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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- Phase 3
Contacts et emplacements
Coordonnées de l'étude
- Nom: Pfizer CT.gov Call Center
- Numéro de téléphone: 1-800-718-1021
- E-mail: ClinicalTrials.gov_Inquiries@pfizer.com
Lieux d'étude
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Caguas, Porto Rico, 00725
- Recrutement
- Caguas Clinical Research LLC
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Ponce, Porto Rico, 00716
- Recrutement
- Ponce Medical School Foundation Inc. / CAIMED Center
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San Juan, Porto Rico, 00907-1509
- Recrutement
- BRCR Global Puerto Rico
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San Juan, Porto Rico, 00918
- Recrutement
- CMRC Headlands, LLC
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Alabama
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Birmingham, Alabama, États-Unis, 35233
- Recrutement
- UAB Child Health Research Unit (CHRU)
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Birmingham, Alabama, États-Unis, 35205
- Recrutement
- Alabama Clinical Therapeutics, LLC Birmingham Pediatric Associates
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Guntersville, Alabama, États-Unis, 35976
- Recrutement
- Lakeview Clinical Research, LLC
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California
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Fair Oaks, California, États-Unis, 95628
- Recrutement
- Apex Research Group
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Ontario, California, États-Unis, 91762
- Recrutement
- Orange County Research Institute
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Colorado
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Aurora, Colorado, États-Unis, 80045
- Recrutement
- Children's Hospital Colorado
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Florida
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Miami Lakes, Florida, États-Unis, 33016
- Recrutement
- Indago Research & Health Center, Inc
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Miami Lakes, Florida, États-Unis, 33014
- Recrutement
- Riveldi and Associates
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Tampa, Florida, États-Unis, 33617
- Pas encore de recrutement
- Children's Health Center
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Idaho
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Ammon, Idaho, États-Unis, 83406
- Recrutement
- Medical Research Partners
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Blackfoot, Idaho, États-Unis, 83221
- Recrutement
- Bingham Memorial Hospital
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Boise, Idaho, États-Unis, 83702
- Recrutement
- ASR, LLC
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Kentucky
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Bardstown, Kentucky, États-Unis, 40004
- Recrutement
- Kentucky Pediatric/ Adult Research
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Louisiana
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Covington, Louisiana, États-Unis, 70433
- Recrutement
- Avacare
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Lafayette, Louisiana, États-Unis, 70508
- Recrutement
- Velocity Clinical Research, Lafayette
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Shreveport, Louisiana, États-Unis, 71101
- Recrutement
- LSU Health Shreveport Clinical Trials Office
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Shreveport, Louisiana, États-Unis, 71101
- Recrutement
- Ochsner/LSU Health Shreveport - Progressive Pediatrics
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Shreveport, Louisiana, États-Unis, 71103
- Recrutement
- Ochsner LSU Health Shreveport Ambulatory Care Center
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Shreveport, Louisiana, États-Unis, 71103
- Recrutement
- Ochsner/LSU Health Shreveport Academic Medical Center
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Massachusetts
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Fall River, Massachusetts, États-Unis, 02721
- Recrutement
- Pediatric Associates of Fall River
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Michigan
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Bingham Farms, Michigan, États-Unis, 48025
- Recrutement
- Michigan Center of Medical Research
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Minnesota
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Minneapolis, Minnesota, États-Unis, 55402
- Recrutement
- Clinical Research Institute, Inc.
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Nebraska
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Lincoln, Nebraska, États-Unis, 68504
- Recrutement
- Midwest Children's Health Research Institute
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Lincoln, Nebraska, États-Unis, 68505
- Recrutement
- Midwest Children's Health Research Institute
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Lincoln, Nebraska, États-Unis, 68516
- Recrutement
- Midwest Children's Health Research Institute
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Lincoln, Nebraska, États-Unis, 68522
- Recrutement
- Midwest Children's Health Research Institute
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New York
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East Syracuse, New York, États-Unis, 13057
- Recrutement
- Child Health Care Associates
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Horseheads, New York, États-Unis, 14845
- Recrutement
- Corning Center for Clinical Research
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Rochester, New York, États-Unis, 14642
- Recrutement
- University of Rochester Medical Center
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Ohio
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Cincinnati, Ohio, États-Unis, 45245
- Recrutement
- Pediatric Associates of Mt. Carmel
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Cincinnati, Ohio, États-Unis, 45206
- Recrutement
- Cincinnati Children's Hospital Medical Center Investigational Drug Services
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Cincinnati, Ohio, États-Unis, 45206
- Recrutement
- Cincinnati Children's Hospital Medical Center Vaccine Research Center
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Dayton, Ohio, États-Unis, 45409
- Recrutement
- Dayton Clinical Research
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South Euclid, Ohio, États-Unis, 44121
- Recrutement
- Senders Pediatrics
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South Carolina
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Simpsonville, South Carolina, États-Unis, 29681
- Recrutement
- Tribe Clinical Research LLC. at Parkside Pediatrics Five Forks
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Tennessee
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Tullahoma, Tennessee, États-Unis, 37388
- Recrutement
- Pediatric Clinical Trials of Tennessee, LLC
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Texas
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Corpus Christi, Texas, États-Unis, 78411
- Recrutement
- Driscoll Children's Hosptial
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Houston, Texas, États-Unis, 77065
- Recrutement
- Kool Kids Pediatrics
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Houston, Texas, États-Unis, 77054
- Recrutement
- Mercury Clinical Research (Administrative Office)
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Houston, Texas, États-Unis, 77077
- Recrutement
- Mercury Clinical Research - Sunrise Pediatrics
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Houston, Texas, États-Unis, 77402
- Recrutement
- Neutra Life Sciences
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Houston, Texas, États-Unis, 77054
- Recrutement
- Mercury Clinical Research - Administrative Office
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Houston, Texas, États-Unis, 77074
- Pas encore de recrutement
- RTX Clinical Research
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Houston, Texas, États-Unis, 77087
- Recrutement
- Mercury Clinical Research - MD Kids Pediatrics
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League City, Texas, États-Unis, 77573
- Recrutement
- University of Texas Medical Branch,
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Lewisville, Texas, États-Unis, 75067
- Pas encore de recrutement
- Prime Clinical Research Inc.
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Mansfield, Texas, États-Unis, 76063
- Pas encore de recrutement
- Prime Clinical Research Inc.
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Richmond, Texas, États-Unis, 77469
- Recrutement
- Pediatric Center- Neutra Life Sciences
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San Antonio, Texas, États-Unis, 78215
- Recrutement
- Sun Research Institute
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Victoria, Texas, États-Unis, 77901
- Recrutement
- Victoria Clinical Research Group
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Utah
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Layton, Utah, États-Unis, 84041
- Recrutement
- Tanner Clinic
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Layton, Utah, États-Unis, 84041
- Recrutement
- Tanner Clinic - Layton Parkway
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Provo, Utah, États-Unis, 84604
- Recrutement
- AMR Clinical
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Syracuse, Utah, États-Unis, 84075
- Recrutement
- AMR Clinical
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West Jordan, Utah, États-Unis, 84088
- Recrutement
- Velocity Clinical Research, Salt Lake City
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Virginia
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Charlottesville, Virginia, États-Unis, 22902
- Recrutement
- Pediatric Research of Charlottesville, LLC
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Richmond, Virginia, États-Unis, 23226
- Recrutement
- Clinical Research Partners, LLC
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)
20-valent pneumococcal conjugate vaccine (20vPnC)
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Vaccin conjugué antipneumococcique 20-valent (20vPnC)
Autres noms:
|
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Expérimental: PG4 (intramuscular)
Multivalent Pneumococcal vaccine
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Multivalent Pneumococcal Vaccine
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Délai: Within 7 days after Vaccination
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Within 7 days after Vaccination
|
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Percentage of Participants With Systemic Events Within 7 Days after Vaccination
Délai: Within 7 days after Vaccination
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Within 7 days after Vaccination
|
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Percentage of Participants With Adverse Events (AEs)
Délai: From Vaccination to 1 month after Vaccination
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From Vaccination to 1 month after Vaccination
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Percentage of Participants With Serious Adverse Events (SAEs)
Délai: From Vaccination to 6 months after Vaccination
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From Vaccination to 6 months after Vaccination
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GMCs of serotype-specific IgG concentrations
Délai: 1 month after vaccination
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1 month after vaccination
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GMTs of serotype-specific OPA titers
Délai: 1 month after vaccination
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1 month after vaccination
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Percentage of participants with predefined serotype-specific IgG concentrations
Délai: 1 month after vaccination
|
1 month after vaccination
|
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IgG GMFRs
Délai: 1 month after vaccination
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1 month after vaccination
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Percentage of participants with a ≥4-fold rise in serotype-specific OPA titers
Délai: before to 1 month after vaccination
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before to 1 month after vaccination
|
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OPA GMFRs
Délai: before to 1 month after vaccination
|
before to 1 month after vaccination
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Pfizer CT.gov Call Center, Pfizer
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- C4931004
- 2025 (Subvention/contrat des NIH des États-Unis: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- 2025-523445-10-00 (Identificateur de registre: CTIS (EU))
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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produit fabriqué et exporté des États-Unis.
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