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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. It will also assess how the new vaccine works in comparison to the one that is currently in use when given with other childhood vaccines.
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 infants. Pneumococcal disease includes a variety of infections caused by a specific germ, Streptococcus pneumoniae.
There are three groups in this study. All participants will be assigned to one of the three groups. This study is seeking participants who are:
About 3000 infants will be assigned to Group 1. The infants in this group will have a 1 in 2 chance (50%) of receiving 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.
About 140 infants from outside the United States will be assigned to Group 2. The infants in this group will have a 1 in 2 chance (50%) of receiving either PG4 or 20vPnC into the left thigh muscle at 2 to 6, 3 to 8, 4 to 10, and 12 to 15 months of age.
About 90 infants from outside the United States will be assigned to Group 3. The infants in Group 3 will have a 1 in 3 chance (33%) of receiving either PG4 into the left thigh muscle, PG4 under the skin of the left thigh, or 20vPnC into the left thigh muscle at 2 to 6, 3 to 8, 4 to 10, and 12 to 15 months of age.
Infants in Group 1 will take part in this study for about 16 to 19 months (about 1 and a half years). Infants in Groups 2 and 3 will take part in this study for 12 to 21 months (about 1 to 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. Infants will have 3 blood samples collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 PG4 (intramuscular) | Experimental | Multivalent Pneumococcal Vaccine |
|
| Group 1 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular) | Active Comparator | 20-valent pneumococcal conjugate vaccine (20vPnC) |
|
| Group 2 PG4 (intramuscular) | Experimental | Multivalent Pneumococcal Vaccine |
|
| Group 2 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular) | Active Comparator | 20-valent pneumococcal conjugate vaccine (20vPnC) |
|
| Group 3 PG4 (intramuscular) | Experimental | Multivalent Pneumococcal Vaccine |
|
| Group 3 PG4 (subcutaneous) | Experimental |
| 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 |
| Differences in percentages of participants with predefined pneumococcal specific immunoglobulin G (IgG) concentrations 1 month after Dose 3 | Differences in pneumococcal immunoglobulin G (IgG) concentrations 1 month after Dose 3 | 1 month after Dose 3 |
| Pneumococcal IgG geometric mean concentrations (GMCs) 1 month after Dose 4 | Pneumococcal IgG GMCs 1 month after Dose 4 | 1 month after Dose 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Pneumococcal IgG GMCs 1 month after Dose 3 | Pneumococcal IgG GMCs 1 month after Dose 3 | 1 month after Dose 3 |
| Percentage of participants with serotype 3 specific predefined pneumococcal IgG concentrations 1 month after Dose 3 |
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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 |
|---|---|---|---|---|---|---|
| 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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Multivalent Pneumococcal Vaccine
|
| Group 3 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular) | Active Comparator | 20-valent pneumococcal conjugate vaccine (20vPnC) |
|
| 20-valent pneumococcal conjugate vaccine (20vPnC) | Biological | 20-valent pneumococcal conjugate vaccine (20vPnC) |
|
|
Pneumococcal serotype 3 IgG concentrations 1 month after Dose 3
| 1 month after Dose 3 |
| Pneumococcal serotype 3 IgG GMCs 1 month after Dose 4 | Pneumococcal serotype 3 IgG GMCs 1 month after Dose 4 | 1 month after Dose 4 |
| Differences in percentages of participants with predefined pneumococcal serotype 6C and 15C immunoglobulin G (IgG) concentrations 1 month after Dose 3 | Differences in pneumococcal serotype 6C and 15C immunoglobulin G (IgG) concentrations 1 month after Dose 3 | 1 month after Dose 3 |
| Pneumococcal serotype 6C and 15C IgG GMCs and GMRs 1 month after Dose 4 | Pneumococcal serotype 6C and 15C IgG GMCs and GMRs 1 month after Dose 4 | 1 month after Dose 4 |
| Pneumococcal opsonophagocytic activity (OPA) titers 1 month after Dose 3 | Pneumococcal OPA titers 1 month after Dose 3 | 1 month after Dose 3 |
| Pneumococcal OPA titers prior to Dose 4 | Pneumococcal OPA titers prior to Dose 4 | Prior to Dose 4 |
| Pneumococcal OPA titers 1 month after Dose 4 | Pneumococcal OPA titers 1 month after Dose 4 | 1 month after Dose 4 |
| Percentage of participants with predefined pneumococcal specific IgG concentrations 1 month after Dose 4 | Percentage of participants with predefined pneumococcal specific IgG concentrations 1 month after Dose 4 | 1 month after Dose 4 |
| Pneumococcal IgG concentrations 1 month after Dose 3 | Pneumococcal IgG concentrations 1 month after Dose 3 | 1 month after Dose 3 |
| Pneumococcal IgG concentrations prior to Dose 4 | Pneumococcal IgG concentrations prior to Dose 4 | Prior to Dose 4 |
| Pneumococcal IgG concentrations 1 month after Dose 4 | Pneumococcal IgG concentrations 1 month after Dose 4 | 1 month after Dose 4 |
| IgG geometric mean fold rise (GMFR) from before Dose 4 to 1 month after Dose 4 | IgG GMFR from before Dose 4 to 1 month after Dose 4 | Before Dose 4 to 1 month after Dose 4 |
| IgG GMFR from 1 month after Dose 3 to 1 month after Dose 4 | IgG GMFR from 1 month after Dose 3 to 1 month after Dose 4 | From 1 month after Dose 3 to 1 month after Dose 4 |
| Percentages of participants with prespecified antibody levels to specific concomitant vaccine antigens 1 month after Dose 3 | Prespecified antibody levels to specific concomitant vaccine antigens 1 month after Dose 3 | 1 month after Dose 3 |
| Geometric mean of antibody levels to measles, mumps, rubella, varicella, and hepatitis A virus antigens 1 month after Dose 4 | Geometric mean of antibody levels to measles, mumps, rubella, varicella, and hepatitis A virus antigens 1 month after Dose 4 | 1 month after Dose 4 |
| Geometric mean of immunoglobulin A (IgA) antibody levels to rotavirus 1 month after Dose 3 | Geometric mean of IgA antibody levels to rotavirus 1 month after Dose 3 | 1 month after Dose 3 |
| University of Alabama at Birmingham - School of Medicine | Not yet recruiting | Birmingham | Alabama | 35233 | United States |
| KUR Research, LLC | Not yet recruiting | Centreville | Alabama | 35042 | United States |
| Northwest Arkansas Pediatric Clinic | Recruiting | Fayetteville | Arkansas | 72703 | United States |
| The Children's Clinic of Jonesboro, P.A. | Recruiting | Jonesboro | Arkansas | 72401 | United States |
| Helios Clinical Research | Not yet recruiting | Sherwood | Arkansas | 72120 | United States |
| San Gabriel Woman's Health | Recruiting | Arcadia | California | 91007 | United States |
| Family Medical Clinic | Recruiting | El Monte | California | 91731 | United States |
| Clinical Research of Central California | Recruiting | Fresno | California | 93704 | United States |
| SeraCollection Research Services, LLC | Recruiting | Montebello | California | 90640 | United States |
| Bailony Pediatrics | Not yet recruiting | National City | California | 91950 | United States |
| Stanford University Medical Center | Not yet recruiting | Palo Alto | California | 94304 | United States |
| Childrens Hospital of Colorado | Recruiting | Aurora | Colorado | 80045 | United States |
| Direct Helpers Research Center | Recruiting | Hialeah | Florida | 33012 | United States |
| C & R Research Services USA | Recruiting | Homestead | Florida | 33030 | United States |
| Florida Pharmaceutical Research and Associates, Inc. | Recruiting | Miami | Florida | 33143 | United States |
| Bioresearch Partner | Recruiting | Miami | Florida | 33155 | United States |
| Gold Coast Health Research Center, LLC | Recruiting | Miami | Florida | 33155 | United States |
| Dade Research Center | Not yet recruiting | Miami | Florida | 33173 | United States |
| Vasconcello-Cohen MD Research, LLC. | Not yet recruiting | Miami | Florida | 33183 | United States |
| Riveldi and Associates | Recruiting | Miami Lakes | Florida | 33014 | United States |
| Eminent Clinical Research and Associates | Recruiting | North Lauderdale | Florida | 33068 | United States |
| Cordova Research Institute LLC | Recruiting | Sweetwater | Florida | 33182 | United States |
| Altruistic Clinical Research Global | Recruiting | Norcross | Georgia | 30093 | United States |
| Medical Research Partners | Recruiting | Ammon | Idaho | 83406 | United States |
| Bingham Memorial Hospital | Recruiting | Blackfoot | Idaho | 83221 | United States |
| ASR, LLC | Recruiting | Boise | Idaho | 83702 | United States |
| Leavitt Clinical Research | Not yet recruiting | Idaho Falls | Idaho | 83404 | United States |
| MidValley Research, Inc | Recruiting | Moline | Illinois | 61265 | United States |
| The Iowa Clinic. | Not yet recruiting | Ankeny | Iowa | 50023 | United States |
| Eximia Research - IA, LLC (dba Integrated Clinical Trial Services, LLC) | Recruiting | West Des Moines | Iowa | 50265 | United States |
| Integrity Clinical Network, LLC | Recruiting | Derby | Kansas | 67037 | United States |
| ACC Pediatric Research | Recruiting | Haughton | Louisiana | 71037 | United States |
| Kur Research, LLC | Recruiting | Columbia | Maryland | 21045 | United States |
| Michigan Institute of Research | Recruiting | Allen Park | Michigan | 48101 | United States |
| Michigan Center of Medical Research | Recruiting | Bingham Farms | Michigan | 48025 | United States |
| Vida Clinical Studies, LLC | Recruiting | Dearborn Heights | Michigan | 48127 | United States |
| Velocity Clinical Research, Grand Island | Recruiting | Grand Island | Nebraska | 68803 | 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 | Recruiting | East Syracuse | New York | 13057 | United States |
| University of Rochester Medical Center | Recruiting | Rochester | New York | 14642 | United States |
| Atrium Health Cannon Research Cente | Recruiting | Charlotte | North Carolina | 28203 | United States |
| Atrium Health - STRIVE Research clinic | Recruiting | Charlotte | North Carolina | 28207 | United States |
| Atrium Health Levine Children's Myers Park Pediatrics | Recruiting | Charlotte | North Carolina | 28207 | United States |
| Duke Vaccine and Trials Unit | Recruiting | Durham | North Carolina | 27703 | United States |
| Durham Pediatrics at North Duke Street | Recruiting | Durham | North Carolina | 27704 | United States |
| Atrium Health Levine Children's Charlotte Pediatrics | Recruiting | Matthews | North Carolina | 28105 | United States |
| Atrium Health STRIVE Research Clinic - Matthews | Recruiting | Matthews | North Carolina | 28105 | United States |
| Wilmington Health | Not yet recruiting | Wilmington | North Carolina | 28405 | United States |
| Pediatric Associates of Mt. Carmel | Recruiting | Cincinnati | Ohio | 45245 | United States |
| PriMED Clinical Research | Recruiting | Dayton | Ohio | 45429 | United States |
| Senders Pediatrics | Recruiting | South Euclid | Ohio | 44121 | United States |
| Allegheny Health and Wellness Pavilion | Not yet recruiting | Erie | Pennsylvania | 16506 | United States |
| Tribe Clinical Research LLC. at Parkside Pediatrics Harrison Bridge Road | Recruiting | Simpsonville | South Carolina | 29680 | United States |
| Pediatric Clinical Trials of Tennessee, LLC | Not yet recruiting | Tullahoma | Tennessee | 37388 | United States |
| Proactive RGV | Recruiting | Brownsville | Texas | 78520 | United States |
| Proactive Clinical Research LLC | Recruiting | Edinburg | Texas | 78539 | United States |
| Proactive El Paso,LLC | Not yet recruiting | El Paso | Texas | 79902 | United States |
| University of Texas Medical Branch, Sealy Institute for Vaccine Sciences Clinical Trials Program | Not yet recruiting | Galveston | Texas | 77555 | United States |
| Neutra Life Sciences | Recruiting | Houston | Texas | 77042 | United States |
| Mercury Clinical Research (Administrative Office) | Recruiting | Houston | Texas | 77054 | United States |
| Kool Kids Pediatrics | Recruiting | Houston | Texas | 77065 | United States |
| Aavon Clinical Trials, LLC. | Not yet recruiting | Houston | Texas | 77074 | United States |
| Mercury Clinical Research - Sunrise Pediatrics | Recruiting | Houston | Texas | 77077 | United States |
| Mercury Clinical Research - Pediatric Associates | Recruiting | Houston | Texas | 77087 | United States |
| Houston Clinical Research Associates | Not yet recruiting | Houston | Texas | 77090 | United States |
| Prime Clinical Research - Lewisville | Recruiting | Lewisville | Texas | 75067 | United States |
| Prime Clinical Research - Mansfield | Recruiting | Mansfield | Texas | 76063 | United States |
| Dr. Ruben Aleman & Associates | Not yet recruiting | McAllen | Texas | 78504 | United States |
| SMS Clinical Research LLC | Recruiting | Mesquite | Texas | 75149 | United States |
| Pediatric Center- Neutra Life Sciences | Recruiting | Richmond | Texas | 77469 | United States |
| Sun Research Institute | Not yet recruiting | San Antonio | Texas | 78215 | United States |
| AMR Clinical | Recruiting | Provo | Utah | 84604 | United States |
| AMR Clinical | Recruiting | Syracuse | Utah | 84075 | United States |
| Clinical Research Partners, LLC | Recruiting | Richmond | Virginia | 23226 | United States |
| Tekton Research, LLC. | Recruiting | Richmond | Virginia | 23233 | United States |
| TOYOTA Memorial Hospital | Recruiting | Toyota-shi | Aichi-ken | 471-8513 | Japan |
| Shindo children's clinic | Recruiting | Fukuoka | Fukuoka | 814-0121 | Japan |
| Yokoyama Children'S Clinic | Recruiting | Kasuga | Fukuoka | 816-0801 | Japan |
| Ohigesenseino Kodomo Clinic | Recruiting | Sapporo | Hokkaido | 062-0907 | Japan |
| Nintenkaikagoshima Children's Hospital | Recruiting | Hioki | Kagoshima-ken | 899-2503 | Japan |
| Futaba Clinic | Recruiting | Shinjuku-ku | Tokyo | 160-0017 | Japan |
| Kose Children Clinic | Recruiting | Kofu | Yamanashi | 400-0853 | Japan |
| Fukui Aiiku Hospital | Recruiting | Fukui | 910-0833 | Japan |
| Fukazawa Pediatric Clinic | Recruiting | Fukuoka | 813-0036 | Japan |
| Kubota Children's Clinic | Recruiting | Osaka | 544-0033 | Japan |
| Clinical Research Investigator Group | Recruiting | Bayamón | 00960 | Puerto Rico |
| Caguas Clinical Research | Recruiting | Caguas | 00725 | Puerto Rico |
| San Juan Bautista School of Medicine - Clinical Research Unit | Not yet recruiting | Caguas | 00726 | Puerto Rico |
| Clinical Research Puerto Rico | Recruiting | Guayama | 00784 | Puerto Rico |
| Ponce Medical School Foundation Inc./ CAIMED Center | Recruiting | Ponce | 00716 | Puerto Rico |
| BRCR Global Puerto Rico | Recruiting | Ponce | 00717 | Puerto Rico |
| BRCR Global Puerto Rico | Recruiting | San Juan | 00907 | Puerto Rico |
| San Miguel Medical | Recruiting | Trujillo Alto | 00976-3910 | 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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