A Study to Learn About How a New Pneumococcal Vaccine Works in Infants.
4 september 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Werving
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
3230
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Pfizer CT.gov Call Center
- Telefoonnummer: 1-800-718-1021
- E-mail: ClinicalTrials.gov_Inquiries@pfizer.com
Studie Locaties
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Fukui, Japan, 910-0833
- Werving
- Fukui Aiiku Hospital
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Fukuoka, Japan, 813-0036
- Werving
- Fukazawa Pediatric Clinic
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Osaka, Japan, 544-0033
- Werving
- Kubota Children's Clinic
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Aichi-ken
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Toyota-shi, Aichi-ken, Japan, 471-8513
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- Toyota Memorial Hospital
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Fukuoka
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Fukuoka, Fukuoka, Japan, 814-0121
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- Shindo children's clinic
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Kasuga, Fukuoka, Japan, 816-0801
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- Yokoyama Children'S Clinic
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Hokkaido
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Sapporo, Hokkaido, Japan, 062-0907
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- Ohigesenseino Kodomo Clinic
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Kagoshima-ken
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Hioki, Kagoshima-ken, Japan, 899-2503
- Werving
- Nintenkaikagoshima Children's Hospital
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Tokyo
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Shinjuku-ku, Tokyo, Japan, 160-0017
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- Futaba Clinic
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Yamanashi
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Kofu, Yamanashi, Japan, 400-0853
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- Kose Children Clinic
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Bayamón, Puerto Rico, 00960
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- Clinical Research Investigator Group
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Caguas, Puerto Rico, 00726
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- San Juan Bautista School of Medicine - Clinical Research Unit
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Caguas, Puerto Rico, 00725
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- Caguas Clinical Research
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Guayama, Puerto Rico, 00784
- Werving
- Clinical Research Puerto Rico
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Ponce, Puerto Rico, 00716
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- Ponce Medical School Foundation Inc./ CAIMED Center
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Ponce, Puerto Rico, 00728
- Werving
- BRCR Global Puerto Rico
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San Juan, Puerto Rico, 00907
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- BRCR Global Puerto Rico
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Trujillo Alto, Puerto Rico, 00976-3910
- Werving
- San Miguel Medical
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Alabama
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Bessemer, Alabama, Verenigde Staten, 35022
- Nog niet aan het werven
- Kur Research, LLC
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Birmingham, Alabama, Verenigde Staten, 35233
- Werving
- University of Alabama at Birmingham - School of Medicine
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Birmingham, Alabama, Verenigde Staten, 35205
- Werving
- Alabama Clinical Therapeutics, LLC Birmingham Pediatric Associates
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Centreville, Alabama, Verenigde Staten, 35042
- Nog niet aan het werven
- Kur Research, LLC
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Arkansas
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Fayetteville, Arkansas, Verenigde Staten, 72703
- Werving
- Northwest Arkansas Pediatric Clinic
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Jonesboro, Arkansas, Verenigde Staten, 72401
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- The Children's Clinic of Jonesboro, P.A.
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Sherwood, Arkansas, Verenigde Staten, 72120
- Werving
- Helios Clinical Research
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California
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Anaheim, California, Verenigde Staten, 92805
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- Advanced Research Center, Inc.
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Arcadia, California, Verenigde Staten, 91007
- Werving
- San Gabriel Woman's Health
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Bellflower, California, Verenigde Staten, 90706
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- Coast Clinical Research, LLC
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El Monte, California, Verenigde Staten, 91731
- Werving
- Family Medical Clinic
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Fresno, California, Verenigde Staten, 93704
- Werving
- Clinical Research of Central California
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Montebello, California, Verenigde Staten, 90640
- Werving
- SeraCollection Research Services, LLC
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National City, California, Verenigde Staten, 91950
- Werving
- Bailony Pediatrics
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Palo Alto, California, Verenigde Staten, 94304
- Nog niet aan het werven
- Stanford University Medical Center
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Colorado
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Aurora, Colorado, Verenigde Staten, 80045
- Werving
- Childrens Hospital of Colorado
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Florida
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Hialeah, Florida, Verenigde Staten, 33012
- Werving
- Direct Helpers Research Center
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Homestead, Florida, Verenigde Staten, 33030
- Werving
- C & R Research Services USA
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Miami, Florida, Verenigde Staten, 33155
- Werving
- Gold Coast Health Research Center, LLC
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Miami, Florida, Verenigde Staten, 33155
- Werving
- Bioresearch Partner
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Miami, Florida, Verenigde Staten, 33143
- Werving
- Florida Pharmaceutical Research and Associates, Inc.
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Miami, Florida, Verenigde Staten, 33173
- Werving
- Dade Research Center
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Miami, Florida, Verenigde Staten, 33183
- Werving
- Vasconcello-Cohen MD Research, LLC.
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Miami Lakes, Florida, Verenigde Staten, 33014
- Werving
- Riveldi and Associates
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North Lauderdale, Florida, Verenigde Staten, 33068
- Werving
- Eminent Clinical Research and Associates
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Sweetwater, Florida, Verenigde Staten, 33182
- Werving
- Cordova Research Institute LLC
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Tampa, Florida, Verenigde Staten, 33617
- Werving
- Children's Health Center
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Georgia
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Chamblee, Georgia, Verenigde Staten, 30341
- Nog niet aan het werven
- ObjectiveHealth Clinical Research LLC - Chamblee
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Norcross, Georgia, Verenigde Staten, 30093
- Werving
- Altruistic Clinical Research Global
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Idaho
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Ammon, Idaho, Verenigde Staten, 83406
- Werving
- Medical Research Partners
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Blackfoot, Idaho, Verenigde Staten, 83221
- Werving
- Bingham Memorial Hospital
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Boise, Idaho, Verenigde Staten, 83702
- Werving
- ASR, LLC
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Idaho Falls, Idaho, Verenigde Staten, 83404
- Werving
- Leavitt Clinical Research
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Illinois
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Moline, Illinois, Verenigde Staten, 61265
- Werving
- MidValley Research, Inc
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Iowa
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Ankeny, Iowa, Verenigde Staten, 50023
- Werving
- The Iowa Clinic.
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West Des Moines, Iowa, Verenigde Staten, 50265
- Werving
- Eximia Research - IA, LLC (dba Integrated Clinical Trial Services, LLC)
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Kansas
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Derby, Kansas, Verenigde Staten, 67037
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- Integrity Clinical Network, LLC
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Louisiana
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Haughton, Louisiana, Verenigde Staten, 71037
- Werving
- ACC Pediatric Research
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Maryland
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Baltimore, Maryland, Verenigde Staten, 21201
- Nog niet aan het werven
- University of Maryland, Baltimore, Center for Vaccine Development and Global Health
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Columbia, Maryland, Verenigde Staten, 21045
- Nog niet aan het werven
- The Pediatric Center
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Columbia, Maryland, Verenigde Staten, 21045
- Werving
- Kur Research, LLC
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Michigan
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Allen Park, Michigan, Verenigde Staten, 48101
- Werving
- Michigan Institute of Research
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Bingham Farms, Michigan, Verenigde Staten, 48025
- Werving
- Michigan Center of Medical Research
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Dearborn Heights, Michigan, Verenigde Staten, 48127
- Werving
- Vida Clinical Studies, LLC
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Missouri
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Columbia, Missouri, Verenigde Staten, 65212
- Werving
- University of Missouri
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Columbia, Missouri, Verenigde Staten, 65201
- Werving
- University of Missouri Pediatrics Clinic-South Providence
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Nebraska
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Grand Island, Nebraska, Verenigde Staten, 68803
- Werving
- Velocity Clinical Research, Grand Island
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Lincoln, Nebraska, Verenigde Staten, 68504
- Werving
- Midwest Children's Health Research Institute
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Lincoln, Nebraska, Verenigde Staten, 68505
- Werving
- Midwest Children's Health Research Institute
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Lincoln, Nebraska, Verenigde Staten, 68516
- Werving
- Midwest Children's Health Research Institute
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Lincoln, Nebraska, Verenigde Staten, 68522
- Werving
- Midwest Children's Health Research Institute
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New York
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East Syracuse, New York, Verenigde Staten, 13057
- Werving
- Child Health Care Associates
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Rochester, New York, Verenigde Staten, 14642
- Werving
- University of Rochester Medical Center
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North Carolina
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Charlotte, North Carolina, Verenigde Staten, 28203
- Werving
- Atrium Health Cannon Research Cente
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Charlotte, North Carolina, Verenigde Staten, 28207
- Werving
- Atrium Health - STRIVE Research clinic
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Charlotte, North Carolina, Verenigde Staten, 28207
- Werving
- Atrium Health Levine Children's Myers Park Pediatrics
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Durham, North Carolina, Verenigde Staten, 27703
- Werving
- Duke Vaccine and Trials Unit
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Durham, North Carolina, Verenigde Staten, 27704
- Werving
- Durham Pediatrics at North Duke Street
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Matthews, North Carolina, Verenigde Staten, 28105
- Werving
- Atrium Health Levine Children's Charlotte Pediatrics
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Matthews, North Carolina, Verenigde Staten, 28105
- Werving
- Atrium Health STRIVE Research Clinic - Matthews
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Wilmington, North Carolina, Verenigde Staten, 28405
- Werving
- Wilmington Health
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Ohio
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Cincinnati, Ohio, Verenigde Staten, 45245
- Werving
- Pediatric Associates of Mt. Carmel
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Dayton, Ohio, Verenigde Staten, 45429
- Werving
- PriMed Clinical Research
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South Euclid, Ohio, Verenigde Staten, 44121
- Werving
- Senders Pediatrics
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Pennsylvania
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Bellevue, Pennsylvania, Verenigde Staten, 15202
- Werving
- UPMC Children's Community Pediatrics- Bellevue
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Cranberry Township, Pennsylvania, Verenigde Staten, 16066
- Werving
- UPMC Children's Community Pediatrics Bass Wolfson-Cranberry
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Erie, Pennsylvania, Verenigde Staten, 16506
- Werving
- Allegheny Health and Wellness Pavilion
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Jefferson Hills, Pennsylvania, Verenigde Staten, 15025
- Werving
- UPMC Children's Community Pediatrics South Hills-Jefferson Hills
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N. Huntingdon, Pennsylvania, Verenigde Staten, 15642
- Werving
- UPMC Children's Community Pediatrics - Norwin
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Pittsburgh, Pennsylvania, Verenigde Staten, 15217
- Werving
- UPMC Children's Community Pediatrics Bass Wolfson-Squirrel Hill
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Pittsburgh, Pennsylvania, Verenigde Staten, 15234
- Werving
- UPMC Children's Community Pediatrics-Castle Shannon
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Pittsburgh, Pennsylvania, Verenigde Staten, 15213
- Werving
- UPMC Children's Hospital of Pittsburgh Primary Care Center-Oakland
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Pittsburgh, Pennsylvania, Verenigde Staten, 15227
- Werving
- UPMC Children's Community Pediatrics-Brentwood
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South Carolina
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Simpsonville, South Carolina, Verenigde Staten, 29680
- Werving
- Tribe Clinical Research LLC. at Parkside Pediatrics Harrison Bridge Road
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Summerville, South Carolina, Verenigde Staten, 29486
- Werving
- Carolina Family Care
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Summerville, South Carolina, Verenigde Staten, 29486
- Werving
- MUSC Children's Health
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Tennessee
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Memphis, Tennessee, Verenigde Staten, 38105
- Nog niet aan het werven
- Le Bonheur Children's Hospital - Outpatient Building
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Tullahoma, Tennessee, Verenigde Staten, 37388
- Werving
- Pediatric Clinical Trials of Tennessee, LLC
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Texas
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Brownsville, Texas, Verenigde Staten, 78520
- Werving
- Proactive RGV
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Corpus Christi, Texas, Verenigde Staten, 78404
- Nog niet aan het werven
- South Texas Clinical Research
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Edinburg, Texas, Verenigde Staten, 78539
- Werving
- Proactive Clinical Research LLC
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El Paso, Texas, Verenigde Staten, 79902
- Werving
- Proactive El Paso,LLC
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Forney, Texas, Verenigde Staten, 75126
- Werving
- SMS Clinical Research LLC.
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Galveston, Texas, Verenigde Staten, 77555
- Werving
- University of Texas Medical Branch, Sealy Institute for Vaccine Sciences Clinical Trials Program
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Houston, Texas, Verenigde Staten, 77065
- Werving
- Kool Kids Pediatrics
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Houston, Texas, Verenigde Staten, 77090
- Werving
- Houston Clinical Research Associates
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Houston, Texas, Verenigde Staten, 77054
- Werving
- Mercury Clinical Research (Administrative Office)
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Houston, Texas, Verenigde Staten, 77077
- Werving
- Mercury Clinical Research - Sunrise Pediatrics
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Houston, Texas, Verenigde Staten, 77042
- Werving
- Neutra Life Sciences
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Houston, Texas, Verenigde Staten, 77087
- Werving
- Mercury Clinical Research - MD Kids Pediatrics
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Houston, Texas, Verenigde Staten, 77057
- Nog niet aan het werven
- UDL Clinical Research, LLC.
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Houston, Texas, Verenigde Staten, 77074
- Werving
- Aavon Clinical Trials, LLC.
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Houston, Texas, Verenigde Staten, 77074
- Werving
- RTX Clinical Research
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Lewisville, Texas, Verenigde Staten, 75067
- Werving
- Prime Clinical Research - Lewisville
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Mansfield, Texas, Verenigde Staten, 76063
- Werving
- Prime Clinical Research - Mansfield
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McAllen, Texas, Verenigde Staten, 78504
- Werving
- Dr. Ruben Aleman & Associates
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Mesquite, Texas, Verenigde Staten, 75149
- Werving
- SMS Clinical Research LLC
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Mesquite, Texas, Verenigde Staten, 75150
- Werving
- SMS Clinical Research LLC
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Richmond, Texas, Verenigde Staten, 77469
- Werving
- Pediatric Center- Neutra Life Sciences
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San Antonio, Texas, Verenigde Staten, 78215
- Werving
- Sun Research Institute
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Victoria, Texas, Verenigde Staten, 77901
- Nog niet aan het werven
- Crossroads Clinical Research
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Utah
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Provo, Utah, Verenigde Staten, 84604
- Werving
- AMR Clinical
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Syracuse, Utah, Verenigde Staten, 84075
- Werving
- AMR Clinical
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Virginia
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Richmond, Virginia, Verenigde Staten, 23226
- Werving
- Clinical Research Partners, LLC
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Richmond, Virginia, Verenigde Staten, 23233
- Werving
- Tekton Research, LLC.
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Wisconsin
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Marshfield, Wisconsin, Verenigde Staten, 54449
- Werving
- Marshfield Medical Center - Marshfield
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
Accepteert gezonde vrijwilligers
Ja
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Group 1 PG4 (intramuscular)
Multivalent Pneumococcal Vaccine
|
Multivalent Pneumococcal Vaccine
|
|
Actieve vergelijker: Group 1 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)
20-valent pneumococcal conjugate vaccine (20vPnC)
|
20-valent pneumokokkenconjugaatvaccin (20vPnC)
Andere namen:
|
|
Experimenteel: Group 2 PG4 (intramuscular)
Multivalent Pneumococcal Vaccine
|
Multivalent Pneumococcal Vaccine
|
|
Actieve vergelijker: Group 2 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)
20-valent pneumococcal conjugate vaccine (20vPnC)
|
20-valent pneumokokkenconjugaatvaccin (20vPnC)
Andere namen:
|
|
Experimenteel: Group 3 PG4 (intramuscular)
Multivalent Pneumococcal Vaccine
|
Multivalent Pneumococcal Vaccine
|
|
Experimenteel: Group 3 PG4 (subcutaneous)
Multivalent Pneumococcal Vaccine
|
Multivalent Pneumococcal Vaccine
|
|
Actieve vergelijker: Group 3 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)
20-valent pneumococcal conjugate vaccine (20vPnC)
|
20-valent pneumokokkenconjugaatvaccin (20vPnC)
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Percentage deelnemers dat lokale reacties meldt binnen 7 dagen na elke dosis
Tijdsspanne: Dag 7
|
Geprovoceerde lokale reacties na elke dosis
|
Dag 7
|
|
Percentage deelnemers dat ernstige bijwerkingen (SAE's) meldt
Tijdsspanne: Dosis 1 tot 6 maanden na dosis 4
|
SAE's die optreden vanaf dosis 1 tot 6 maanden na dosis 4
|
Dosis 1 tot 6 maanden na dosis 4
|
|
Percentage of participants reporting systemic events within 7 days after each dose
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 1 month after Dose 4
|
Pneumococcal IgG GMCs 1 month after Dose 4
|
1 month after Dose 4
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Pneumococcal IgG GMCs 1 month after Dose 3
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Prior to Dose 4
|
Pneumococcal OPA titers prior to Dose 4
|
Prior to Dose 4
|
|
Pneumococcal OPA titers 1 month after Dose 4
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Prior to Dose 4
|
Pneumococcal IgG concentrations prior to Dose 4
|
Prior to Dose 4
|
|
Pneumococcal IgG concentrations 1 month after Dose 4
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
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1 month after Dose 4
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Geometric mean of immunoglobulin A (IgA) antibody levels to rotavirus 1 month after Dose 3
Tijdsspanne: 1 month after Dose 3
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Geometric mean of IgA antibody levels to rotavirus 1 month after Dose 3
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1 month after Dose 3
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: Pfizer CT.gov Call Center, Pfizer
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
29 mei 2026
Primaire voltooiing (Geschat)
5 juni 2029
Studie voltooiing (Geschat)
5 juni 2029
Studieregistratiedata
Eerst ingediend
27 mei 2026
Eerst ingediend dat voldeed aan de QC-criteria
4 juni 2026
Eerst geplaatst (Werkelijk)
5 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
8 september 2026
Laatste update ingediend die voldeed aan QC-criteria
4 september 2026
Laatst geverifieerd
1 september 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- C4931008
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
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.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .