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A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Sponsor: Pfizer
Summary
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. 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 two groups in this study. All participants will be assigned to one of the two groups. This study is seeking participants who are: \- infants who are about 2 months of age About 2400 infants will be assigned by chance to one of the two groups to receive 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. Infants will take part in this study for about 16 to 19 months (about 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.
Official title: A PHASE 3, RANDOMIZED, DOUBLE-BLINDED TRIAL TO EVALUATE THE SAFETY AND TOLERABILITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS
Key Details
Gender
All
Age Range
42 Days - 98 Days
Study Type
INTERVENTIONAL
Enrollment
2400
Start Date
2026-05-04
Completion Date
2028-12-30
Last Updated
2026-10-26
Healthy Volunteers
Yes
Conditions
Interventions
PG4
Multivalent Pneumococcal Vaccine
20-valent pneumococcal conjugate vaccine (20vPnC)
20-valent pneumococcal conjugate vaccine (20vPnC)
Locations (78)
Starz Pediatrics
Estero, Florida, United States
Innovate Research Centers, LLC
Fort Lauderdale, Florida, United States
MacKoul Pediatrics Fort Myers
Fort Myers, Florida, United States
Speranza Research Center
Hialeah, Florida, United States
Dr. Gala, LLC
Miami, Florida, United States
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, United States
Rosemark Women Care Specialists
Idaho Falls, Idaho, United States
Eagle Clinical Research
Chicago, Illinois, United States
Kentucky Pediatric/ Adult Research
Bardstown, Kentucky, United States
LSU Health Shreveport Clinical Trials Office
Shreveport, Louisiana, United States
Ochsner LSU Health - Progressive Pediatrics
Shreveport, Louisiana, United States
Ochsner LSU Health Shreveport Academic Medical Center
Shreveport, Louisiana, United States
Ochsner LSU Health Shreveport Ambulatory Care Center
Shreveport, Louisiana, United States
Pediatric Associates of Fall River
Fall River, Massachusetts, United States
Lincoln Pediatric Group
Lincoln, Nebraska, United States
Boston Children's Health Physicians
Hawthorne, New York, United States
Maria Fareri Children's Hospital
Valhalla, New York, United States
Senders Pediatrics
South Euclid, Ohio, United States
Legacy Clinical Trials
Oklahoma City, Oklahoma, United States
Cyn3rgy Research Corporation
Gresham, Oregon, United States
Donald Guthrie Foundation
Sayre, Pennsylvania, United States
Guthrie Medical Group
Sayre, Pennsylvania, United States
Tribe Clinical Research LLC. at Parkside Pediatrics Five Forks
Simpsonville, South Carolina, United States
National Research Centers, Plano LLC
Plano, Texas, United States
Pediatric Research of Charlottesville, LLC.
Gordonsville, Virginia, United States
Instituto Médico Río Cuarto
Río Cuarto, Córdoba Province, Argentina
Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L
San Miguel de Tucumán, Tucumán Province, Argentina
Hospital del Niño Jesus
San Miguel de Tucumán, Tucumán Province, Argentina
The Children's Hospital at Westmead
Westmead, New South Wales, Australia
Queensland Children's Hospital
Brisbane, Queensland, Australia
Centre for Children's Health Research
South Brisbane, Queensland, Australia
Monash Health
Clayton, Victoria, Australia
Murdoch Children's Research Institute
Parkville, Victoria, Australia
Perth Children's Hospital
Nedlands, Western Australia, Australia
The Kids Research Institute Australia
Nedlands, Western Australia, Australia
Milestone Research Inc.
London, Ontario, Canada
Bluewater Clinical Research Group Inc.
Sarnia, Ontario, Canada
CHU Sainte-Justine
Montreal, Quebec, Canada
McGill University Health Centre - Vaccine Study Centre
Pierrefonds-Roxboro, Quebec, Canada
FVR, Kokkolan rokotetutkimusklinikka
Kokkola, Keski-Pohjanmaa, Finland
FVR, Oulun rokotetutkimusklinikka
Oulu, North Ostrobothnia, Finland
FVR, Tampereen rokotetutkimusklinikka
Tampere, Pirkanmaa, Finland
FVR, Turun rokotetutkimusklinikka
Turku, Southwest Finland, Finland
FVR, Espoon rokotetutkimusklinikka
Espoo, Uusimaa, Finland
FVR, Etelä-Helsingin rokotetutkimusklinikka
Helsinki, Uusimaa, Finland
MeVac - Meilahti Vaccine Research Center
Helsinki, Uusimaa, Finland
FVR, Järvenpään rokotetutkimusklinikka
Jarvenpaa, Uusimaa, Finland
Gemeinschaftspraxis für Kinder- und Jugendmedizin
Tuttlingen, Baden-Wurttemberg, Germany
Kinder- und Jugendarztpraxis Dr. med. Michael Horn
Schönau am Königssee, Bavaria, Germany
Kinderärztliche Gemeinschaftspraxis Dr. med. Sören Westerholt Dr. med. Jan Matyas
Wolfsburg, Lower Saxony, Germany
Private office pediatrics
Hürth, North Rhine-Westphalia, Germany
Dr. med. Karsten Jünger
Herxheim, Rhineland-Palatinate, Germany
FMZ Radowsky
Leipzig, Saxony, Germany
Praxis J. S. Iffland u. Dr. med. M. Gärtner
Hamburg, Germany
Elitance Duo Kft.
Budapest, Hungary
BEBI-MED Egeszsegugyi Szolgaltato Kft.
Miskolc, Hungary
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano
Milan, Milan, Italy
AOU Policlinico di Bari
Bari, Italy
Policlinico Foggia Hospital
Foggia, Italy
Przylądek Zdrowia
Krakow, Lesser Poland Voivodeship, Poland
ZOZ Medyk
Milówka, Silesian Voivodeship, Poland
IN-VIVO Bydgoszcz
Bydgoszcz, Poland
Pratia S.A.
Bydgoszcz, Poland
SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym
Dziekanów Leśny, Poland
Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o.
Krakow, Poland
Healthy Steps Clinic
Poznan, Poland
MICS Centrum Medyczne Torun
Torun, Poland
Szpital im. Św Jadwigi Śląskiej w Trzebnicy
Trzebnica, Poland
Centrum Medyczne AD-MED Sp. z o.o.
Wroclaw, Poland
NZOZ Salmed
Łęczna, Poland
Instituto Hispalense de Pediatria- IHP1
Seville, Andalusia, Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona [barcelona], Spain
Hospital Universitario de Torrejón
Torrejón de Ardoz, Madrid, Spain
Hm Sanchinarro
Madrid, Madrid, Comunidad de, Spain
HM Montepríncipe
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario HM Puerta del Sur
Madrid, Madrid, Comunidad de, Spain
Hospital Antequera
Antequera, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain