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Estudo de coadministração de uma vacina experimental contra o vírus sincicial respiratório vivo atenuado em bebês e crianças pequenas (CORAL)

15 de setembro de 2026 atualizado por: Sanofi Pasteur, a Sanofi Company

Estudo de fase III, randomizado, simples-cego, controlado por placebo e multicêntrico para avaliar a não interferência da administração concomitante de vacinas pediátricas de rotina na resposta de anticorpos de uma vacina experimental de vírus sincicial respiratório vivo atenuado (RSV) em bebês saudáveis ​​e Crianças (CORAL)

This study is a Phase III, randomized, single-blind, placebo-controlled, multi-center study to be conducted in healthy infants and toddlers which will be enrolled at approximately 6 months of age (Cohort 1) and approximately 12 months of age (Cohort 2). The primary objective of the study will be to assess non-inferiority of the RSV infant and toddler (RSVt) vaccine antibody response when administered concomitantly with routine pediatric vaccines at 6 months of age (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine [Vaxelis® or Pentacel® and Recombivax HB®] Prevnar 20®, and RotaTeq®), and 12 months of age (M-M-R II, VARIVAX, and Prevnar 20 or per local country recommendations) compared to when administered non-concomitantly.

Visão geral do estudo

Status

Rescindido

Condições

Intervenção / Tratamento

Descrição detalhada

The study duration is approximately 9 months for each participant.

  • Cohort 1: Visits at 6, 7, and 8 and 9 months of age for both groups with visit at 10 months of age for Group 2 only
  • Cohort 2: Visits at 12, 13, 14 and 15 months of age for both groups with visit at 16 months of age for Group 4 only
  • Routine pediatric vaccines (authorized auxiliary medicinal products (AxMP) will be administered at 6 months in Cohort 1 and 12 months of age in Cohort 2, as per Advisory Committee on Immunization Practice (ACIP) or local country recommendations.

Tipo de estudo

Intervencional

Inscrição (Real)

2226

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35205
        • Alabama Clinical Therapeutics - Birmingham - St. Vincent's Drive- Site Number : 8400007
      • Grand Bay, Alabama, Estados Unidos, 36541
        • South Alabama Medical Clinic- Site Number : 8400065
      • Mobile, Alabama, Estados Unidos, 36608
        • MedPharmics - Mobile - Dauphin Street- Site Number : 8400017
    • Arkansas
      • Fayetteville, Arkansas, Estados Unidos, 72703
        • Northwest Arkansas Pediatric Clinic- Site Number : 8400002
    • California
      • Bell Gardens, California, Estados Unidos, 90201
        • Alliance Research Institute - Bell Gardens - Garfield Avenue- Site Number : 8400040
      • Huntington Park, California, Estados Unidos, 90255
        • Matrix Clinical Research - Huntington Park- Site Number : 8400018
      • La Mesa, California, Estados Unidos, 91942
        • Paradigm Clinical Research Centers- Site Number : 8400059
      • Los Angeles, California, Estados Unidos, 90057
        • Matrix Clinical Research - Los Angeles- Site Number : 8400008
      • Oakland, California, Estados Unidos, 94611
        • Kaiser Permanente - Oakland Medical Center- Site Number : 8400047
      • Palo Alto, California, Estados Unidos, 94304
        • Stanford University Medical Center CTRU - 800 Welch Road- Site Number : 8400070
      • Roseville, California, Estados Unidos, 95661
        • Kaiser Permanente - Sierra Gardens- Site Number : 8400063
      • Sacramento, California, Estados Unidos, 95815
        • Kaiser Permanente - Point West Medical Offices- Site Number : 8400064
      • San Jose, California, Estados Unidos, 95119
        • Kaiser Permanente - San Jose Medical Center- Site Number : 8400060
      • Santa Clara, California, Estados Unidos, 95051
        • Kaiser Permanente - Santa Clara Medical Center- Site Number : 8400061
      • Sherman Oaks, California, Estados Unidos, 91356-4173
        • Integrated Clinical Research LLC- Site Number : 8400036
      • Walnut Creek, California, Estados Unidos, 94596
        • Kaiser Permanente - Walnut Creek Medical Center- Site Number : 8400062
    • District of Columbia
      • Washington D.C., District of Columbia, Estados Unidos, 20016
        • Velocity Clinical Research - Washington DC- Site Number : 8400050
    • Florida
      • Doral, Florida, Estados Unidos, 33166
        • Prohealth Research Center- Site Number : 8400068
      • Hollywood, Florida, Estados Unidos, 33021
        • The Medici Medical Research- Site Number : 8400055
      • Miami, Florida, Estados Unidos, 33126
        • Dade Research Center- Site Number : 8400014
      • Miami Lakes, Florida, Estados Unidos, 33014
        • Riveldi Biomedical Research and Associates - Miami Lakes- Site Number : 8400015
      • Pensacola, Florida, Estados Unidos, 32501
        • SEC Clinical Research - Pensacola- Site Number : 8400034
      • Tampa, Florida, Estados Unidos, 33613
        • PAS Research- Site Number : 8400005
    • Idaho
      • Idaho Falls, Idaho, Estados Unidos, 83404
        • Leavitt Women's Healthcare- Site Number : 8400009
    • Iowa
      • Sioux City, Iowa, Estados Unidos, 51106
        • Velocity Clinical Research - Sioux City- Site Number : 8400054
    • Kansas
      • El Dorado, Kansas, Estados Unidos, 67042
        • Alliance for Multispeciality Research - El Dorado- Site Number : 8400019
    • Kentucky
      • Lexington, Kentucky, Estados Unidos, 40536
        • University of Kentucky Chandler Medical Center- Site Number : 8400051
    • Louisiana
      • New Orleans, Louisiana, Estados Unidos, 70119
        • Velocity Clinical Research - New Orleans- Site Number : 8400058
      • New Orleans, Louisiana, Estados Unidos, 70125
        • Research Works INC- Site Number : 8400044
    • Mississippi
      • Gulfport, Mississippi, Estados Unidos, 39503
        • Velocity Clinical Research - Gulfport- Site Number : 8400011
    • Missouri
      • Springfield, Missouri, Estados Unidos, 65802
        • QPS Bio-Kinetic Clinical Applications- Site Number : 8400046
    • Montana
      • Great Falls, Montana, Estados Unidos, 59405
        • Boeson Research - Great Falls- Site Number : 8400041
      • Missoula, Montana, Estados Unidos, 59804
        • Boeson Research - Missoula- Site Number : 8400006
    • Nebraska
      • Grand Island, Nebraska, Estados Unidos, 68803
        • Velocity Clinical Research - Grand Island- Site Number : 8400016
      • Lincoln, Nebraska, Estados Unidos, 68516
        • Midwest Childrens Health Research Institute- Site Number : 8400038
      • Omaha, Nebraska, Estados Unidos, 68134
        • Velocity Clinical Research - Omaha- Site Number : 8400001
    • Nevada
      • Henderson, Nevada, Estados Unidos, 89014
        • PAS Research - Henderson- Site Number : 8400049
    • New York
      • Garden City, New York, Estados Unidos, 11530
        • NYU Langone Cardiothoracic Surgery Associates - Garden City- Site Number : 8400048
      • Liverpool, New York, Estados Unidos, 13088
        • Summerwood Pediatrics- Site Number : 8400021
      • Syracuse, New York, Estados Unidos, 13210
        • SUNY Upstate Medical University - Syracuse- Site Number : 8400029
    • Ohio
      • Dayton, Ohio, Estados Unidos, 45414
        • Ohio Pediatrics - Dayton- Site Number : 8400033
      • Dayton, Ohio, Estados Unidos, 45409
        • Dayton Clinical Research- Site Number : 8400030
      • South Euclid, Ohio, Estados Unidos, 44121
        • Senders Pediatrics- Site Number : 8400022
    • Oregon
      • Gresham, Oregon, Estados Unidos, 97030
        • Cyn3rgy Research- Site Number : 8400053
    • Pennsylvania
      • Erie, Pennsylvania, Estados Unidos, 16506
        • Square-1 Clinical Research- Site Number : 8400031
      • Pittsburgh, Pennsylvania, Estados Unidos, 15227
        • Pas Research - Pittsburgh- Site Number : 8400043
    • South Carolina
      • Charleston, South Carolina, Estados Unidos, 29407
        • Neighbors Pediatrics- Site Number : 8400072
      • Greenville, South Carolina, Estados Unidos, 29607
        • Tribe Clinical Research - Greenville - Verdae Boulevard- Site Number : 8400012
    • Texas
      • Corpus Christi, Texas, Estados Unidos, 78413
        • South Texas Clinical Research- Site Number : 8400004
      • Dallas, Texas, Estados Unidos, 75230
        • Javara - Privia Medical Group North Texas - Dallas- Site Number : 8400003
      • Edinburg, Texas, Estados Unidos, 78539
        • PAS Research - Children's Care Clinic- Site Number : 8400035
      • Fort Worth, Texas, Estados Unidos, 76104
        • Helios Clinical Research - Fort Worth - 8th Avenue- Site Number : 8400020
      • Houston, Texas, Estados Unidos, 77008
        • Ventavia Research Group - Houston - North Loop West- Site Number : 8400010
      • Houston, Texas, Estados Unidos, 77065
        • DM Clinical Research - Houston - Jones Road- Site Number : 8400052
      • Houston, Texas, Estados Unidos, 77070
        • Mercury Clinical Research - Houston - Savoy Drive- Site Number : 8400045
      • Houston, Texas, Estados Unidos, 77090
        • Houston Clinical Research Associates- Site Number : 8400013
      • Houston, Texas, Estados Unidos, 77030
        • The University of Texas Health Science Center- Site Number : 8400037
      • Houston, Texas, Estados Unidos, 77071
        • La Providence Pediatrics & Family Clinics- Site Number : 8400039
      • League City, Texas, Estados Unidos, 77555
        • University of Texas Medical Branch at Galveston- Site Number : 8400057
      • League City, Texas, Estados Unidos, 77573
        • Maximos Ob/Gyn- Site Number : 8400024
      • Plano, Texas, Estados Unidos, 75093
        • Research Your Health- Site Number : 8400066
      • Richmond, Texas, Estados Unidos, 77469
        • Pediatric Center - Richmond- Site Number : 8400032
      • Tomball, Texas, Estados Unidos, 77375
        • North Houston Internal Medicine & Pediatric Clinic- Site Number : 8400025
    • Utah
      • Orem, Utah, Estados Unidos, 84057
        • Utah Valley Pediatrics - Orem- Site Number : 8400067
      • Pleasant View, Utah, Estados Unidos, 84404
        • Ogden Clinic - Mountain View - CCT Research- Site Number : 8400056
      • Roy, Utah, Estados Unidos, 84067
        • Wee Care Pediatrics - Roy- Site Number : 8400071
  • México
      • Mexico City, México, 06760
        • Investigational Site Number : 4840004
    • Mexico City
      • Mexico City, Mexico City, México, 04530
        • Investigational Site Number : 4840001
    • Morelos
      • Temixco, Morelos, México, 62587
        • Investigational Site Number : 4840002
  • Porto Rico
      • Caguas, Porto Rico, 00725
        • Investigational Site Number : 6300001
      • Ponce, Porto Rico, 00716
        • Investigational Site Number : 6300003
      • Trujillo Alto, Porto Rico, 00976
        • Investigational Site Number : 6300004

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

6 meses a 1 ano (Filho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Aged 6 months for Cohort 1 and 12 months for Cohort 2 on the day of inclusion ("6 months" means from the day of the 6-month birthday to the day before the 7-month birthday and "12 months" means from the day of the 12-month birthday to the day before the 13-month birthday)
  • Participants who are healthy as determined by medical evaluation including medical history and physical examination
  • For Cohort 1: Infant received doses of vaccines containing hepatitis B, diphtheria, tetanus, pertussis, Haemophilus influenzae type B (Hib), and inactivated poliovirus vaccine (IPV) antigens, with Advisory Committee on Immunization Practice (ACIP) recommended vaccines. The last dose(s) of these vaccines must be at least 28 days before the first study visit
  • Infant received the recommended doses of a recommended pneumococcal conjugate vaccine (as per local schedule) at least 28 days before the first study visit.

Exclusion Criteria:

  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
  • Known previous infection with diphtheria, tetanus, Hib, measles, mumps, rubella, rotavirus, pneumococcus, polio, hepatitis B virus
  • Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study intervention used in the study or to a product containing any of the same substances
  • Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
  • History of medically diagnosed wheezing
  • Any acute febrile illness in the past 48 hours that according to investigator judgment is significant enough to interfere with successful inoculation on the day of vaccination. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
  • Probable or confirmed ongoing case of viral respiratory infection (including COVID 19, influenza, rhinovirus, etc.) at the time of enrollment. A prospective participant should not be included in the study until the respiratory infection has resolved.
  • Member of a household that contains an immunocompromised individual, including, but not limited to:
  • A person living with human immunodeficiency virus (HIV)
  • A person who has received chemotherapy within the 12 months prior to study enrollment
  • A person who has received (within the past 6 months) or is receiving (at the time of enrollment) immunosuppressant agents
  • A person living with a solid organ or bone marrow transplant
  • Potential close contact with other immunocompromised individual within 30 days after each vaccination as per investigator's discretion
  • History of definitive contraindications to any of the concomitant vaccines that will be administered as part of the study protocol
  • Participant's biological mother with previous receipt or planned administration of an investigational RSV vaccine during pregnancy and/or breastfeeding
  • Receipt of any vaccine in the 4 weeks preceding RSVt vaccine administration or planned receipt of any vaccine outside of study protocol in the 4 weeks following RSVt vaccine administration, except for influenza and/or COVID-19 vaccination, which may be received at least 1 week before or 1 week after RSVt vaccine administration
  • Previous receipt of an investigational RSV vaccine or receiving any anti RSV product (such as ribavirin or RSV immune globulin) at the time of enrollment
  • Receipt of immune globulins, blood or blood-derived products in the past 3 months
  • Receipt of intranasal and intra-ocular medications within 3 days prior to study enrollment
  • Previous receipt of an RSV monoclonal antibody within 6 months prior to the first study vaccine administration or planned receipt for duration of the study
  • For Cohort 1: Prior receipt of routine 6-month pediatric vaccine doses (as per local schedule)
  • For Cohort 2: Prior receipt of routine 12-month pediatric vaccine doses (as per local schedule)
  • Participation at the time of study enrollment (or in the 6 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure

Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Triplo

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Cohort 1: Group 1- (RSVt vaccine concomitantly at 6 months)

Participants will be administered RSVt vaccine concomitantly with routine pediatric vaccines, 2 doses, at age 6 months. Vaccines administered at age 6 months: RSVt Vaxelis or Pentacel and Recombivax HB, Prevnar 20, and RotaTeq. Placebo will be administered non-concomitantly at 7 months of age
Biológico: RSVt vaccine

Pharmaceutical form:Liquid for nasal spray-Route of administration:Intranasal

Outros nomes:
  • 534
Biológico: Diphtheria, tetanus, pertussis, poliomyelitis , Haemophilus influenzae type b, and hepatitis B vaccine

Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular

Outros nomes:
  • Vaxelis®
Biológico: Diphtheria, tetanus, pertussis, Haemophilus influenzae type b and poliomyelitis vaccine

Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular

Outros nomes:
  • Pentacel®
Biológico: Hepatitis B vaccine

Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular

Outros nomes:
  • RECOMBIVAX HB® ou vacina monovalente alternativa contra hepatite B
Biológico: Streptococcus pneumoniae vaccine

Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular

Outros nomes:
  • PREVNAR 20®
Biológico: Rotavirus vaccine

Pharmaceutical form:Oral solution-Route of administration:Oral

Outros nomes:
  • RotaTeq®
Biológico: Placebo

Pharmaceutical form:Liquid for nasal spray-Route of administration:Intranasal
Experimental: Cohort 1: Group 2- (RSVt vaccine non-concomitantly at 7 months)

Participants will be administered RSVt vaccine non-concomitantly with routine pediatric vaccines, 2 doses, at age 7 months. Vaccines administered at age 6 months: Vaxelis or Pentacel and Recombivax HB, Prevnar 20, and RotaTeq. Placebo will be administered concomitantly at 6 months of age
Biológico: RSVt vaccine

Pharmaceutical form:Liquid for nasal spray-Route of administration:Intranasal

Outros nomes:
  • 534
Biológico: Diphtheria, tetanus, pertussis, poliomyelitis , Haemophilus influenzae type b, and hepatitis B vaccine

Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular

Outros nomes:
  • Vaxelis®
Biológico: Diphtheria, tetanus, pertussis, Haemophilus influenzae type b and poliomyelitis vaccine

Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular

Outros nomes:
  • Pentacel®
Biológico: Hepatitis B vaccine

Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular

Outros nomes:
  • RECOMBIVAX HB® ou vacina monovalente alternativa contra hepatite B
Biológico: Streptococcus pneumoniae vaccine

Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular

Outros nomes:
  • PREVNAR 20®
Biológico: Rotavirus vaccine

Pharmaceutical form:Oral solution-Route of administration:Oral

Outros nomes:
  • RotaTeq®
Biológico: Placebo

Pharmaceutical form:Liquid for nasal spray-Route of administration:Intranasal
Experimental: Cohort 2: Group 3- (RSVt vaccine concomitantly at 12 months)

Participants will be administered RSVt vaccine concomitantly with routine pediatric vaccines, 2 doses, at age 12 months. Vaccines administered at age 6 months: M-M-R II, VARIVAX, and Prevnar 20. Placebo will be administered non-concomitantly at 13 months of age
Biológico: RSVt vaccine

Pharmaceutical form:Liquid for nasal spray-Route of administration:Intranasal

Outros nomes:
  • 534
Biológico: Streptococcus pneumoniae vaccine

Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular

Outros nomes:
  • PREVNAR 20®
Biológico: Placebo

Pharmaceutical form:Liquid for nasal spray-Route of administration:Intranasal

Biológico: Measles, mumps, and rubella vaccine

Pharmaceutical form:Lyophilized live virus for reconstitution -Route of administration:Subcutaneous or Intramuscular

Outros nomes:
  • M-M-R® II
Biológico: Varicella virus vaccine

Pharmaceutical form:Suspension for injection-Route of administration:Subcutaneous or Intramuscular

Outros nomes:
  • VARIVAX®
Experimental: Cohort 2: Group 4- (RSVt vaccine non-concomitantly at 13 months)

Participants will be administered RSVt vaccine non-concomitantly with routine pediatric vaccines, 2 doses, at age 13 months. Vaccines administered at age 6 months: M-M-R II, VARIVAX, and Prevnar 20. Placebo will be administered concomitantly at 12 months of age
Biológico: RSVt vaccine

Pharmaceutical form:Liquid for nasal spray-Route of administration:Intranasal

Outros nomes:
  • 534
Biológico: Streptococcus pneumoniae vaccine

Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular

Outros nomes:
  • PREVNAR 20®
Biológico: Placebo

Pharmaceutical form:Liquid for nasal spray-Route of administration:Intranasal

Biológico: Measles, mumps, and rubella vaccine

Pharmaceutical form:Lyophilized live virus for reconstitution -Route of administration:Subcutaneous or Intramuscular

Outros nomes:
  • M-M-R® II
Biológico: Varicella virus vaccine

Pharmaceutical form:Suspension for injection-Route of administration:Subcutaneous or Intramuscular

Outros nomes:
  • VARIVAX®

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
RSV A serum neutralizing antibody titers at 28 days post dose 2 (D85) Groups 1 and 3
Prazo: Day 85

Antibody titers at Day 85
Day 85
RSV B serum neutralizing antibody titers at 28 days post dose 2 (D85) Groups 1 and 3
Prazo: Day 85

Antibody titers at Day 85
Day 85
RSV A serum neutralizing antibody titers at Day 113 Groups 2 and 4
Prazo: Day 113

Antibody titers at Day 113
Day 113
RSV B serum neutralizing antibody titers at Day 113 Groups 2 and 4
Prazo: Day 113

Antibody titers at Day 113
Day 113

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Anti- hepatitis B surface antigen (HBsAg) Immunoglobulin g (IgG) antibody (A)b concentrations ≥ 10 milli international units per milliliter (mIU/mL) Cohort 1
Prazo: 28 days after the 6 month routine vaccinations

Antibody titers 28 days after the 6 month routine vaccinations
28 days after the 6 month routine vaccinations
Anti- polyribosylribitol phosphate (PRP) Ab concentrations ≥ 0.15 micrograms per milliliter (µg/mL) Cohort 1
Prazo: 28 days after the 6 month routine vaccinations

Antibody titers 28 days after the 6 month routine vaccinations
28 days after the 6 month routine vaccinations
Anti-poliovirus types (1, 2, and 3) Ab titers ≥ 1:8 Cohort 1
Prazo: 28 days after the 6 month routine vaccinations

Antibody titers 28 days after the 6 month routine vaccinations
28 days after the 6 month routine vaccinations
Anti-pertussis Ab concentrations pertussis toxin, filamentous hemagglutinin , pertactin, fimbriae (PT, FHA, PRN, FIM) Cohort 1
Prazo: 28 days after the 6 month routine vaccinations

Antibody titers 28 days after the 6 month routine vaccinations
28 days after the 6 month routine vaccinations
Anti-diphtheria Ab concentrations ≥ 0.1 IU/mL Cohort 1
Prazo: 28 days after the 6 month routine vaccinations

Antibody titers 28 days after the 6 month routine vaccinations
28 days after the 6 month routine vaccinations
Anti-tetanus Ab concentrations ≥ 0.1 IU/mL Cohort 1
Prazo: 28 days after the 6 month routine vaccinations

Antibody titers 28 days after the 6 month routine vaccinations
28 days after the 6 month routine vaccinations
Anti-pneumococcal Ab concentrations measured by electrochemiluminescence (ECL) for serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F and 33F Cohort 1
Prazo: 28 days after the 6 month routine vaccinations

Antibody titers 28 days after the 6 month routine vaccinations
28 days after the 6 month routine vaccinations
Anti-measles Ab concentrations ≥ 255 mIU/mL Cohort 2
Prazo: 28 days after the 12 month routine vaccinations

Antibody titers 28 days after the 12 month routine vaccinations
28 days after the 12 month routine vaccinations
Anti-mumps Ab concentrations ≥ 10 antibody units (AbU/mL) Cohort 2
Prazo: 28 days after the 12 month routine vaccinations

Antibody titers 28 days after the 12 month routine vaccinations
28 days after the 12 month routine vaccinations
Anti-rubella Ab concentrations ≥ 10 IU/mL Cohort 2
Prazo: 28 days after the 12 month routine vaccinations

Antibody titers 28 days after the 12 month routine vaccinations
28 days after the 12 month routine vaccinations
Anti-varicella Ab concentrations ≥ 5 glycoprotein enzyme-linked immunosorbent assay (gpELISA) units/mL Cohort 2
Prazo: 28 days after the 12 month routine vaccinations

Antibody 28 days after the 12 month routine vaccinations
28 days after the 12 month routine vaccinations
Anti-pneumococcal Ab concentrations measured by ECL Cohort 2
Prazo: 28 days after the 12 month routine vaccinations

Antibody titers 28 days after the 12 month routine vaccinations
28 days after the 12 month routine vaccinations
Descriptive: Anti-PRP Ab concentrations (µg/mL) Cohort 1
Prazo: 28 days after the 6 month routine vaccinations

Antibody titers 28 days after the 6 month routine vaccinations
28 days after the 6 month routine vaccinations
Descriptive: Anti-diphtheria Ab concentrations (IU/mL) Cohort 1
Prazo: 28 days after the 6 month routine vaccinations

Antibody titers 28 days after the 6 month routine vaccinations
28 days after the 6 month routine vaccinations
Descriptive: Anti-diphtheria Ab concentrations ≥ 0.01 IU/mL Cohort 1
Prazo: 28 days after the 6 month routine vaccinations

Antibody titers 28 days after the 6 month routine vaccinations
28 days after the 6 month routine vaccinations
Descriptive: Anti-tetanus Ab concentrations (IU/mL) Cohort 1
Prazo: 28 days after the 6 month routine vaccinations

Antibody titers 28 days after the 6 month routine vaccinations
28 days after the 6 month routine vaccinations
Descriptive: Anti-tetanus Ab concentrations ≥ 0.01 IU/mL Cohort 1
Prazo: 28 days after the 6 month routine vaccinations

Antibody titers 28 days after the 6 month routine vaccinations
28 days after the 6 month routine vaccinations
Descriptive: Anti-HBsAg Ab concentrations (mIU/mL) Cohort 1
Prazo: 28 days after the 6 month routine vaccinations

Antibody titers 28 days after the 6 month routine vaccinations
28 days after the 6 month routine vaccinations
Descriptive: Anti-HBsAg Ab concentrations ≥ 100 mIU/mL Cohort 1
Prazo: 28 days after the 6 month routine vaccinations

Antibody titers 28 days after the 6 month routine vaccinations
28 days after the 6 month routine vaccinations
Descriptive: Anti-poliovirus types (1, 2, and 3) Ab titers Cohort 1
Prazo: 28 days after the 6 month routine vaccinations

Antibody titers 28 days after the 6 month routine vaccinations
28 days after the 6 month routine vaccinations
Descriptive: Anti-measles Ab concentrations (mIU/mL) Cohort 2
Prazo: 28 days after the 12 month routine vaccinations

Antibody titers 28 days after the 12 month routine vaccinations
28 days after the 12 month routine vaccinations
Descriptive: Anti-mumps Ab concentrations (AbU/mL) Cohort 2
Prazo: 28 days after the 12 month routine vaccinations

Antibody titers 28 days after the 12 month routine vaccinations
28 days after the 12 month routine vaccinations
Descriptive: Anti-rubella Ab concentrations (IU/mL) Cohort 2
Prazo: 28 days after the 12 month routine vaccinations

Antibody titers 28 days after the 12 month routine vaccinations
28 days after the 12 month routine vaccinations
Descriptive: Anti-varicella Ab concentrations (gpELISA units/mL)
Prazo: 28 days after the 12 month routine vaccinations

Antibody titers 28 days after the 12 month routine vaccinations
28 days after the 12 month routine vaccinations
RSV A serum neutralizing antibody titers by baseline serostatus at Day 1 Cohort 1 and Cohort 2
Prazo: Day 1

Antibody titers at Day 1
Day 1
RSV B serum neutralizing antibody titers by baseline serostatus at Day 1 Cohort 1 and Cohort 2
Prazo: Day 1

Antibody titers at Day 1
Day 1
RSV A serum neutralizing antibody titers by baseline serostatus 28 days post-dose 2 1 Cohort 1 and Cohort 2
Prazo: 28 days post-dose 2

Antibody titers 28 days post-dose 2
28 days post-dose 2
RSV B serum neutralizing antibody titers by baseline serostatus 28 days post-dose 2 Cohort 1 and Cohort 2
Prazo: 28 days post-dose 2

Antibody titers 28 days post-dose 2
28 days post-dose 2
Presence of solicited administration site reactions within 21 days after each investigational medicinal product (IMP) administration Cohort 1 and Cohort 2
Prazo: 21 days after each IMP administration

Number of participants experiencing solicited administration site reactions
21 days after each IMP administration
Presence of solicited systemic reactions within 21 days after each IMP administration Cohort 1 and Cohort 2
Prazo: 21 days after each IMP administration

Number of participants experiencing solicited systemic site reactions
21 days after each IMP administration
Presence of unsolicited systemic adverse events (AEs) reported in the 30 minutes after each study intervention administration Cohort 1 and Cohort 2
Prazo: Within 30 minutes after each study intervention administration

Number of participants experiencing unsolicited systemic adverse events
Within 30 minutes after each study intervention administration
Presence of unsolicited AEs within 28 days after each study intervention administration Cohort 1 and Cohort 2
Prazo: Within 28 days after each study intervention administration

Number of participants experiencing unsolicited AEs
Within 28 days after each study intervention administration
Presence of medically attended adverse events (MAAEs) throughout the study Cohort 1 and Cohort 2
Prazo: Throughout the study, approximately 9 months

Number of participants experiencing MAAEs
Throughout the study, approximately 9 months
Presence of serious adverse events (SAEs) throughout the study Cohort 1 and Cohort 2
Prazo: Throughout the study, approximately 9 months

Number of participants experiencing SAEs
Throughout the study, approximately 9 months
Presence of adverse events of special interest (AESIs) throughout the study Cohort 1 and Cohort 2
Prazo: Throughout the study, approximately 9 months

Number of participants experiencing AESIs
Throughout the study, approximately 9 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Sanofi Pasteur, a Sanofi Company

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

13 de maio de 2024

Conclusão Primária (Real)

18 de setembro de 2025

Conclusão do estudo (Real)

18 de setembro de 2025

Datas de inscrição no estudo

Enviado pela primeira vez

29 de abril de 2024

Enviado pela primeira vez que atendeu aos critérios de CQ

29 de abril de 2024

Primeira postagem (Real)

3 de maio de 2024

Atualizações de registro de estudo

Última Atualização Postada (Real)

5 de outubro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

15 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • VAD00016
  • VAD00016 (Outro identificador: Sanofi Identifier)
  • U1111-1290-7356 (Identificador de registro: ICTRP)
  • 2024-000262-15 (Número EudraCT)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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