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| ID | Type | Description | Link |
|---|---|---|---|
| C4931010-OPENLABEL | Other Identifier | Alias Study Number |
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The purpose of this study is to learn about the safety, tolerability and immune effects of a pneumococcal vaccine in toddlers.
Participants will take part in this study for approximately 6 or 8 months depending on which group they are assigned to. During this time participants will have 2 clinic visits and 1 phone visit for the 1-Dose group, or 3 clinic visits and 1 phone visit for the 2-Dose group.
At these clinic visits, participants will be asked if any side effects were experienced. The participants will also have to give blood samples during some clinic visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PG4 1-Dose Group | Experimental | Participants to receive a single injection of Multivalent Pneumococcal Vaccine |
|
| PG4 2-Dose Group | Experimental | Participants to receive two injections of Multivalent Pneumococcal Vaccine |
|
| 20-valent pneumococcal conjugate vaccine (20vPnC) | Active Comparator | Participants to receive a single injection of 20-valent pneumococcal conjugate vaccine (20vPnC). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PG4 | Biological | Multivalent pneumococcal conjugate vaccine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants reporting prespecified local reactions within 7 days after each dose | Prespecified local reactions (redness, swelling, and pain at the injection site) after each dose | 7 days after each dose |
| Percentage of participants reporting prespecified systemic events within 7 days after each dose | Prespecified systemic events (fever, decreased appetite, drowsiness/increased sleep, and irritability) after each dose | 7 days after each dose |
| Percentage of participants reporting Adverse Events (AEs) within 1 month after the last assigned vaccination | Adverse events occurring within 1 month after the last assigned vaccination | From signing of ICD to 1 month after last assigned vaccination |
| Percentage of participants reporting Serious Adverse Events (SAEs) within 6 months after vaccination | SAEs occurring from Dose 1 through 6 months after the last assigned vaccination | From signing of ICD to 6 months after last assigned vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Pneumococcal serotype specific IgG concentrations | Pneumococcal IgG GMCs 1 month after the last assigned vaccination | 1 month after last assigned vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emerson Clinical Research Institute | Washington D.C. | District of Columbia | 20009 | United States | ||
| Bio-Medical Research 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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Study is partially blinded as 2 of the 3 groups are blinded and 1 is unblinded.
| 20-valent pneumococcal conjugate vaccine (20vPnC) | Biological | 20-valent pneumococcal conjugate vaccine (20vPnC) |
|
|
| Miami |
| Florida |
| 33144 |
| United States |
| Tekton Research, LLC. | Chamblee | Georgia | 30341 | United States |
| Javara - Privia Medical Group Georgia - Fayetteville | Fayetteville | Georgia | 30214 | United States |
| Rophe Adult and Pediatric Medicine/SKYCRNG | Union City | Georgia | 30291 | United States |
| The Iowa Clinic | Ankeny | Iowa | 50023 | United States |
| Louisiana State University Health Sciences Shreveport - Fairfield avenue | Shreveport | Louisiana | 71101 | United States |
| Louisiana State University Health Sciences Shreveport | Shreveport | Louisiana | 71103 | United States |
| Ochsner/LSU Health Ambulatory Care Center | Shreveport | Louisiana | 71103 | United States |
| University of Maryland, Baltimore - Institutional Review Board | Baltimore | Maryland | 21201 | United States |
| University of Maryland, Baltimore, Center for Vaccine Development and Global Health | Baltimore | Maryland | 21201 | United States |
| The Pediatric Center | Columbia | Maryland | 21045 | United States |
| Atrium Health - Strive Vaccine Research Clinic | Charlotte | North Carolina | 28207 | United States |
| Atrium Health-Myers Park | Charlotte | North Carolina | 28207 | United States |
| Duke Vaccine and Trials Unit | Durham | North Carolina | 27703 | United States |
| Durham Pediatrics at North Duke Street | Durham | North Carolina | 27704 | United States |
| Duke University | Durham | North Carolina | 27705 | United States |
| Atrium Health-Matthews | Matthews | North Carolina | 28105 | United States |
| Senders Pediatrics | South Euclid | Ohio | 44121 | United States |
| Carolina Family Care | Charleston | South Carolina | 29414 | United States |
| MUSC Children's Health | Charleston | South Carolina | 29414 | United States |
| Carolina Family Care | Summerville | South Carolina | 29486 | United States |
| MUSC Children's Health | Summerville | South Carolina | 29486 | United States |
| Holston Medical Group | Kingsport | Tennessee | 37660 | United States |
| Pediatric Clinical Trials of Tennessee, LLC | Tullahoma | Tennessee | 37388 | United States |
| Javara - Privia Medical Group North Texas - Dallas | Dallas | Texas | 75230 | United States |
| Oak Cliff Research Company, LLC | Dallas | Texas | 75252 | United States |
| Oak Cliff Research Company, LLC | Dallas | Texas | 75287 | United States |
| Mercury Clinical Research - Houston | Houston | Texas | 77054 | United States |
| DM Clinical Research - Kool Kids Pediatrics | Houston | Texas | 77065 | United States |
| Kool Kids Pediatrics | Houston | Texas | 77065 | United States |
| Mercury Clinical Research - Sunrise Pediatrics | Houston | Texas | 77077 | United States |
| Mercury Clinical Research - Pediatric Associates | Houston | Texas | 77087 | United States |
| University of Texas Medical Branch | League City | Texas | 77573 | United States |
| Mercury Clinical Research - North Houston Internal Medicine & Pediatric Clinic | Tomball | Texas | 77375 | United States |
| Ponce Medical School Foundation Inc. | Ponce | 00716 | Puerto Rico |
| BRCR Medical Center - Ponce | Ponce | 00717 | Puerto Rico |
| BRCR Global Puerto Rico | San Juan | 00907-1509 | Puerto Rico |
| CMRC Headlands, LLC | San Juan | 00918 | 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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