PG4
BiologicalMultivalent Pneumococcal Vaccine
NCT Number: NCT07660198
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 children 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. 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 children. Pneumococcal disease includes a variety of infections caused by a specific germ, Streptococcus pneumoniae
This study is seeking participants who:
* Are children aged 15 months to 18 years. * May or may not have received any doses of pneumococcal conjugate vaccine (PCV) in the past.
The study will be conducted in the United States, Puerto Rico, and other countries.
Participants will be assigned to 1 of 3 groups based on age:
Group 1: 15 months to less than 2 years (about 300 participants) Group 2: 2 years to less than 5 years (about 300 participants) Group 3: 5 years to less than 18 years (about 600 participants)
Within each group, participants will be assigned by chance in a 2:1 ratio to receive 1 vaccine injection (shot) with either PG4 (new vaccine) or 20vPnC, given in the arm or thigh. This means that for every 3 participants, about 2 will receive PG4 and about 1 will receive 20vPnC.
Each participant will take part in the study for approximately 6 months. During this time, each participant will visit a clinic 2 times (visit 1 for vaccination and visit 2 to follow up) and will be contacted via telephone once (for a 6 month follow up).
At the study clinic visits, participants will have their blood drawn and be asked if they have experienced any side effects. A side effect is an unintentional or unexpected reaction to a vaccine. During the 6-month follow-up contact, participants will be asked about any further side effects.
Interested in participating?
Request Info15 month–17 year
All sexes
Interventional
Phase 3
BRCR Global Puerto Rico, San Juan, Puerto Rico
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Cohort 1 (Participants ≥15 Months to <2 Years of Age) Healthy toddlers and children ≥15 months to <2 years of age with documentation of prior receipt of PCV.
Cohort 2 (Participants ≥2 Years to <5 Years of Age) Healthy toddlers and children ≥2 years to <5 years of age with documentation of prior receipt of PCV if applicable.
Cohort 3 (Participants ≥5 Years to <18 Years of Age) Healthy children ≥5 years to <18 years of age with documentation of prior receipt of PCV (if applicable). A negative urine pregnancy test is required for individuals of childbearing potential (IOCBP). IOCBP or participants able to father must also agree to use a highly effective method of birth control.
Exclusion criteria
All Cohorts (Participants ≥15 Months to <18 Years of Age)
Children with significant medical, psychiatric, or neurological conditions (eg, immunodeficiency or history of seizure); or a history of confirmed invasive pneumococcal infection in the past will be excluded from enrolment in the trial
Multivalent Pneumococcal Vaccine
20-valent pneumococcal conjugate vaccine (20vPnC)
Other names: Prevnar 20
Time frame: Within 7 days after Vaccination
Time frame: Within 7 days after Vaccination
Time frame: From Vaccination to 1 month after Vaccination
Time frame: From Vaccination to 6 months after Vaccination
Time frame: 1 month after vaccination
Time frame: 1 month after vaccination
Time frame: 1 month after vaccination
Time frame: 1 month after vaccination
Time frame: before to 1 month after vaccination
Time frame: before to 1 month after vaccination
Contact information is provided by the study sponsor or research team.
Pfizer
Industry
A PHASE 3, RANDOMIZED DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A CATCH-UP VACCINATION REGIMEN OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY CHILDREN AND ADOLESCENTS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07573462
Bacterial Infections, Bacterial Infections and Mycoses
Estero, Florida, United States
View Trial DetailsNCT07135453
Bacterial Infections, Bacterial Infections and Mycoses
Birmingham, Alabama, United States
View Trial DetailsNCT07629440
Bacterial Infections, Bacterial Infections and Mycoses
Birmingham, Alabama, United States
View Trial DetailsNCT07205289
Bacterial Infections, Bacterial Infections and Mycoses
Adelaide, South Australia, Australia
View Trial Details