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A Study to Learn About How a New Pneumococcal Vaccine Works in 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. 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.
Official title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS
Key Details
Gender
All
Age Range
42 Days - 211 Days
Study Type
INTERVENTIONAL
Enrollment
3230
Start Date
2026-05-29
Completion Date
2029-06-05
Last Updated
2026-07-09
Healthy Volunteers
Yes
Conditions
Interventions
PG4
Multivalent Pneumococcal Vaccine
20-valent pneumococcal conjugate vaccine (20vPnC)
20-valent pneumococcal conjugate vaccine (20vPnC)
Locations (97)
Alabama Clinical Therapeutics, LLC Birmingham Pediatric Associates
Birmingham, Alabama, United States
University of Alabama at Birmingham - School of Medicine
Birmingham, Alabama, United States
KUR Research, LLC
Centreville, Alabama, United States
Northwest Arkansas Pediatric Clinic
Fayetteville, Arkansas, United States
The Children's Clinic of Jonesboro, P.A.
Jonesboro, Arkansas, United States
Helios Clinical Research
Sherwood, Arkansas, United States
San Gabriel Woman's Health
Arcadia, California, United States
Family Medical Clinic
El Monte, California, United States
Clinical Research of Central California
Fresno, California, United States
SeraCollection Research Services, LLC
Montebello, California, United States
Bailony Pediatrics
National City, California, United States
Stanford University Medical Center
Palo Alto, California, United States
Childrens Hospital of Colorado
Aurora, Colorado, United States
Direct Helpers Research Center
Hialeah, Florida, United States
C & R Research Services USA
Homestead, Florida, United States
Florida Pharmaceutical Research and Associates, Inc.
Miami, Florida, United States
Bioresearch Partner
Miami, Florida, United States
Gold Coast Health Research Center, LLC
Miami, Florida, United States
Dade Research Center
Miami, Florida, United States
Vasconcello-Cohen MD Research, LLC.
Miami, Florida, United States
Riveldi and Associates
Miami Lakes, Florida, United States
Eminent Clinical Research and Associates
North Lauderdale, Florida, United States
Cordova Research Institute LLC
Sweetwater, Florida, United States
Altruistic Clinical Research Global
Norcross, Georgia, United States
Medical Research Partners
Ammon, Idaho, United States
Bingham Memorial Hospital
Blackfoot, Idaho, United States
ASR, LLC
Boise, Idaho, United States
Leavitt Clinical Research
Idaho Falls, Idaho, United States
MidValley Research, Inc
Moline, Illinois, United States
The Iowa Clinic.
Ankeny, Iowa, United States
Eximia Research - IA, LLC (dba Integrated Clinical Trial Services, LLC)
West Des Moines, Iowa, United States
Integrity Clinical Network, LLC
Derby, Kansas, United States
ACC Pediatric Research
Haughton, Louisiana, United States
Kur Research, LLC
Columbia, Maryland, United States
Michigan Institute of Research
Allen Park, Michigan, United States
Michigan Center of Medical Research
Bingham Farms, Michigan, United States
Vida Clinical Studies, LLC
Dearborn Heights, Michigan, United States
Velocity Clinical Research, Grand Island
Grand Island, Nebraska, United States
Midwest Children's Health Research Institute
Lincoln, Nebraska, United States
Midwest Children's Health Research Institute
Lincoln, Nebraska, United States
Midwest Children's Health Research Institute
Lincoln, Nebraska, United States
Midwest Children's Health Research Institute
Lincoln, Nebraska, United States
Child Health Care Associates
East Syracuse, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Atrium Health Cannon Research Cente
Charlotte, North Carolina, United States
Atrium Health - STRIVE Research clinic
Charlotte, North Carolina, United States
Atrium Health Levine Children's Myers Park Pediatrics
Charlotte, North Carolina, United States
Duke Vaccine and Trials Unit
Durham, North Carolina, United States
Durham Pediatrics at North Duke Street
Durham, North Carolina, United States
Atrium Health Levine Children's Charlotte Pediatrics
Matthews, North Carolina, United States
Atrium Health STRIVE Research Clinic - Matthews
Matthews, North Carolina, United States
Wilmington Health
Wilmington, North Carolina, United States
Pediatric Associates of Mt. Carmel
Cincinnati, Ohio, United States
PriMED Clinical Research
Dayton, Ohio, United States
Senders Pediatrics
South Euclid, Ohio, United States
Allegheny Health and Wellness Pavilion
Erie, Pennsylvania, United States
Tribe Clinical Research LLC. at Parkside Pediatrics Harrison Bridge Road
Simpsonville, South Carolina, United States
Pediatric Clinical Trials of Tennessee, LLC
Tullahoma, Tennessee, United States
Proactive RGV
Brownsville, Texas, United States
Proactive Clinical Research LLC
Edinburg, Texas, United States
Proactive El Paso,LLC
El Paso, Texas, United States
University of Texas Medical Branch, Sealy Institute for Vaccine Sciences Clinical Trials Program
Galveston, Texas, United States
Neutra Life Sciences
Houston, Texas, United States
Mercury Clinical Research (Administrative Office)
Houston, Texas, United States
Kool Kids Pediatrics
Houston, Texas, United States
Aavon Clinical Trials, LLC.
Houston, Texas, United States
Mercury Clinical Research - Sunrise Pediatrics
Houston, Texas, United States
Mercury Clinical Research - Pediatric Associates
Houston, Texas, United States
Houston Clinical Research Associates
Houston, Texas, United States
Prime Clinical Research - Lewisville
Lewisville, Texas, United States
Prime Clinical Research - Mansfield
Mansfield, Texas, United States
Dr. Ruben Aleman & Associates
McAllen, Texas, United States
SMS Clinical Research LLC
Mesquite, Texas, United States
Pediatric Center- Neutra Life Sciences
Richmond, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
AMR Clinical
Provo, Utah, United States
AMR Clinical
Syracuse, Utah, United States
Clinical Research Partners, LLC
Richmond, Virginia, United States
Tekton Research, LLC.
Richmond, Virginia, United States
TOYOTA Memorial Hospital
Toyota-shi, Aichi-ken, Japan
Shindo children's clinic
Fukuoka, Fukuoka, Japan
Yokoyama Children'S Clinic
Kasuga, Fukuoka, Japan
Ohigesenseino Kodomo Clinic
Sapporo, Hokkaido, Japan
Nintenkaikagoshima Children's Hospital
Hioki, Kagoshima-ken, Japan
Futaba Clinic
Shinjuku-ku, Tokyo, Japan
Kose Children Clinic
Kofu, Yamanashi, Japan
Fukui Aiiku Hospital
Fukui, Japan
Fukazawa Pediatric Clinic
Fukuoka, Japan
Kubota Children's Clinic
Osaka, Japan
Clinical Research Investigator Group
Bayamón, Puerto Rico
Caguas Clinical Research
Caguas, Puerto Rico
San Juan Bautista School of Medicine - Clinical Research Unit
Caguas, Puerto Rico
Clinical Research Puerto Rico
Guayama, Puerto Rico
Ponce Medical School Foundation Inc./ CAIMED Center
Ponce, Puerto Rico
BRCR Global Puerto Rico
Ponce, Puerto Rico
BRCR Global Puerto Rico
San Juan, Puerto Rico
San Miguel Medical
Trujillo Alto, Puerto Rico