A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
- Conditions
- Pneumococcal Disease
- Interventions
- Biological: 20-valent pneumococcal conjugate vaccine (20vPnC)Biological: 15-valent pneumococcal conjugate vaccine (PCV15)
- Registration Number
- NCT06524414
- Lead Sponsor
- Pfizer
- Brief Summary
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:
* 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 800
- Male or female infants born at >36 weeks of gestation and 2 months of age at the time of consent.
- Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 PG4 PG4 Multivalent Pneumococcal Vaccine Group 4 PG4 PG4 Multivalent Pneumococcal Vaccine Group 1 20-valent pneumococcal conjugate vaccine (20vPnC) 20-valent pneumococcal conjugate vaccine (20vPnC) 20-valent pneumococcal conjugate vaccine (20vPnC) Group 2 PG4 PG4 Multivalent Pneumococcal Vaccine Group 2 20-valent pneumococcal conjugate vaccine (20vPnC) 20-valent pneumococcal conjugate vaccine (20vPnC) 20-valent pneumococcal conjugate vaccine (20vPnC) Group 3 PG4 PG4 Multivalent Pneumococcal Vaccine Group 3 20-valent pneumococcal conjugate vaccine (20vPnC) 20-valent pneumococcal conjugate vaccine (20vPnC) 20-valent pneumococcal conjugate vaccine (20vPnC) Group 4 15-valent pneumococcal conjugate vaccine (PCV15) 15-valent pneumococcal conjugate vaccine (PCV15) 15-valent pneumococcal conjugate vaccine (PCV15)
- Primary Outcome Measures
Name Time Method Percentage of participants reporting systemic events within 7 days after each dose Day 7 Prompted systemic reactions after each dose
Percentage of participants reporting adverse events (AEs) Dose 1 to 1 month after Dose 3 AEs occurring from Dose 1 to 1 month after Dose 2
Percentage of participants reporting AEs Dose 4 to 1 month after Dose 4 AEs occurring from Dose 4 to 1 month after Dose 4
Percentage of participants reporting serious adverse events (SAEs) Dose 1 to 6 months after Dose 4 SAEs occurring from Dose 1 to 6 months after Dose 4
Percentage of participants reporting local reactions within 7 days after each dose Day 7 Prompted local reactions after each dose
- Secondary Outcome Measures
Name Time Method Pneumococcal immunoglobulin G (IgG) geometric mean concentrations (GMCs) 1 month after Dose 4 Pneumococcal IgG GMCs 1 month after Dose 4
Trial Locations
- Locations (49)
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
Northwest Arkansas Pediatric Clinic
🇺🇸Fayetteville, Arkansas, United States
Los Ninos Children's Medical Clinic
🇺🇸West Covina, California, United States
Kaiser Permanente South Sacramento
🇺🇸Sacramento, California, United States
The Children's Clinic
🇺🇸Jonesboro, Arkansas, United States
Kaiser Permanente Daly City
🇺🇸Daly City, California, United States
Kaiser Permanente San Jose
🇺🇸San Jose, California, United States
Private Practice - Dr. Carey Chronis
🇺🇸Ventura, California, United States
Kaiser Permanente Walnut Creek
🇺🇸Walnut Creek, California, United States
Riveldi Biomedical Research and Associates - Miami
🇺🇸Miami Lakes, Florida, United States
Clinical Research Prime
🇺🇸Idaho Falls, Idaho, United States
Clinical Research Prime Rexburg
🇺🇸Rexburg, 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
Midwest Children's Health Research Institute
🇺🇸Lincoln, Nebraska, United States
Child Health Care Associates
🇺🇸East Syracuse, 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
PAS Research - McAllen
🇺🇸Edinburg, Texas, United States
Pediatric Associates
🇺🇸Houston, Texas, United States
Houston Clinical Research 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
🇺🇸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