A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants

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. 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.

Interventions

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

Eligibility criteria

Conditions

Locations

• Starz Pediatrics — Estero, Florida, United States
• Innovate Research Centers, LLC — Fort Lauderdale, Florida, United States
• MacKoul Pediatrics Fort Myers — Fort Myers, 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 Shreveport - Progressive Pediatrics — Shreveport, Louisiana, United States
• Ochsner LSU Health Shreveport Ambulatory Care Center — Shreveport, Louisiana, United States
• Ochsner/LSU Health Shreveport Academic Medical Center — Shreveport, Louisiana, United States
• Pediatric Associates of Fall River — Fall River, Massachusetts, 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
• 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
• FVR, Kokkolan rokotetutkimusklinikka — Kokkola, Keski-Pohjanmaa, Finland
• FVR, Oulun rokotetutkimusklinikka — Oulu, North Ostrobothnia, Finland
• FVR, Tampereen rokotetutkimusklinikka — Tampere, Pirkanmaa, 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
• Kinder- und Jugendarztpraxis Dr. med. Michael Horn — Schönau am Königssee, Bavaria, Germany
• SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym — Dziekanów Leśny, Poland