
-
Summerville, South Carolina, Förenta staterna, 29486
- Rekrytering
- MUSC Children's Health
-
-
Tennessee
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Memphis, Tennessee, Förenta staterna, 38105
- Har inte rekryterat ännu
- Le Bonheur Children's Hospital - Outpatient Building
-
Tullahoma, Tennessee, Förenta staterna, 37388
- Rekrytering
- Pediatric Clinical Trials of Tennessee, LLC
-
-
Texas
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Brownsville, Texas, Förenta staterna, 78520
- Rekrytering
- Proactive RGV
-
Corpus Christi, Texas, Förenta staterna, 78404
- Har inte rekryterat ännu
- South Texas Clinical Research
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Edinburg, Texas, Förenta staterna, 78539
- Rekrytering
- Proactive Clinical Research LLC
-
El Paso, Texas, Förenta staterna, 79902
- Rekrytering
- Proactive El Paso,LLC
-
Forney, Texas, Förenta staterna, 75126
- Rekrytering
- SMS Clinical Research LLC.
-
Galveston, Texas, Förenta staterna, 77555
- Rekrytering
- University of Texas Medical Branch, Sealy Institute for Vaccine Sciences Clinical Trials Program
-
Houston, Texas, Förenta staterna, 77065
- Rekrytering
- Kool Kids Pediatrics
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Houston, Texas, Förenta staterna, 77090
- Rekrytering
- Houston Clinical Research Associates
-
Houston, Texas, Förenta staterna, 77054
- Rekrytering
- Mercury Clinical Research (Administrative Office)
-
Houston, Texas, Förenta staterna, 77077
- Rekrytering
- Mercury Clinical Research - Sunrise Pediatrics
-
Houston, Texas, Förenta staterna, 77042
- Rekrytering
- Neutra Life Sciences
-
Houston, Texas, Förenta staterna, 77087
- Rekrytering
- Mercury Clinical Research - MD Kids Pediatrics
-
Houston, Texas, Förenta staterna, 77057
- Har inte rekryterat ännu
- UDL Clinical Research, LLC.
-
Houston, Texas, Förenta staterna, 77074
- Rekrytering
- Aavon Clinical Trials, LLC.
-
Houston, Texas, Förenta staterna, 77074
- Rekrytering
- RTX Clinical Research
-
Lewisville, Texas, Förenta staterna, 75067
- Rekrytering
- Prime Clinical Research - Lewisville
-
Mansfield, Texas, Förenta staterna, 76063
- Rekrytering
- Prime Clinical Research - Mansfield
-
McAllen, Texas, Förenta staterna, 78504
- Rekrytering
- Dr. Ruben Aleman & Associates
-
Mesquite, Texas, Förenta staterna, 75149
- Rekrytering
- SMS Clinical Research LLC
-
Mesquite, Texas, Förenta staterna, 75150
- Rekrytering
- SMS Clinical Research LLC
-
Richmond, Texas, Förenta staterna, 77469
- Rekrytering
- Pediatric Center- Neutra Life Sciences
-
San Antonio, Texas, Förenta staterna, 78215
- Rekrytering
- Sun Research Institute
-
Victoria, Texas, Förenta staterna, 77901
- Har inte rekryterat ännu
- Crossroads Clinical Research
-
-
Utah
-
Provo, Utah, Förenta staterna, 84604
- Rekrytering
- AMR Clinical
-
Syracuse, Utah, Förenta staterna, 84075
- Rekrytering
- AMR Clinical
-
-
Virginia
-
Richmond, Virginia, Förenta staterna, 23226
- Rekrytering
- Clinical Research Partners, LLC
-
Richmond, Virginia, Förenta staterna, 23233
- Rekrytering
- Tekton Research, LLC.
-
-
Wisconsin
-
Marshfield, Wisconsin, Förenta staterna, 54449
- Rekrytering
- Marshfield Medical Center - Marshfield
-
-
-
-
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Fukui, Japan, 910-0833
- Rekrytering
- Fukui Aiiku Hospital
-
Fukuoka, Japan, 813-0036
- Rekrytering
- Fukazawa Pediatric Clinic
-
Osaka, Japan, 544-0033
- Rekrytering
- Kubota Children's Clinic
-
-
Aichi-ken
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Toyota-shi, Aichi-ken, Japan, 471-8513
- Rekrytering
- Toyota Memorial Hospital
-
-
Fukuoka
-
Fukuoka, Fukuoka, Japan, 814-0121
- Rekrytering
- Shindo children's clinic
-
Kasuga, Fukuoka, Japan, 816-0801
- Rekrytering
- Yokoyama Children'S Clinic
-
-
Hokkaido
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Sapporo, Hokkaido, Japan, 062-0907
- Rekrytering
- Ohigesenseino Kodomo Clinic
-
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Kagoshima-ken
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Hioki, Kagoshima-ken, Japan, 899-2503
- Rekrytering
- Nintenkaikagoshima Children's Hospital
-
-
Tokyo
-
Shinjuku-ku, Tokyo, Japan, 160-0017
- Rekrytering
- Futaba Clinic
-
-
Yamanashi
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Kofu, Yamanashi, Japan, 400-0853
- Rekrytering
- Kose Children Clinic
-
-
-
-
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Bayamón, Puerto Rico, 00960
- Rekrytering
- Clinical Research Investigator Group
-
Caguas, Puerto Rico, 00726
- Rekrytering
- San Juan Bautista School of Medicine - Clinical Research Unit
-
Caguas, Puerto Rico, 00725
- Rekrytering
- Caguas Clinical Research
-
Guayama, Puerto Rico, 00784
- Rekrytering
- Clinical Research Puerto Rico
-
Ponce, Puerto Rico, 00716
- Rekrytering
- Ponce Medical School Foundation Inc./ CAIMED Center
-
Ponce, Puerto Rico, 00728
- Rekrytering
- BRCR Global Puerto Rico
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San Juan, Puerto Rico, 00907
- Rekrytering
- BRCR Global Puerto Rico
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Trujillo Alto, Puerto Rico, 00976-3910
- Rekrytering
- San Miguel Medical
-
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
Tar emot friska volontärer
Ja
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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 pneumokockkonjugatvaccin (20vPnC)
Andra namn:
|
|
Experimentell: 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 pneumokockkonjugatvaccin (20vPnC)
Andra namn:
|
|
Experimentell: Group 3 PG4 (intramuscular)
Multivalent Pneumococcal Vaccine
|
Multivalent Pneumococcal Vaccine
|
|
Experimentell: 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 pneumokockkonjugatvaccin (20vPnC)
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Andel deltagare som rapporterar lokala reaktioner inom 7 dagar efter varje dos
Tidsram: Dag 7
|
Föranledde lokala reaktioner efter varje dos
|
Dag 7
|
|
Andel deltagare som rapporterar allvarliga biverkningar (SAE)
Tidsram: Dos 1 till 6 månader efter dos 4
|
SAE som inträffar från dos 1 till 6 månader efter dos 4
|
Dos 1 till 6 månader efter dos 4
|
|
Percentage of participants reporting systemic events within 7 days after each dose
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 1 month after Dose 4
|
Pneumococcal IgG GMCs 1 month after Dose 4
|
1 month after Dose 4
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pneumococcal IgG GMCs 1 month after Dose 3
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Prior to Dose 4
|
Pneumococcal OPA titers prior to Dose 4
|
Prior to Dose 4
|
|
Pneumococcal OPA titers 1 month after Dose 4
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Prior to Dose 4
|
Pneumococcal IgG concentrations prior to Dose 4
|
Prior to Dose 4
|
|
Pneumococcal IgG concentrations 1 month after Dose 4
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 1 month after Dose 3
|
Geometric mean of IgA antibody levels to rotavirus 1 month after Dose 3
|
1 month after Dose 3
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Pfizer CT.gov Call Center, Pfizer
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
29 maj 2026
Primärt slutförande (Beräknad)
5 juni 2029
Avslutad studie (Beräknad)
5 juni 2029
Studieregistreringsdatum
Först inskickad
27 maj 2026
Först inskickad som uppfyllde QC-kriterierna
4 juni 2026
Första postat (Faktisk)
5 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
8 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
4 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- C4931008
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
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.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .