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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-523447-35-00 | Registry Identifier | CTIS (EU) |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PG4 (intramuscular) | Experimental | Multivalent Pneumococcal Vaccine |
|
| 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular) | Active Comparator | 20-valent pneumococcal conjugate vaccine (20vPnC) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PG4 | Biological | Multivalent Pneumococcal Vaccine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants reporting local reactions within 7 days after each dose | Prompted local reactions after each dose | Day 7 |
| Percentage of participants reporting systemic events within 7 days after each dose | Prompted systemic events after each dose | Day 7 |
| Percentage of participants reporting adverse events (AEs) from Dose 1 to 1 month after Dose 3 | AEs occurring from Dose 1 to 1 month after Dose 3 | Dose 1 to 1 month after Dose 3 |
| Percentage of participants reporting AEs from Dose 4 to 1 month after Dose 4 | AEs occurring from Dose 4 to 1 month after Dose 4 | Dose 4 to 1 month after Dose 4 |
| Percentage of participants reporting serious adverse events (SAEs) | SAEs occurring from Dose 1 to 6 months after Dose 4 | Dose 1 to 6 months after Dose 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Starz Pediatrics | Recruiting | Estero | Florida | 33928 | United States | |
| Innovate Research Centers, LLC |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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Parallel assignment
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| 20-valent pneumococcal conjugate vaccine (20vPnC) |
| Biological |
20-valent pneumococcal conjugate vaccine (20vPnC) |
|
|
| Recruiting |
| Fort Lauderdale |
| Florida |
| 33304 |
| United States |
| MacKoul Pediatrics Fort Myers | Recruiting | Fort Myers | Florida | 33908 | United States |
| Rophe Adult and Pediatric Medicine/SKYCRNG | Recruiting | Union City | Georgia | 30291 | United States |
| Rosemark Women Care Specialists | Recruiting | Idaho Falls | Idaho | 83404 | United States |
| Eagle Clinical Research | Not yet recruiting | Chicago | Illinois | 60621 | United States |
| Kentucky Pediatric/ Adult Research | Recruiting | Bardstown | Kentucky | 40004 | United States |
| LSU Health Shreveport Clinical Trials Office | Recruiting | Shreveport | Louisiana | 71101 | United States |
| Ochsner/LSU Health Shreveport - Progressive Pediatrics | Recruiting | Shreveport | Louisiana | 71101 | United States |
| Ochsner LSU Health Shreveport Ambulatory Care Center | Recruiting | Shreveport | Louisiana | 71103 | United States |
| Ochsner/LSU Health Shreveport Academic Medical Center | Recruiting | Shreveport | Louisiana | 71103 | United States |
| Pediatric Associates of Fall River | Not yet recruiting | Fall River | Massachusetts | 02721 | United States |
| Boston Children's Health Physicians | Recruiting | Hawthorne | New York | 10532 | United States |
| Maria Fareri Children's Hospital | Recruiting | Valhalla | New York | 10595 | United States |
| Senders Pediatrics | Recruiting | South Euclid | Ohio | 44121 | United States |
| Legacy Clinical Trials | Recruiting | Oklahoma City | Oklahoma | 73103 | United States |
| Cyn3rgy Research Corporation | Recruiting | Gresham | Oregon | 97030 | United States |
| Tribe Clinical Research LLC. at Parkside Pediatrics Five Forks | Recruiting | Simpsonville | South Carolina | 29680 | United States |
| Pediatric Research of Charlottesville, LLC. | Recruiting | Gordonsville | Virginia | 22942 | United States |
| Milestone Research Inc. | Not yet recruiting | London | Ontario | N5W 6A2 | Canada |
| Bluewater Clinical Research Group Inc. | Not yet recruiting | Sarnia | Ontario | N7T 4X3 | Canada |
| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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