Who may participate

Each clinical study has its own guidelines for who may participate, called eligibility criteria. These factors can include your age, sex, overall health, type and stage of disease, and personal treatment history. However, only the research study staff can determine if you qualify to enroll in the study.

Condition
Pneumococcal Disease
Sex
Male or Female
Age
42 - 98 days
Healthy participants
Yes

Eligibility criteria

Study overview

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.

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    Miles
    0500

    Nearest Locations found

    4 sites found

    Pediatric Research of Charlottesville, LLC

    Gordonsville, Virginia, United States, 22942
    Site Info

    Rophe Adult and Pediatric Medicine/SKYCRNG

    Union City, Georgia, United States, 30291
    Site Info

    Starz Pediatrics

    Estero, Florida, United States, 33928
    Site Info

    Tribe Clinical Research LLC. at Parkside Pediatrics Five Forks

    Simpsonville, South Carolina, United States, 29680
    Site Info
    • Recruitment Status
    • Site details
    • Study Contact
    • Clinical Trials ID

    Study Locations

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