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 children 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. 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 children. Pneumococcal disease includes a variety of infections caused by a specific germ, Streptococcus pneumoniae This study is seeking participants who: * Are children aged 15 months to 18 years. * May or may not have received any doses of pneumococcal conjugate vaccine (PCV) in the past. The study will be conducted in the United States, Puerto Rico, and other countries. Participants will be assigned to 1 of 3 groups based on age: Group 1: 15 months to less than 2 years (about 300 participants) Group 2: 2 years to less than 5 years (about 300 participants) Group 3: 5 years to less than 18 years (about 600 participants) Within each group, participants will be assigned by chance in a 2:1 ratio to receive 1 vaccine injection (shot) with either PG4 (new vaccine) or 20vPnC, given in the arm or thigh. This means that for every 3 participants, about 2 will receive PG4 and about 1 will receive 20vPnC. Each participant will take part in the study for approximately 6 months. During this time, each participant will visit a clinic 2 times (visit 1 for vaccination and visit 2 to follow up) and will be contacted via telephone once (for a 6 month follow up). At the study clinic visits, participants will have their blood drawn and be asked if they have experienced any side effects. A side effect is an unintentional or unexpected reaction to a vaccine. During the 6-month follow-up contact, participants will be asked about any further side effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
1,200
Multivalent Pneumococcal Vaccine
20-valent pneumococcal conjugate vaccine (20vPnC)
Alabama Clinical Therapeutics, LLC Birmingham Pediatric Associates
Birmingham, Alabama, United States
RECRUITINGUAB Child Health Research Unit (CHRU)
Birmingham, Alabama, United States
RECRUITINGLakeview Clinical Research, LLC
Guntersville, Alabama, United States
RECRUITINGApex Research Group
Fair Oaks, California, United States
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Time frame: Within 7 days after Vaccination
Percentage of Participants With Systemic Events Within 7 Days after Vaccination
Time frame: Within 7 days after Vaccination
Percentage of Participants With Adverse Events (AEs)
Time frame: From Vaccination to 1 month after Vaccination
Percentage of Participants With Serious Adverse Events (SAEs)
Time frame: From Vaccination to 6 months after Vaccination
GMCs of serotype-specific IgG concentrations
Time frame: 1 month after vaccination
GMTs of serotype-specific OPA titers
Time frame: 1 month after vaccination
Percentage of participants with predefined serotype-specific IgG concentrations
Time frame: 1 month after vaccination
IgG GMFRs
Time frame: 1 month after vaccination
Percentage of participants with a ≥4-fold rise in serotype-specific OPA titers
Time frame: before to 1 month after vaccination
OPA GMFRs
Time frame: before to 1 month after vaccination
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Orange County Research Institute
Ontario, California, United States
RECRUITINGChildren's Hospital Colorado
Aurora, Colorado, United States
RECRUITINGRiveldi and Associates
Miami Lakes, Florida, United States
RECRUITINGIndago Research & Health Center, Inc
Miami Lakes, Florida, United States
RECRUITINGChildren's Health Center
Tampa, Florida, United States
NOT_YET_RECRUITINGMedical Research Partners
Ammon, Idaho, United States
RECRUITING...and 51 more locations