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Estudio de coadministración de una vacuna en investigación contra el virus respiratorio sincitial vivo atenuado en bebés y niños pequeños (CORAL)

15 de septiembre de 2026 actualizado por: Sanofi Pasteur, a Sanofi Company

Fase III, estudio multicéntrico, aleatorizado, simple ciego, controlado con placebo para evaluar la no interferencia de la administración concomitante de vacunas pediátricas de rutina en la respuesta de anticuerpos de una vacuna en investigación contra el virus sincitial respiratorio (VSR) vivo atenuado en bebés sanos y Niños pequeños (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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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 estudio

Intervencionista

Inscripción (Actual)

2226

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • 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
  • Puerto Rico
      • Caguas, Puerto Rico, 00725
        • Investigational Site Number : 6300001
      • Ponce, Puerto Rico, 00716
        • Investigational Site Number : 6300003
      • Trujillo Alto, Puerto Rico, 00976
        • Investigational Site Number : 6300004

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

6 meses a 1 año (Niño)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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

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

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

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

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

Otros nombres:
  • Pentacel®
Biológico: Hepatitis B vaccine

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

Otros nombres:
  • RECOMBIVAX HB® o vacuna monovalente alternativa contra la hepatitis B
Biológico: Streptococcus pneumoniae vaccine

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

Otros nombres:
  • PREVNAR 20®
Biológico: Rotavirus vaccine

Pharmaceutical form:Oral solution-Route of administration:Oral

Otros nombres:
  • 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

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

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

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

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

Otros nombres:
  • Pentacel®
Biológico: Hepatitis B vaccine

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

Otros nombres:
  • RECOMBIVAX HB® o vacuna monovalente alternativa contra la hepatitis B
Biológico: Streptococcus pneumoniae vaccine

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

Otros nombres:
  • PREVNAR 20®
Biológico: Rotavirus vaccine

Pharmaceutical form:Oral solution-Route of administration:Oral

Otros nombres:
  • 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

Otros nombres:
  • 534
Biológico: Streptococcus pneumoniae vaccine

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

Otros nombres:
  • 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

Otros nombres:
  • M-M-R® II
Biológico: Varicella virus vaccine

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

Otros nombres:
  • 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

Otros nombres:
  • 534
Biológico: Streptococcus pneumoniae vaccine

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

Otros nombres:
  • 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

Otros nombres:
  • M-M-R® II
Biológico: Varicella virus vaccine

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

Otros nombres:
  • VARIVAX®

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
RSV A serum neutralizing antibody titers at 28 days post dose 2 (D85) Groups 1 and 3
Periodo de tiempo: 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
Periodo de tiempo: Day 85

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

Antibody titers at Day 113
Day 113
RSV B serum neutralizing antibody titers at Day 113 Groups 2 and 4
Periodo de tiempo: Day 113

Antibody titers at Day 113
Day 113

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Anti- hepatitis B surface antigen (HBsAg) Immunoglobulin g (IgG) antibody (A)b concentrations ≥ 10 milli international units per milliliter (mIU/mL) Cohort 1
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Throughout the study, approximately 9 months

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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Sanofi Pasteur, a Sanofi Company

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

13 de mayo de 2024

Finalización primaria (Actual)

18 de septiembre de 2025

Finalización del estudio (Actual)

18 de septiembre de 2025

Fechas de registro del estudio

Enviado por primera vez

29 de abril de 2024

Primero enviado que cumplió con los criterios de control de calidad

29 de abril de 2024

Publicado por primera vez (Actual)

3 de mayo de 2024

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

15 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

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

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan 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

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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