Tutkimus, jossa kerrotaan, kuinka uusi pneumokokkirokote toimii imeväisillä
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.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Vaihe 2
Yhteystiedot ja paikat
Opiskelupaikat
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San Juan, Puerto Rico, 00907-1509
- BRCR Global Puerto Rico
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San Juan, Puerto Rico, 00918
- CMRC Headlands, LLC
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PR
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Trujillo Alto, PR, Puerto Rico, 00976
- San Miguel Medical
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Puerto RICO
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Guayama, Puerto RICO, Puerto Rico, 00784
- Clinical Research Puerto Rico
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Ponce, Puerto RICO, Puerto Rico, 00716
- Ponce Medical School Foundation Inc.
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San Juan, Puerto RICO, Puerto Rico, 00935-6528
- University of Puerto Rico - Medical Sciences Campus
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San Juan, Puerto RICO, Puerto Rico, 00935
- The Hispanic Alliance for Clinical and Translational Research
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Arkansas
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Fayetteville, Arkansas, Yhdysvallat, 72703
- Northwest Arkansas Pediatric Clinic
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Jonesboro, Arkansas, Yhdysvallat, 72401
- The Children's Clinic
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California
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La Puente, California, Yhdysvallat, 91744
- Los Ninos Children's Medical Clinic
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West Covina, California, Yhdysvallat, 91790
- Los Ninos Children's Medical Clinic
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District of Columbia
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Washington D.C., District of Columbia, Yhdysvallat, 20016
- Velocity Clinical Research, Washington DC
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Florida
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Miami Lakes, Florida, Yhdysvallat, 33014
- Riveldi Biomedical Research and Associates - Miami
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Idaho
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Idaho Falls, Idaho, Yhdysvallat, 83404
- Clinical Research Prime
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Iowa
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Ankeny, Iowa, Yhdysvallat, 50023
- The Iowa Clinic
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Kansas
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Topeka, Kansas, Yhdysvallat, 66604
- Cotton O'Neil Pediatrics
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Kentucky
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Bardstown, Kentucky, Yhdysvallat, 40004
- Kentucky Pediatric/ Adult Research
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Louisville, Kentucky, Yhdysvallat, 40291
- Bluegrass Clinical Research, Inc.
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Louisville, Kentucky, Yhdysvallat, 40243
- All Children Pediatrics
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Louisiana
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Shreveport, Louisiana, Yhdysvallat, 71103
- Louisiana State University Health Sciences Shreveport
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Shreveport, Louisiana, Yhdysvallat, 71103
- Ochsner/LSU Health Ambulatory Care Center
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Shreveport, Louisiana, Yhdysvallat, 71101
- LSUHSC Clinical Trials Office
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Maryland
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Baltimore, Maryland, Yhdysvallat, 21201
- University of Maryland
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Frederick, Maryland, Yhdysvallat, 21702
- UMB/CVD
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Massachusetts
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Fall River, Massachusetts, Yhdysvallat, 02721
- Pediatric Associates of Fall River
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Montana
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Great Falls, Montana, Yhdysvallat, 59405
- Boeson Research GTF
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Great Falls, Montana, Yhdysvallat, 59405
- OBGYN Associates
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Great Falls, Montana, Yhdysvallat, 59405
- Origin Health
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Kalispell, Montana, Yhdysvallat, 59901
- Boeson Research KAL
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Kalispell, Montana, Yhdysvallat, 59901
- Heart and Hands Midwifery and Family Practice
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Kalispell, Montana, Yhdysvallat, 59901
- POEM Healthcare
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Missoula, Montana, Yhdysvallat, 59804
- Boeson Research MSO
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Missoula, Montana, Yhdysvallat, 59804
- Blue Moose Pediatrics
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Missoula, Montana, Yhdysvallat, 59804
- Boeson Research Laboratory
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Nebraska
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Lincoln, Nebraska, Yhdysvallat, 68522
- Midwest Children's Health Research Institute
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New York
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East Syracuse, New York, Yhdysvallat, 13057
- Child Health Care Associates
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Rochester, New York, Yhdysvallat, 14642
- University of Rochester Medical Center
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Rochester, New York, Yhdysvallat, 14611
- University of Rochester
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North Carolina
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Durham, North Carolina, Yhdysvallat, 27703
- Duke Vaccine and Trials Unit
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Durham, North Carolina, Yhdysvallat, 27704
- Durham Pediatrics at North Duke Street
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Durham, North Carolina, Yhdysvallat, 27701
- Velocity Clinical Research Inc.
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Ohio
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Dayton, Ohio, Yhdysvallat, 45409
- Dayton Clinical Research
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Dayton, Ohio, Yhdysvallat, 45414
- Ohio Pediatric Research Assn.
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South Euclid, Ohio, Yhdysvallat, 44121
- Senders Pediatrics
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Oregon
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Gresham, Oregon, Yhdysvallat, 97030
- Cyn3rgy Research
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Pennsylvania
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Erie, Pennsylvania, Yhdysvallat, 16506
- Allegheny Health and Wellness Pavilion
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Erie, Pennsylvania, Yhdysvallat, 16506
- Square-1 Clincal Research
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South Carolina
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Summerville, South Carolina, Yhdysvallat, 29486
- Coastal Pediatric Research
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Tennessee
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Kingsport, Tennessee, Yhdysvallat, 37660
- Holston Medical Group
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Texas
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Dallas, Texas, Yhdysvallat, 75287
- Oak Cliff Research Company, LLC
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Dallas, Texas, Yhdysvallat, 75230
- Javara Inc.
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Edinburg, Texas, Yhdysvallat, 78539
- PAS Research - McAllen
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Houston, Texas, Yhdysvallat, 77087
- Mercury Clinical Research - Pediatric Associates
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Houston, Texas, Yhdysvallat, 77054
- Mercury clinical research Inc.
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League City, Texas, Yhdysvallat, 77573
- University of Texas Medical Branch
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Longview, Texas, Yhdysvallat, 75605
- DCOL Center for Clinical Research
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Utah
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Kaysville, Utah, Yhdysvallat, 84037
- Tanner Clinic - Kaysville
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Kaysville, Utah, Yhdysvallat, 84037
- AMR Clinical
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Layton, Utah, Yhdysvallat, 84041
- Tanner Clinic
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Layton, Utah, Yhdysvallat, 84041
- Tanner Memorial Clinic
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Layton, Utah, Yhdysvallat, 84041
- Alliance for Multispecialty Research, LLC
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Murray, Utah, Yhdysvallat, 84107
- AMR Clinical
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Provo, Utah, Yhdysvallat, 84604
- AMR Clinical
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Roy, Utah, Yhdysvallat, 84067
- AMR Clinical
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South Jordan, Utah, Yhdysvallat, 84095
- AMR Clinical
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Syracuse, Utah, Yhdysvallat, 84075
- AMR Clinical
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Virginia
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Charlottesville, Virginia, Yhdysvallat, 22902
- Pediatric Research of Charlottesville, LLC
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Nelinkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: Group 1 PG4
Multivalent Pneumococcal Vaccine |
Multivalent pneumococcal conjugate vaccine |
|
Active Comparator: Group 1 20-valent pneumococcal conjugate vaccine (20vPnC)
20-valent pneumococcal conjugate vaccine (20vPnC) |
20-valent pneumococcal conjugate vaccine
Muut nimet:
|
|
Kokeellinen: Group 2 PG4
Multivalent Pneumococcal Vaccine |
Multivalent pneumococcal conjugate vaccine |
|
Active Comparator: Group 2 20-valent pneumococcal conjugate vaccine (20vPnC)
20-valent pneumococcal conjugate vaccine (20vPnC) |
20-valent pneumococcal conjugate vaccine
Muut nimet:
|
|
Kokeellinen: Group 3 PG4
Multivalent Pneumococcal Vaccine |
Multivalent pneumococcal conjugate vaccine |
|
Active Comparator: Group 3 20-valent pneumococcal conjugate vaccine (20vPnC)
20-valent pneumococcal conjugate vaccine (20vPnC) |
20-valent pneumococcal conjugate vaccine
Muut nimet:
|
|
Kokeellinen: Group 4 PG4
Multivalent Pneumococcal Vaccine |
Multivalent pneumococcal conjugate vaccine |
|
Active Comparator: Group 4 15-valent pneumococcal conjugate vaccine (PCV15)
15-valent pneumococcal conjugate vaccine (PCV15) |
15-valent pneumococcal conjugate vaccine
Muut nimet:
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Percentage of participants reporting local reactions within 7 days after each dose
Aikaikkuna: Day 7
|
Prompted local reactions after each dose |
Day 7
|
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Percentage of participants reporting systemic events within 7 days after each dose
Aikaikkuna: Day 7
|
Prompted systemic reactions after each dose |
Day 7
|
|
Percentage of participants reporting adverse events (AEs)
Aikaikkuna: Dose 1 to 1 month after Dose 3
|
AEs occurring from Dose 1 to 1 month after Dose 2 |
Dose 1 to 1 month after Dose 3
|
|
Percentage of participants reporting AEs
Aikaikkuna: Dose 4 to 1 month after Dose 4
|
AEs occurring from Dose 4 to 1 month after Dose 4 |
Dose 4 to 1 month after Dose 4
|
|
Percentage of participants reporting serious adverse events (SAEs)
Aikaikkuna: Dose 1 to 6 months after Dose 4
|
SAEs occurring from Dose 1 to 6 months after Dose 4 |
Dose 1 to 6 months after Dose 4
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Pneumococcal immunoglobulin G (IgG) geometric mean concentrations (GMCs)
Aikaikkuna: 1 month after Dose 4
|
Pneumococcal IgG GMCs 1 month after Dose 4 |
1 month after Dose 4
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Opintojohtaja: Pfizer CT.gov Call Center, Pfizer
Julkaisuja ja hyödyllisiä linkkejä
Hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- C4931002
- NCT06524414 (Rekisterin tunniste: ClinicalTrials.gov)
- 2025-000081-28 (EudraCT-numero)
- 2025 (Yhdysvaltain NIH-apuraha/sopimus)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
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.
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
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