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RECRUITING Phase 3 ClinicalTrials.gov

A Study to Learn About How a New Pneumococcal Vaccine Works in Infants.

Sponsor: Pfizer • ClinicalTrials.gov ID: NCT07629440

Registry updated: 2026-10-20
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Description

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.

Interventions

  • PG4 (Biological)
    Multivalent Pneumococcal Vaccine
  • 20-valent pneumococcal conjugate vaccine (20vPnC) (Biological)
    20-valent pneumococcal conjugate vaccine (20vPnC)

Eligibility criteria

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.

Conditions

Pneumococcal Disease

Locations

  • KUR Research, LLC — Bessemer, Alabama, United States
  • Alabama Clinical Therapeutics, LLC Birmingham Pediatric Associates — Birmingham, Alabama, United States
  • University of Alabama at Birmingham - School of Medicine — Birmingham, 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
  • Advanced Research Center, Inc. — Anaheim, California, United States
  • San Gabriel Woman's Health — Arcadia, California, United States
  • Coast Clinical Research, LLC — Bellflower, 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
  • Barroso Medical Services LLC — Hialeah, Florida, United States
  • C & R Research Services USA — Homestead, Florida, United States
  • Florida Pharmaceutical Research and Associates, Inc. — Miami, Florida, United States
  • International Research II, LLC. — 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
  • South Tampa Center for Advanced Healthcare- USF Health — Tampa, Florida, United States
  • USF Health — Tampa, Florida, United States
  • USF Health Department of Pediatrics The Chalsty Clinics at the Curran Children's Health Center (CMS) — Tampa, Florida, United States
  • Children's Health Center — Tampa, Florida, United States
  • ObjectiveHealth Clinical Research LLC - Chamblee — Chamblee, Georgia, 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
  • University of Maryland, Baltimore, Center for Vaccine Development and Global Health — Baltimore, Maryland, United States
  • Kur Research, LLC — Columbia, Maryland, United States
  • The Pediatric Center — 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
  • University of Missouri Pediatrics Clinic-South Providence — Columbia, Missouri, United States
  • University of Missouri — Columbia, Missouri, 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
  • UPMC Children's Community Pediatrics- Bellevue — Bellevue, Pennsylvania, United States
  • UPMC Children's Community Pediatrics Bass Wolfson-Cranberry — Cranberry Township, Pennsylvania, United States
  • Allegheny Health and Wellness Pavilion — Erie, Pennsylvania, United States
  • UPMC Children's Community Pediatrics South Hills-Jefferson Hills — Jefferson Hills, Pennsylvania, United States
  • UPMC Children's Community Pediatrics - Norwin — North Huntingdon, Pennsylvania, United States
  • UPMC Children's Hospital of Pittsburgh Primary Care Center-Oakland — Pittsburgh, Pennsylvania, United States
  • UPMC Children's Community Pediatrics Bass Wolfson-Squirrel Hill — Pittsburgh, Pennsylvania, United States
  • UPMC Children's Community Pediatrics-Brentwood — Pittsburgh, Pennsylvania, United States
  • UPMC Children's Community Pediatrics-Castle Shannon — Pittsburgh, Pennsylvania, United States
  • Tribe Clinical Research LLC. at Parkside Pediatrics Harrison Bridge Road — Simpsonville, South Carolina, United States
  • Carolina Family Care — Summerville, South Carolina, United States
  • MUSC Children's Health — Summerville, South Carolina, United States
  • Le Bonheur Children's Hospital - Outpatient Building — Memphis, Tennessee, United States
  • Pediatric Clinical Trials of Tennessee, LLC — Tullahoma, Tennessee, United States
  • Proactive RGV — Brownsville, Texas, United States
  • South Texas Clinical Research — Corpus Christi, Texas, United States
  • Proactive Clinical Research LLC — Edinburg, Texas, United States
  • Proactive El Paso,LLC — El Paso, Texas, United States
  • SMS Clinical Research LLC. — Forney, Texas, United States
  • University of Texas Medical Branch, Sealy Institute for Vaccine Sciences Clinical Trials Program — Galveston, Texas, United States
  • HG Pediatrics/Chemidox TX LLC — Houston, Texas, United States
  • Neutra Life Sciences — Houston, Texas, United States
  • Mercury Clinical Research (Administrative Office) — Houston, Texas, United States
  • Mercury Clinical Research - Administrative Office (Archival Purposes) — Houston, Texas, United States
  • Kool Kids Pediatrics — Houston, Texas, United States
  • Aavon Clinical Trials, LLC. — Houston, Texas, United States
  • RTX Clinical Research — Houston, Texas, United States
  • Mercury Clinical Research - Sunrise Pediatrics — Houston, Texas, United States
  • Mercury Clinical Research - MD Kids Pediatrics — 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
  • 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
  • Crossroads Clinical Research — Victoria, 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
  • Marshfield Medical Center - Marshfield — Marshfield, Wisconsin, United States
  • TOYOTA Memorial Hospital — Toyota-shi, Aichi-ken, Japan
  • Fukui Aiiku Hospital — Fukui-shi, Fukui, Japan
  • Fukazawa Pediatric Clinic — Fukuoka, Fukuoka, 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
  • Kubota Children's Clinic — Osaka, Osaka, Japan
  • Hosaka Children's Clinic — Bunkyo, Tokyo, Japan
  • Futaba Clinic — Shinjuku-ku, Tokyo, Japan
  • Kose Children Clinic — Kofu, Yamanashi, Japan
  • Clinical Research Investigator Group — Bayamón, Puerto RICO, Puerto Rico
  • Caguas Clinical Research — Caguas, Puerto RICO, Puerto Rico
  • San Juan Bautista School of Medicine - Clinical Research Unit — Caguas, Puerto RICO, Puerto Rico
  • Clinical Research Puerto Rico — Guayama, Puerto RICO, Puerto Rico
  • Ponce Medical School Foundation Inc./ CAIMED Center — Ponce, Puerto RICO, Puerto Rico
  • BRCR Global Puerto Rico — Ponce, Puerto RICO, Puerto Rico
  • BRCR Global Puerto Rico — San Juan, Puerto RICO, Puerto Rico
  • San Miguel Medical — Trujillo Alto, Puerto RICO, Puerto Rico
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record