Uno studio per conoscere come funziona un nuovo vaccino contro lo pneumococco nei neonati
A PHASE 2, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS
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 100 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.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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San Juan, Porto Rico, 00907-1509
- BRCR Global Puerto Rico
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San Juan, Porto Rico, 00918
- CMRC Headlands, LLC
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PR
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Trujillo Alto, PR, Porto Rico, 00976
- San Miguel Medical
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Puerto RICO
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Guayama, Puerto RICO, Porto Rico, 00784
- Clinical Research Puerto Rico
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Ponce, Puerto RICO, Porto Rico, 00716
- Ponce Medical School Foundation Inc.
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San Juan, Puerto RICO, Porto Rico, 00935-6528
- University of Puerto Rico - Medical Sciences Campus
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San Juan, Puerto RICO, Porto Rico, 00935
- The Hispanic Alliance for Clinical and Translational Research
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Arkansas
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Fayetteville, Arkansas, Stati Uniti, 72703
- Northwest Arkansas Pediatric Clinic
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Jonesboro, Arkansas, Stati Uniti, 72401
- The Children's Clinic
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California
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La Puente, California, Stati Uniti, 91744
- Los Ninos Children's Medical Clinic
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West Covina, California, Stati Uniti, 91790
- Los Ninos Children's Medical Clinic
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District of Columbia
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Washington D.C., District of Columbia, Stati Uniti, 20016
- Velocity Clinical Research, Washington DC
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Florida
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Miami Lakes, Florida, Stati Uniti, 33014
- Riveldi Biomedical Research and Associates - Miami
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Idaho
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Idaho Falls, Idaho, Stati Uniti, 83404
- Clinical Research Prime
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Iowa
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Ankeny, Iowa, Stati Uniti, 50023
- The Iowa Clinic
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Kansas
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Topeka, Kansas, Stati Uniti, 66604
- Cotton O'Neil Pediatrics
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Kentucky
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Bardstown, Kentucky, Stati Uniti, 40004
- Kentucky Pediatric/ Adult Research
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Louisville, Kentucky, Stati Uniti, 40291
- Bluegrass Clinical Research, Inc.
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Louisville, Kentucky, Stati Uniti, 40243
- All Children Pediatrics
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Louisiana
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Shreveport, Louisiana, Stati Uniti, 71103
- Louisiana State University Health Sciences Shreveport
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Shreveport, Louisiana, Stati Uniti, 71103
- Ochsner/LSU Health Ambulatory Care Center
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Shreveport, Louisiana, Stati Uniti, 71101
- LSUHSC Clinical Trials Office
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Maryland
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Baltimore, Maryland, Stati Uniti, 21201
- University of Maryland
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Frederick, Maryland, Stati Uniti, 21702
- UMB/CVD
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Massachusetts
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Fall River, Massachusetts, Stati Uniti, 02721
- Pediatric Associates of Fall River
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Montana
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Great Falls, Montana, Stati Uniti, 59405
- Boeson Research GTF
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Great Falls, Montana, Stati Uniti, 59405
- OBGYN Associates
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Great Falls, Montana, Stati Uniti, 59405
- Origin Health
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Kalispell, Montana, Stati Uniti, 59901
- Boeson Research KAL
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Kalispell, Montana, Stati Uniti, 59901
- Heart and Hands Midwifery and Family Practice
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Kalispell, Montana, Stati Uniti, 59901
- POEM Healthcare
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Missoula, Montana, Stati Uniti, 59804
- Boeson Research MSO
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Missoula, Montana, Stati Uniti, 59804
- Blue Moose Pediatrics
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Missoula, Montana, Stati Uniti, 59804
- Boeson Research Laboratory
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Nebraska
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Lincoln, Nebraska, Stati Uniti, 68522
- Midwest Children's Health Research Institute
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New York
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East Syracuse, New York, Stati Uniti, 13057
- Child Health Care Associates
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Rochester, New York, Stati Uniti, 14642
- University of Rochester Medical Center
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Rochester, New York, Stati Uniti, 14611
- University of Rochester
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North Carolina
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Durham, North Carolina, Stati Uniti, 27703
- Duke Vaccine and Trials Unit
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Durham, North Carolina, Stati Uniti, 27704
- Durham Pediatrics at North Duke Street
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Durham, North Carolina, Stati Uniti, 27701
- Velocity Clinical Research Inc.
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Ohio
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Dayton, Ohio, Stati Uniti, 45409
- Dayton Clinical Research
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Dayton, Ohio, Stati Uniti, 45414
- Ohio Pediatric Research Assn.
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South Euclid, Ohio, Stati Uniti, 44121
- Senders Pediatrics
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Oregon
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Gresham, Oregon, Stati Uniti, 97030
- Cyn3rgy Research
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Pennsylvania
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Erie, Pennsylvania, Stati Uniti, 16506
- Allegheny Health and Wellness Pavilion
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Erie, Pennsylvania, Stati Uniti, 16506
- Square-1 Clincal Research
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South Carolina
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Summerville, South Carolina, Stati Uniti, 29486
- Coastal Pediatric Research
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Tennessee
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Kingsport, Tennessee, Stati Uniti, 37660
- Holston Medical Group
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Texas
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Dallas, Texas, Stati Uniti, 75287
- Oak Cliff Research Company, LLC
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Dallas, Texas, Stati Uniti, 75230
- Javara Inc.
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Edinburg, Texas, Stati Uniti, 78539
- PAS Research - McAllen
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Houston, Texas, Stati Uniti, 77087
- Mercury Clinical Research - Pediatric Associates
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Houston, Texas, Stati Uniti, 77054
- Mercury clinical research Inc.
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League City, Texas, Stati Uniti, 77573
- University of Texas Medical Branch
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Longview, Texas, Stati Uniti, 75605
- DCOL Center for Clinical Research
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Utah
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Kaysville, Utah, Stati Uniti, 84037
- Tanner Clinic - Kaysville
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Kaysville, Utah, Stati Uniti, 84037
- AMR Clinical
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Layton, Utah, Stati Uniti, 84041
- Tanner Clinic
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Layton, Utah, Stati Uniti, 84041
- Tanner Memorial Clinic
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Layton, Utah, Stati Uniti, 84041
- Alliance for Multispecialty Research, LLC
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Murray, Utah, Stati Uniti, 84107
- AMR Clinical
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Provo, Utah, Stati Uniti, 84604
- AMR Clinical
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Roy, Utah, Stati Uniti, 84067
- AMR Clinical
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South Jordan, Utah, Stati Uniti, 84095
- AMR Clinical
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Syracuse, Utah, Stati Uniti, 84075
- AMR Clinical
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Virginia
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Charlottesville, Virginia, Stati Uniti, 22902
- Pediatric Research of Charlottesville, LLC
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Group 1 PG4
Multivalent Pneumococcal Vaccine |
Multivalent pneumococcal conjugate vaccine |
|
Comparatore attivo: Group 1 20-valent pneumococcal conjugate vaccine (20vPnC)
20-valent pneumococcal conjugate vaccine (20vPnC) |
20-valent pneumococcal conjugate vaccine
Altri nomi:
|
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Sperimentale: Group 2 PG4
Multivalent Pneumococcal Vaccine |
Multivalent pneumococcal conjugate vaccine |
|
Comparatore attivo: Group 2 20-valent pneumococcal conjugate vaccine (20vPnC)
20-valent pneumococcal conjugate vaccine (20vPnC) |
20-valent pneumococcal conjugate vaccine
Altri nomi:
|
|
Sperimentale: Group 3 PG4
Multivalent Pneumococcal Vaccine |
Multivalent pneumococcal conjugate vaccine |
|
Comparatore attivo: Group 3 20-valent pneumococcal conjugate vaccine (20vPnC)
20-valent pneumococcal conjugate vaccine (20vPnC) |
20-valent pneumococcal conjugate vaccine
Altri nomi:
|
|
Sperimentale: Group 4 PG4
Multivalent Pneumococcal Vaccine |
Multivalent pneumococcal conjugate vaccine |
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Comparatore attivo: Group 4 15-valent pneumococcal conjugate vaccine (PCV15)
15-valent pneumococcal conjugate vaccine (PCV15) |
15-valent pneumococcal conjugate vaccine
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Percentage of participants reporting local reactions within 7 days after each dose
Lasso di tempo: Day 7
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Prompted local reactions after each dose |
Day 7
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Percentage of participants reporting systemic events within 7 days after each dose
Lasso di tempo: Day 7
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Prompted systemic reactions after each dose |
Day 7
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Percentage of participants reporting adverse events (AEs)
Lasso di tempo: Dose 1 to 1 month after Dose 3
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AEs occurring from Dose 1 to 1 month after Dose 2 |
Dose 1 to 1 month after Dose 3
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Percentage of participants reporting AEs
Lasso di tempo: Dose 4 to 1 month after Dose 4
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AEs occurring from Dose 4 to 1 month after Dose 4 |
Dose 4 to 1 month after Dose 4
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Percentage of participants reporting serious adverse events (SAEs)
Lasso di tempo: Dose 1 to 6 months after Dose 4
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SAEs occurring from Dose 1 to 6 months after Dose 4 |
Dose 1 to 6 months after Dose 4
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Pneumococcal immunoglobulin G (IgG) geometric mean concentrations (GMCs)
Lasso di tempo: 1 month after Dose 4
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Pneumococcal IgG GMCs 1 month after Dose 4 |
1 month after Dose 4
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Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Pfizer CT.gov Call Center, Pfizer
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- C4931002
- NCT06524414 (Identificatore di registro: ClinicalTrials.gov)
- 2025-000081-28 (Numero EudraCT)
- 2025 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Informazioni su farmaci e dispositivi, documenti di studio
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Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .