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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-523445-10-00 | 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 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:
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.
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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 With Local Reactions Within 7 Days After Vaccination | Within 7 days after Vaccination | |
| Percentage of Participants With Systemic Events Within 7 Days after Vaccination | Within 7 days after Vaccination | |
| Percentage of Participants With Adverse Events (AEs) | From Vaccination to 1 month after Vaccination | |
| Percentage of Participants With Serious Adverse Events (SAEs) | From Vaccination to 6 months after Vaccination | |
| GMCs of serotype-specific IgG concentrations | 1 month after vaccination | |
| GMTs of serotype-specific OPA titers | 1 month after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with predefined serotype-specific IgG concentrations | 1 month after vaccination | |
| IgG GMFRs | 1 month after vaccination | |
| Percentage of participants with a ≥4-fold rise in serotype-specific OPA titers |
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Inclusion Criteria:
Cohort 1 (Participants ≥15 Months to <2 Years of Age) Healthy toddlers and children ≥15 months to <2 years of age with documentation of prior receipt of PCV.
Cohort 2 (Participants ≥2 Years to <5 Years of Age) Healthy toddlers and children ≥2 years to <5 years of age with documentation of prior receipt of PCV if applicable.
Cohort 3 (Participants ≥5 Years to <18 Years of Age) Healthy children ≥5 years to <18 years of age with documentation of prior receipt of PCV (if applicable). A negative urine pregnancy test is required for individuals of childbearing potential (IOCBP). IOCBP or participants able to father must also agree to use a highly effective method of birth control.
Exclusion Criteria:
All Cohorts (Participants ≥15 Months to <18 Years of Age)
Children with significant medical, psychiatric, or neurological conditions (eg, immunodeficiency or history of seizure); or a history of confirmed invasive pneumococcal infection in the past will be excluded from enrolment in the trial
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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 |
|---|---|---|---|---|---|---|
| Alabama Clinical Therapeutics, LLC Birmingham Pediatric Associates | Recruiting | Birmingham | Alabama | 35205 | United States |
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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) |
|
|
| before to 1 month after vaccination |
| OPA GMFRs | before to 1 month after vaccination |
| Apex Research Group | Recruiting | Fair Oaks | California | 95628 | United States |
| Orange County Research Institute | Recruiting | Ontario | California | 91762 | United States |
| Riveldi and Associates | Not yet recruiting | Miami Lakes | Florida | 33014 | United States |
| Indago Research & Health Center, Inc | Recruiting | Miami Lakes | Florida | 33016 | United States |
| Medical Research Partners | Not yet recruiting | Ammon | Idaho | 83406 | United States |
| Bingham Memorial Hospital | Recruiting | Blackfoot | Idaho | 83221 | United States |
| ASR, LLC | Recruiting | Boise | Idaho | 83702 | United States |
| Kentucky Pediatric/ Adult Research | Recruiting | Bardstown | Kentucky | 40004 | United States |
| Avacare | Not yet recruiting | Covington | Louisiana | 70433 | United States |
| Velocity Clinical Research, Lafayette | Recruiting | Lafayette | Louisiana | 70508 | 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 | Recruiting | Fall River | Massachusetts | 02721 | United States |
| Michigan Center of Medical Research | Recruiting | Bingham Farms | Michigan | 48025 | United States |
| Clinical Research Institute, Inc. | Recruiting | Minneapolis | Minnesota | 55402 | United States |
| Midwest Children's Health Research Institute | Recruiting | Lincoln | Nebraska | 68504 | United States |
| Midwest Children's Health Research Institute | Recruiting | Lincoln | Nebraska | 68505 | United States |
| Midwest Children's Health Research Institute | Recruiting | Lincoln | Nebraska | 68516 | United States |
| Midwest Children's Health Research Institute | Recruiting | Lincoln | Nebraska | 68522 | United States |
| Child Health Care Associates | Not yet recruiting | East Syracuse | New York | 13057 | United States |
| Corning Center for Clinical Research | Recruiting | Horseheads | New York | 14845 | United States |
| Pediatric Associates of Mt. Carmel | Not yet recruiting | Cincinnati | Ohio | 45245 | United States |
| Dayton Clinical Research | Recruiting | Dayton | Ohio | 45409 | United States |
| Senders Pediatrics | Recruiting | South Euclid | Ohio | 44121 | United States |
| Tribe Clinical Research LLC. at Parkside Pediatrics Five Forks | Recruiting | Simpsonville | South Carolina | 29681 | United States |
| Pediatric Clinical Trials of Tennessee, LLC | Not yet recruiting | Tullahoma | Tennessee | 37388 | United States |
| Mercury Clinical Research (Administrative Office) | Recruiting | Houston | Texas | 77054 | United States |
| Kool Kids Pediatrics | Not yet recruiting | Houston | Texas | 77065 | United States |
| Mercury Clinical Research - Pediatric Associates | Recruiting | Houston | Texas | 77087 | United States |
| Neutra Life Sciences | Recruiting | Houston | Texas | 77402 | United States |
| Pediatric Center- Neutra Life Sciences | Recruiting | Richmond | Texas | 77469 | United States |
| Sun Research Institute | Recruiting | San Antonio | Texas | 78215 | United States |
| Victoria Clinical Research Group | Recruiting | Victoria | Texas | 77901 | United States |
| Tanner Clinic - Layton Parkway | Recruiting | Layton | Utah | 84041 | United States |
| Tanner Clinic | Recruiting | Layton | Utah | 84041 | United States |
| AMR Clinical | Recruiting | Provo | Utah | 84604 | United States |
| AMR Clinical | Recruiting | Syracuse | Utah | 84075 | United States |
| Velocity Clinical Research, Salt Lake City | Recruiting | West Jordan | Utah | 84088 | United States |
| Pediatric Research of Charlottesville, LLC | Recruiting | Charlottesville | Virginia | 22902 | United States |
| Clinical Research Partners, LLC | Recruiting | Richmond | Virginia | 23226 | United States |
| BRCR Global Puerto Rico | Recruiting | San Juan | 00907-1509 | Puerto Rico |
| 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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