Study to Learn About Safety, Tolerability, and Immune Response of a Catch-up Pneumococcal Vaccine in Children and Adolescents
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
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 3
Kontakter och platser
Studiekontakt
- Namn: Pfizer CT.gov Call Center
- Telefonnummer: 1-800-718-1021
- E-post: ClinicalTrials.gov_Inquiries@pfizer.com
Studieorter
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Alabama
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Birmingham, Alabama, Förenta staterna, 35233
- Rekrytering
- UAB Child Health Research Unit (CHRU)
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Birmingham, Alabama, Förenta staterna, 35205
- Rekrytering
- Alabama Clinical Therapeutics, LLC Birmingham Pediatric Associates
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Guntersville, Alabama, Förenta staterna, 35976
- Rekrytering
- Lakeview Clinical Research, LLC
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California
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Fair Oaks, California, Förenta staterna, 95628
- Rekrytering
- Apex Research Group
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Ontario, California, Förenta staterna, 91762
- Rekrytering
- Orange County Research Institute
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Colorado
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Aurora, Colorado, Förenta staterna, 80045
- Rekrytering
- Children's Hospital Colorado
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Florida
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Miami Lakes, Florida, Förenta staterna, 33016
- Rekrytering
- Indago Research & Health Center, Inc
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Miami Lakes, Florida, Förenta staterna, 33014
- Rekrytering
- Riveldi and Associates
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Tampa, Florida, Förenta staterna, 33617
- Har inte rekryterat ännu
- Children's Health Center
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Idaho
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Ammon, Idaho, Förenta staterna, 83406
- Rekrytering
- Medical Research Partners
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Blackfoot, Idaho, Förenta staterna, 83221
- Rekrytering
- Bingham Memorial Hospital
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Boise, Idaho, Förenta staterna, 83702
- Rekrytering
- ASR, LLC
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Kentucky
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Bardstown, Kentucky, Förenta staterna, 40004
- Rekrytering
- Kentucky Pediatric/ Adult Research
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Louisiana
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Covington, Louisiana, Förenta staterna, 70433
- Rekrytering
- Avacare
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Lafayette, Louisiana, Förenta staterna, 70508
- Rekrytering
- Velocity Clinical Research, Lafayette
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Shreveport, Louisiana, Förenta staterna, 71101
- Rekrytering
- LSU Health Shreveport Clinical Trials Office
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Shreveport, Louisiana, Förenta staterna, 71101
- Rekrytering
- Ochsner/LSU Health Shreveport - Progressive Pediatrics
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Shreveport, Louisiana, Förenta staterna, 71103
- Rekrytering
- Ochsner LSU Health Shreveport Ambulatory Care Center
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Shreveport, Louisiana, Förenta staterna, 71103
- Rekrytering
- Ochsner/LSU Health Shreveport Academic Medical Center
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Massachusetts
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Fall River, Massachusetts, Förenta staterna, 02721
- Rekrytering
- Pediatric Associates of Fall River
-
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Michigan
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Bingham Farms, Michigan, Förenta staterna, 48025
- Rekrytering
- Michigan Center of Medical Research
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Minnesota
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Minneapolis, Minnesota, Förenta staterna, 55402
- Rekrytering
- Clinical Research Institute, Inc.
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Nebraska
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Lincoln, Nebraska, Förenta staterna, 68504
- Rekrytering
- Midwest Children's Health Research Institute
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Lincoln, Nebraska, Förenta staterna, 68505
- Rekrytering
- Midwest Children's Health Research Institute
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Lincoln, Nebraska, Förenta staterna, 68516
- Rekrytering
- Midwest Children's Health Research Institute
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Lincoln, Nebraska, Förenta staterna, 68522
- Rekrytering
- Midwest Children's Health Research Institute
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New York
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East Syracuse, New York, Förenta staterna, 13057
- Rekrytering
- Child Health Care Associates
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Horseheads, New York, Förenta staterna, 14845
- Rekrytering
- Corning Center for Clinical Research
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Rochester, New York, Förenta staterna, 14642
- Rekrytering
- University of Rochester Medical Center
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Ohio
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Cincinnati, Ohio, Förenta staterna, 45245
- Rekrytering
- Pediatric Associates of Mt. Carmel
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Cincinnati, Ohio, Förenta staterna, 45206
- Rekrytering
- Cincinnati Children's Hospital Medical Center Investigational Drug Services
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Cincinnati, Ohio, Förenta staterna, 45206
- Rekrytering
- Cincinnati Children's Hospital Medical Center Vaccine Research Center
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Dayton, Ohio, Förenta staterna, 45409
- Rekrytering
- Dayton Clinical Research
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South Euclid, Ohio, Förenta staterna, 44121
- Rekrytering
- Senders Pediatrics
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South Carolina
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Simpsonville, South Carolina, Förenta staterna, 29681
- Rekrytering
- Tribe Clinical Research LLC. at Parkside Pediatrics Five Forks
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Tennessee
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Tullahoma, Tennessee, Förenta staterna, 37388
- Rekrytering
- Pediatric Clinical Trials of Tennessee, LLC
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Texas
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Corpus Christi, Texas, Förenta staterna, 78411
- Rekrytering
- Driscoll Children's Hosptial
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Houston, Texas, Förenta staterna, 77065
- Rekrytering
- Kool Kids Pediatrics
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Houston, Texas, Förenta staterna, 77054
- Rekrytering
- Mercury Clinical Research (Administrative Office)
-
Houston, Texas, Förenta staterna, 77077
- Rekrytering
- Mercury Clinical Research - Sunrise Pediatrics
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Houston, Texas, Förenta staterna, 77402
- Rekrytering
- Neutra Life Sciences
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Houston, Texas, Förenta staterna, 77054
- Rekrytering
- Mercury Clinical Research - Administrative Office
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Houston, Texas, Förenta staterna, 77074
- Har inte rekryterat ännu
- RTX Clinical Research
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Houston, Texas, Förenta staterna, 77087
- Rekrytering
- Mercury Clinical Research - MD Kids Pediatrics
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League City, Texas, Förenta staterna, 77573
- Rekrytering
- University of Texas Medical Branch,
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Lewisville, Texas, Förenta staterna, 75067
- Har inte rekryterat ännu
- Prime Clinical Research Inc.
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Mansfield, Texas, Förenta staterna, 76063
- Har inte rekryterat ännu
- Prime Clinical Research Inc.
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Richmond, Texas, Förenta staterna, 77469
- Rekrytering
- Pediatric Center- Neutra Life Sciences
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San Antonio, Texas, Förenta staterna, 78215
- Rekrytering
- Sun Research Institute
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Victoria, Texas, Förenta staterna, 77901
- Rekrytering
- Victoria Clinical Research Group
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Utah
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Layton, Utah, Förenta staterna, 84041
- Rekrytering
- Tanner Clinic
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Layton, Utah, Förenta staterna, 84041
- Rekrytering
- Tanner Clinic - Layton Parkway
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Provo, Utah, Förenta staterna, 84604
- Rekrytering
- AMR Clinical
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Syracuse, Utah, Förenta staterna, 84075
- Rekrytering
- AMR Clinical
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West Jordan, Utah, Förenta staterna, 84088
- Rekrytering
- Velocity Clinical Research, Salt Lake City
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Virginia
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Charlottesville, Virginia, Förenta staterna, 22902
- Rekrytering
- Pediatric Research of Charlottesville, LLC
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Richmond, Virginia, Förenta staterna, 23226
- Rekrytering
- Clinical Research Partners, LLC
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Caguas, Puerto Rico, 00725
- Rekrytering
- Caguas Clinical Research LLC
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Ponce, Puerto Rico, 00716
- Rekrytering
- Ponce Medical School Foundation Inc. / CAIMED Center
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San Juan, Puerto Rico, 00907-1509
- Rekrytering
- BRCR Global Puerto Rico
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San Juan, Puerto Rico, 00918
- Rekrytering
- CMRC Headlands, LLC
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)
20-valent pneumococcal conjugate vaccine (20vPnC)
|
20-valent pneumokockkonjugatvaccin (20vPnC)
Andra namn:
|
|
Experimentell: PG4 (intramuscular)
Multivalent Pneumococcal vaccine
|
Multivalent Pneumococcal Vaccine
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Tidsram: Within 7 days after Vaccination
|
Within 7 days after Vaccination
|
|
Percentage of Participants With Systemic Events Within 7 Days after Vaccination
Tidsram: Within 7 days after Vaccination
|
Within 7 days after Vaccination
|
|
Percentage of Participants With Adverse Events (AEs)
Tidsram: From Vaccination to 1 month after Vaccination
|
From Vaccination to 1 month after Vaccination
|
|
Percentage of Participants With Serious Adverse Events (SAEs)
Tidsram: From Vaccination to 6 months after Vaccination
|
From Vaccination to 6 months after Vaccination
|
|
GMCs of serotype-specific IgG concentrations
Tidsram: 1 month after vaccination
|
1 month after vaccination
|
|
GMTs of serotype-specific OPA titers
Tidsram: 1 month after vaccination
|
1 month after vaccination
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Percentage of participants with predefined serotype-specific IgG concentrations
Tidsram: 1 month after vaccination
|
1 month after vaccination
|
|
IgG GMFRs
Tidsram: 1 month after vaccination
|
1 month after vaccination
|
|
Percentage of participants with a ≥4-fold rise in serotype-specific OPA titers
Tidsram: before to 1 month after vaccination
|
before to 1 month after vaccination
|
|
OPA GMFRs
Tidsram: before to 1 month after vaccination
|
before to 1 month after vaccination
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Pfizer CT.gov Call Center, Pfizer
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- C4931004
- 2025 (U.S.S. NIH-anslag/kontrakt: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- 2025-523445-10-00 (Registeridentifierare: CTIS (EU))
Plan för individuella deltagardata (IPD)
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IPD-planbeskrivning
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