A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
NCT ID: NCT06524414
Last Updated: 2025-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
605 participants
INTERVENTIONAL
2024-07-25
2027-05-01
Brief Summary
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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:
* male or female infants who are 2 months of age,
* infants born at 36 weeks (about 8 and a half months) of pregnancy or later; and,
* said to be healthy by the study doctor
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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Group 1 PG4
Multivalent Pneumococcal Vaccine
PG4
Multivalent pneumococcal conjugate vaccine
Group 1 20-valent pneumococcal conjugate vaccine (20vPnC)
20-valent pneumococcal conjugate vaccine (20vPnC)
20-valent pneumococcal conjugate vaccine (20vPnC)
20-valent pneumococcal conjugate vaccine
Group 2 PG4
Multivalent Pneumococcal Vaccine
PG4
Multivalent pneumococcal conjugate vaccine
Group 2 20-valent pneumococcal conjugate vaccine (20vPnC)
20-valent pneumococcal conjugate vaccine (20vPnC)
20-valent pneumococcal conjugate vaccine (20vPnC)
20-valent pneumococcal conjugate vaccine
Group 3 PG4
Multivalent Pneumococcal Vaccine
PG4
Multivalent pneumococcal conjugate vaccine
Group 3 20-valent pneumococcal conjugate vaccine (20vPnC)
20-valent pneumococcal conjugate vaccine (20vPnC)
20-valent pneumococcal conjugate vaccine (20vPnC)
20-valent pneumococcal conjugate vaccine
Group 4 PG4
Multivalent Pneumococcal Vaccine
PG4
Multivalent pneumococcal conjugate vaccine
Group 4 15-valent pneumococcal conjugate vaccine (PCV15)
15-valent pneumococcal conjugate vaccine (PCV15)
15-valent pneumococcal conjugate vaccine (PCV15)
15-valent pneumococcal conjugate vaccine
Interventions
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PG4
Multivalent pneumococcal conjugate vaccine
20-valent pneumococcal conjugate vaccine (20vPnC)
20-valent pneumococcal conjugate vaccine
15-valent pneumococcal conjugate vaccine (PCV15)
15-valent pneumococcal conjugate vaccine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
Exclusion Criteria
* Major known congenital malformation or serious chronic disorder.
* Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
* Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
42 Days
98 Days
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Northwest Arkansas Pediatric Clinic
Fayetteville, Arkansas, United States
The Children's Clinic
Jonesboro, Arkansas, United States
Los Ninos Children's Medical Clinic
La Puente, California, United States
Stanford University Medical Center
Palo Alto, California, United States
Los Ninos Children's Medical Clinic
West Covina, California, United States
Velocity Clinical Research, Washington DC
Washington D.C., District of Columbia, United States
Riveldi Biomedical Research and Associates - Miami
Miami Lakes, Florida, United States
Clinical Research Prime
Idaho Falls, Idaho, United States
The Iowa Clinic
Ankeny, Iowa, United States
Cotton O'Neil Pediatrics
Topeka, Kansas, United States
Kentucky Pediatric/ Adult Research
Bardstown, Kentucky, United States
All Children Pediatrics
Louisville, Kentucky, United States
Bluegrass Clinical Research, Inc.
Louisville, Kentucky, United States
LSUHSC Clinical Trials Office
Shreveport, Louisiana, United States
Louisiana State University Health Sciences Shreveport
Shreveport, Louisiana, United States
Ochsner/LSU Health Ambulatory Care Center
Shreveport, Louisiana, United States
University of Maryland
Baltimore, Maryland, United States
UMB/CVD
Frederick, Maryland, United States
Pediatric Associates of Fall River
Fall River, Massachusetts, United States
Boeson Research GTF
Great Falls, Montana, United States
OBGYN Associates
Great Falls, Montana, United States
Boeson Research KAL
Kalispell, Montana, United States
Heart and Hands Midwifery and Family Practice
Kalispell, Montana, United States
POEM Healthcare
Kalispell, Montana, United States
Blue Moose Pediatrics
Missoula, Montana, United States
Boeson Research MSO
Missoula, Montana, United States
Midwest Children's Health Research Institute
Lincoln, Nebraska, United States
Child Health Care Associates
East Syracuse, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Duke Vaccine and Trials Unit
Durham, North Carolina, United States
Durham Pediatrics at North Duke Street
Durham, North Carolina, United States
Dayton Clinical Research
Dayton, Ohio, United States
Ohio Pediatric Research Assn.
Dayton, Ohio, United States
Senders Pediatrics
South Euclid, Ohio, United States
Cyn3rgy Research
Gresham, Oregon, United States
Allegheny Health and Wellness Pavilion
Erie, Pennsylvania, United States
Coastal Pediatric Research
Summerville, South Carolina, United States
Holston Medical Group
Kingsport, Tennessee, United States
Javara - Privia Medical Group North Texas - Dallas
Dallas, Texas, United States
Oak Cliff Research Company, LLC
Dallas, Texas, United States
Oak Cliff Research Company, LLC
Dallas, Texas, United States
PAS Research - McAllen
Edinburg, Texas, United States
Mercury Clinical Research - Pediatric Associates
Houston, Texas, United States
University of Texas Medical Branch
League City, Texas, United States
DCOL Center for Clinical Research
Longview, Texas, United States
Alliance for Multispecialty Research, LLC
Kaysville, Utah, United States
Tanner Clinic - Kaysville
Kaysville, Utah, United States
Alliance for Multispecialty Research, LLC
Layton, Utah, United States
Tanner Clinic
Layton, Utah, United States
AMR Clinical
Murray, Utah, United States
Alliance for Multispecialty Research, LLC
Provo, Utah, United States
AMR Clinical
Roy, Utah, United States
AMR Clinical
South Jordan, Utah, United States
AMR Clinical
Syracuse, Utah, United States
Pediatric Research of Charlottesville, LLC
Charlottesville, Virginia, United States
Clinical Research Puerto Rico
Guayama, , Puerto Rico
Ponce Medical School Foundation Inc.
Ponce, , Puerto Rico
BRCR Global Puerto Rico
San Juan, , Puerto Rico
Caribbean Medical Research Center
San Juan, , Puerto Rico
University of Puerto Rico - Medical Sciences Campus
San Juan, , Puerto Rico
The Hispanic Alliance for Clinical and Translational Research
San Juan, , Puerto Rico
San Miguel Medical
Trujillo Alto, , Puerto Rico
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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NCT06524414
Identifier Type: REGISTRY
Identifier Source: secondary_id
2025-000081-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C4931002
Identifier Type: -
Identifier Source: org_study_id
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