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| ID | Type | Description | Link |
|---|---|---|---|
| NCT06524414 | Registry Identifier | ClinicalTrials.gov | |
| 2025-000081-28 | EudraCT Number |
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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 in infants when compared to the pneumococcal vaccines that are currently in use, 20vPnC (Prevnar 20®) or another licensed pneumococcal vaccine.
To ensure that the new vaccine (PG4) stays stable, it is placed in a liquid mixture of sterile water and other substances (a solution). This study will also test if there is a difference in the safety and immune effects of the new pneumococcal vaccine when it is one type of solution compared to when it is in a different type of solution.
The immune response is how the body's cells; tissues and organs work together to protect the body from infection. Blood samples will be used to measure the amount of antibodies produced after the vaccination. Antibodies are proteins that protect you when an unwanted germ enters the body. This will help understand how well the new pneumococcal vaccine works. This vaccine can possibly provide protection against pneumococcal disease. Pneumococcal disease includes a variety of infections caused by a specific germ, Streptococcus pneumoniae.
This study is seeking participants who are:
There are four groups in this study. All participants will be assigned to one of the four groups. All study vaccines will be given as a single shot into the left thigh muscle. Participants in the three groups will have 3 blood samples collected during the 1 and a half years they are in the study.
The first 400 participants who enter the study will be assigned to either Group 1 or Group 2. Half the participants in Group 1 and half the participants in Group 2 will receive 4 doses at 2, 4, 6, and 12 to 15 months of age of PG4 mixed in the first solution. The other half of the participants in Groups 1 and 2 will receive 4 doses of 20vPnC (Prevnar 20®) at 2, 4, 6, and 12 to 15 months of age. The main difference between Groups 1 and 2 is that participants in Group 2 will have the first blood sample collected at an earlier time than those in Group 1.
Once 400 participants have been assigned to Groups 1 and 2 then 100 new participants will be assigned to Group 3. Half the participants in Group 3 will receive PG4 in the second solution at 2, 4, 6, and 12 to 15 months of age. The other half of the participants in Groups 3 will receive 4 doses of 20vPnC (Prevnar 20®) at 2, 4, 6, and 12 to 15 months of age.
Once the 100 participants have been assigned to Group 3 then 300 new participants will be assigned to Group 4. Half the participants in Group 4 will receive PG4 in the first solution at 2, 4, 6, and 12 to 15 months of age. The other half of the participants in Group 4 will receive 4 doses of a licensed pneumococcal comparator vaccine at 2, 4, 6, and 12 to 15 months of age.
Participants will take part in this study for about 16 to 19 months (about 1 and a half years). During this time, participants will have 6 study clinic visits and 1 to 2 phone calls. At these study clinic visits, parent(s) or legal guardian(s) will be asked if the participant 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 |
|---|---|---|---|
| Group 1 PG4 | Experimental | Multivalent Pneumococcal Vaccine |
|
| Group 1 20-valent pneumococcal conjugate vaccine (20vPnC) | Active Comparator | 20-valent pneumococcal conjugate vaccine (20vPnC) |
|
| Group 2 PG4 | Experimental | Multivalent Pneumococcal Vaccine |
|
| Group 2 20-valent pneumococcal conjugate vaccine (20vPnC) | Active Comparator | 20-valent pneumococcal conjugate vaccine (20vPnC) |
|
| Group 3 PG4 | Experimental | Multivalent Pneumococcal Vaccine |
|
| Group 3 20-valent pneumococcal conjugate vaccine (20vPnC) | Active Comparator | 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 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 reactions after each dose | Day 7 |
| Percentage of participants reporting adverse events (AEs) | AEs occurring from Dose 1 to 1 month after Dose 2 | Dose 1 to 1 month after Dose 3 |
| Percentage of participants reporting AEs | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pneumococcal immunoglobulin G (IgG) geometric mean concentrations (GMCs) | Pneumococcal IgG GMCs 1 month after Dose 4 | 1 month after Dose 4 |
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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 |
|---|---|---|---|---|---|---|
| Northwest Arkansas Pediatric Clinic | Fayetteville | Arkansas | 72703 | United States | ||
| The Children's Clinic |
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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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|
| Group 4 PG4 | Experimental | Multivalent Pneumococcal Vaccine |
|
| Group 4 15-valent pneumococcal conjugate vaccine (PCV15) | Active Comparator | 15-valent pneumococcal conjugate vaccine (PCV15) |
|
| 20-valent pneumococcal conjugate vaccine (20vPnC) | Biological | 20-valent pneumococcal conjugate vaccine |
|
|
| 15-valent pneumococcal conjugate vaccine (PCV15) | Biological | 15-valent pneumococcal conjugate vaccine |
|
|
| Jonesboro |
| Arkansas |
| 72401 |
| United States |
| Los Ninos Children's Medical Clinic | La Puente | California | 91744 | United States |
| Los Ninos Children's Medical Clinic | West Covina | California | 91790 | United States |
| Velocity Clinical Research, Washington DC | Washington D.C. | District of Columbia | 20016 | United States |
| Riveldi Biomedical Research and Associates - Miami | Miami Lakes | Florida | 33014 | United States |
| Clinical Research Prime | Idaho Falls | Idaho | 83404 | United States |
| The Iowa Clinic | Ankeny | Iowa | 50023 | United States |
| Cotton O'Neil Pediatrics | Topeka | Kansas | 66604 | United States |
| Kentucky Pediatric/ Adult Research | Bardstown | Kentucky | 40004 | United States |
| All Children Pediatrics | Louisville | Kentucky | 40243 | United States |
| Bluegrass Clinical Research, Inc. | Louisville | Kentucky | 40291 | United States |
| LSUHSC Clinical Trials Office | 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 | Maryland | 21201 | United States |
| UMB/CVD | Frederick | Maryland | 21702 | United States |
| Pediatric Associates of Fall River | Fall River | Massachusetts | 02721 | United States |
| Boeson Research GTF | Great Falls | Montana | 59405 | United States |
| OBGYN Associates | Great Falls | Montana | 59405 | United States |
| Origin Health | Great Falls | Montana | 59405 | United States |
| Boeson Research KAL | Kalispell | Montana | 59901 | United States |
| Heart and Hands Midwifery and Family Practice | Kalispell | Montana | 59901 | United States |
| POEM Healthcare | Kalispell | Montana | 59901 | United States |
| Blue Moose Pediatrics | Missoula | Montana | 59804 | United States |
| Boeson Research Laboratory | Missoula | Montana | 59804 | United States |
| Boeson Research MSO | Missoula | Montana | 59804 | United States |
| Midwest Children's Health Research Institute | Lincoln | Nebraska | 68522 | United States |
| Child Health Care Associates | East Syracuse | New York | 13057 | United States |
| University of Rochester | Rochester | New York | 14611 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Velocity Clinical Research Inc. | Durham | North Carolina | 27701 | 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 |
| Javara Inc a Delaware corporation | Winston-Salem | North Carolina | 27101 | United States |
| Dayton Clinical Research | Dayton | Ohio | 45409 | United States |
| Ohio Pediatric Research Assn. | Dayton | Ohio | 45414 | United States |
| Senders Pediatrics | South Euclid | Ohio | 44121 | United States |
| Cyn3rgy Research | Gresham | Oregon | 97030 | United States |
| Allegheny Health and Wellness Pavilion | Erie | Pennsylvania | 16506 | United States |
| Square-1 Clincal Research | Erie | Pennsylvania | 16506 | United States |
| Coastal Pediatric Research | Summerville | South Carolina | 29486 | United States |
| Holston Medical Group | Kingsport | Tennessee | 37660 | United States |
| Javara - Privia Medical Group North Texas - Dallas | Dallas | Texas | 75230 | United States |
| Oak Cliff Research Company, LLC | Dallas | Texas | 75287 | United States |
| PAS Research - McAllen | Edinburg | Texas | 78539 | United States |
| Mercury clinical research Inc. | Houston | Texas | 77054 | United States |
| Mercury Clinical Research - Pediatric Associates | Houston | Texas | 77087 | United States |
| University of Texas Medical Branch | League City | Texas | 77573 | United States |
| DCOL Center for Clinical Research | Longview | Texas | 75605 | United States |
| AMR Clinical | Kaysville | Utah | 84037 | United States |
| Tanner Clinic - Kaysville | Kaysville | Utah | 84037 | United States |
| Alliance for Multispecialty Research, LLC | Layton | Utah | 84041 | United States |
| Tanner Clinic | Layton | Utah | 84041 | United States |
| Tanner Memorial Clinic | Layton | Utah | 84041 | United States |
| AMR Clinical | Murray | Utah | 84107 | United States |
| AMR Clinical | Provo | Utah | 84604 | United States |
| AMR Clinical | Roy | Utah | 84067 | United States |
| AMR Clinical | South Jordan | Utah | 84095 | United States |
| AMR Clinical | Syracuse | Utah | 84075 | United States |
| Pediatric Research of Charlottesville, LLC | Charlottesville | Virginia | 22902 | United States |
| San Miguel Medical | Trujillo Alto | PR | 00976 | Puerto Rico |
| Clinical Research Puerto Rico | Guayama | 00784 | Puerto Rico |
| Ponce Medical School Foundation Inc. | Ponce | 00716 | Puerto Rico |
| BRCR Global Puerto Rico | San Juan | 00907-1509 | Puerto Rico |
| CMRC Headlands, LLC | San Juan | 00918 | Puerto Rico |
| University of Puerto Rico - Medical Sciences Campus | San Juan | 00935-6528 | Puerto Rico |
| The Hispanic Alliance for Clinical and Translational Research | San Juan | 00935 | 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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