Um estudo para aprender como funciona uma nova vacina pneumocócica em bebês
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.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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Arkansas
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Fayetteville, Arkansas, Estados Unidos, 72703
- Northwest Arkansas Pediatric Clinic
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Jonesboro, Arkansas, Estados Unidos, 72401
- The Children's Clinic
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California
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La Puente, California, Estados Unidos, 91744
- Los Ninos Children's Medical Clinic
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West Covina, California, Estados Unidos, 91790
- Los Ninos Children's Medical Clinic
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District of Columbia
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Washington D.C., District of Columbia, Estados Unidos, 20016
- Velocity Clinical Research, Washington DC
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Florida
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Miami Lakes, Florida, Estados Unidos, 33014
- Riveldi Biomedical Research and Associates - Miami
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Idaho
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Idaho Falls, Idaho, Estados Unidos, 83404
- Clinical Research Prime
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Iowa
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Ankeny, Iowa, Estados Unidos, 50023
- The Iowa Clinic
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Kansas
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Topeka, Kansas, Estados Unidos, 66604
- Cotton O'Neil Pediatrics
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Kentucky
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Bardstown, Kentucky, Estados Unidos, 40004
- Kentucky Pediatric/ Adult Research
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Louisville, Kentucky, Estados Unidos, 40291
- Bluegrass Clinical Research, Inc.
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Louisville, Kentucky, Estados Unidos, 40243
- All Children Pediatrics
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Louisiana
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Shreveport, Louisiana, Estados Unidos, 71103
- Louisiana State University Health Sciences Shreveport
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Shreveport, Louisiana, Estados Unidos, 71103
- Ochsner/LSU Health Ambulatory Care Center
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Shreveport, Louisiana, Estados Unidos, 71101
- LSUHSC Clinical Trials Office
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Maryland
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Baltimore, Maryland, Estados Unidos, 21201
- University of Maryland
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Frederick, Maryland, Estados Unidos, 21702
- UMB/CVD
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Massachusetts
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Fall River, Massachusetts, Estados Unidos, 02721
- Pediatric Associates of Fall River
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Montana
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Great Falls, Montana, Estados Unidos, 59405
- Boeson Research GTF
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Great Falls, Montana, Estados Unidos, 59405
- OBGYN Associates
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Great Falls, Montana, Estados Unidos, 59405
- Origin Health
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Kalispell, Montana, Estados Unidos, 59901
- Boeson Research KAL
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Kalispell, Montana, Estados Unidos, 59901
- Heart and Hands Midwifery and Family Practice
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Kalispell, Montana, Estados Unidos, 59901
- POEM Healthcare
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Missoula, Montana, Estados Unidos, 59804
- Boeson Research MSO
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Missoula, Montana, Estados Unidos, 59804
- Blue Moose Pediatrics
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Missoula, Montana, Estados Unidos, 59804
- Boeson Research Laboratory
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Nebraska
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Lincoln, Nebraska, Estados Unidos, 68522
- Midwest Children's Health Research Institute
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New York
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East Syracuse, New York, Estados Unidos, 13057
- Child Health Care Associates
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Rochester, New York, Estados Unidos, 14642
- University of Rochester Medical Center
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Rochester, New York, Estados Unidos, 14611
- University of Rochester
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North Carolina
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Durham, North Carolina, Estados Unidos, 27703
- Duke Vaccine and Trials Unit
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Durham, North Carolina, Estados Unidos, 27704
- Durham Pediatrics at North Duke Street
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Durham, North Carolina, Estados Unidos, 27701
- Velocity Clinical Research Inc.
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Ohio
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Dayton, Ohio, Estados Unidos, 45409
- Dayton Clinical Research
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Dayton, Ohio, Estados Unidos, 45414
- Ohio Pediatric Research Assn.
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South Euclid, Ohio, Estados Unidos, 44121
- Senders Pediatrics
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Oregon
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Gresham, Oregon, Estados Unidos, 97030
- Cyn3rgy Research
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Pennsylvania
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Erie, Pennsylvania, Estados Unidos, 16506
- Allegheny Health and Wellness Pavilion
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Erie, Pennsylvania, Estados Unidos, 16506
- Square-1 Clincal Research
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South Carolina
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Summerville, South Carolina, Estados Unidos, 29486
- Coastal Pediatric Research
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Tennessee
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Kingsport, Tennessee, Estados Unidos, 37660
- Holston Medical Group
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Texas
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Dallas, Texas, Estados Unidos, 75287
- Oak Cliff Research Company, LLC
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Dallas, Texas, Estados Unidos, 75230
- Javara Inc.
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Edinburg, Texas, Estados Unidos, 78539
- PAS Research - McAllen
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Houston, Texas, Estados Unidos, 77087
- Mercury Clinical Research - Pediatric Associates
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Houston, Texas, Estados Unidos, 77054
- Mercury clinical research Inc.
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League City, Texas, Estados Unidos, 77573
- University of Texas Medical Branch
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Longview, Texas, Estados Unidos, 75605
- DCOL Center for Clinical Research
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Utah
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Kaysville, Utah, Estados Unidos, 84037
- Tanner Clinic - Kaysville
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Kaysville, Utah, Estados Unidos, 84037
- AMR Clinical
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Layton, Utah, Estados Unidos, 84041
- Tanner Clinic
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Layton, Utah, Estados Unidos, 84041
- Tanner Memorial Clinic
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Layton, Utah, Estados Unidos, 84041
- Alliance for Multispecialty Research, LLC
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Murray, Utah, Estados Unidos, 84107
- AMR Clinical
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Provo, Utah, Estados Unidos, 84604
- AMR Clinical
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Roy, Utah, Estados Unidos, 84067
- AMR Clinical
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South Jordan, Utah, Estados Unidos, 84095
- AMR Clinical
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Syracuse, Utah, Estados Unidos, 84075
- AMR Clinical
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Virginia
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Charlottesville, Virginia, Estados Unidos, 22902
- Pediatric Research of Charlottesville, LLC
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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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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Group 1 PG4
Multivalent Pneumococcal Vaccine |
Multivalent pneumococcal conjugate vaccine |
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Comparador Ativo: Group 1 20-valent pneumococcal conjugate vaccine (20vPnC)
20-valent pneumococcal conjugate vaccine (20vPnC) |
20-valent pneumococcal conjugate vaccine
Outros nomes:
|
|
Experimental: Group 2 PG4
Multivalent Pneumococcal Vaccine |
Multivalent pneumococcal conjugate vaccine |
|
Comparador Ativo: Group 2 20-valent pneumococcal conjugate vaccine (20vPnC)
20-valent pneumococcal conjugate vaccine (20vPnC) |
20-valent pneumococcal conjugate vaccine
Outros nomes:
|
|
Experimental: Group 3 PG4
Multivalent Pneumococcal Vaccine |
Multivalent pneumococcal conjugate vaccine |
|
Comparador Ativo: Group 3 20-valent pneumococcal conjugate vaccine (20vPnC)
20-valent pneumococcal conjugate vaccine (20vPnC) |
20-valent pneumococcal conjugate vaccine
Outros nomes:
|
|
Experimental: Group 4 PG4
Multivalent Pneumococcal Vaccine |
Multivalent pneumococcal conjugate vaccine |
|
Comparador Ativo: Group 4 15-valent pneumococcal conjugate vaccine (PCV15)
15-valent pneumococcal conjugate vaccine (PCV15) |
15-valent pneumococcal conjugate vaccine
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Percentage of participants reporting local reactions within 7 days after each dose
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Pneumococcal immunoglobulin G (IgG) geometric mean concentrations (GMCs)
Prazo: 1 month after Dose 4
|
Pneumococcal IgG GMCs 1 month after Dose 4 |
1 month after Dose 4
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Pfizer CT.gov Call Center, Pfizer
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- C4931002
- NCT06524414 (Identificador de registro: ClinicalTrials.gov)
- 2025-000081-28 (Número EudraCT)
- 2025 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano 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.
Informações sobre medicamentos e dispositivos, documentos de estudo
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