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Samadministrasjonsstudie av en undersøkende vaksine for levende svekket respiratorisk syncytialvirus hos spedbarn og småbarn (CORAL)

15. september 2026 oppdatert av: Sanofi Pasteur, a Sanofi Company

Fase III, randomisert, enkeltblind, placebokontrollert, multisenterstudie for å evaluere ikke-interferens av samtidig administrering av rutinemessige pediatriske vaksiner på antistoffresponsen til en undersøkelsesvaksine med levende svekket respiratorisk syncytialvirus (RSV) hos friske spedbarn og Småbarn (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.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

2226

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

6 måneder til 1 år (Barn)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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
Biologisk: RSVt vaccine

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

Andre navn:
  • 534
Biologisk: Diphtheria, tetanus, pertussis, poliomyelitis , Haemophilus influenzae type b, and hepatitis B vaccine

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

Andre navn:
  • Vaxelis®
Biologisk: Diphtheria, tetanus, pertussis, Haemophilus influenzae type b and poliomyelitis vaccine

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

Andre navn:
  • Pentacel®
Biologisk: Hepatitis B vaccine

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

Andre navn:
  • RECOMBIVAX HB® eller alternativ monovalent hepatitt B-vaksine
Biologisk: Streptococcus pneumoniae vaccine

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

Andre navn:
  • PREVNAR 20®
Biologisk: Rotavirus vaccine

Pharmaceutical form:Oral solution-Route of administration:Oral

Andre navn:
  • RotaTeq®
Biologisk: Placebo

Pharmaceutical form:Liquid for nasal spray-Route of administration:Intranasal
Eksperimentell: 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
Biologisk: RSVt vaccine

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

Andre navn:
  • 534
Biologisk: Diphtheria, tetanus, pertussis, poliomyelitis , Haemophilus influenzae type b, and hepatitis B vaccine

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

Andre navn:
  • Vaxelis®
Biologisk: Diphtheria, tetanus, pertussis, Haemophilus influenzae type b and poliomyelitis vaccine

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

Andre navn:
  • Pentacel®
Biologisk: Hepatitis B vaccine

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

Andre navn:
  • RECOMBIVAX HB® eller alternativ monovalent hepatitt B-vaksine
Biologisk: Streptococcus pneumoniae vaccine

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

Andre navn:
  • PREVNAR 20®
Biologisk: Rotavirus vaccine

Pharmaceutical form:Oral solution-Route of administration:Oral

Andre navn:
  • RotaTeq®
Biologisk: Placebo

Pharmaceutical form:Liquid for nasal spray-Route of administration:Intranasal
Eksperimentell: 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
Biologisk: RSVt vaccine

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

Andre navn:
  • 534
Biologisk: Streptococcus pneumoniae vaccine

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

Andre navn:
  • PREVNAR 20®
Biologisk: Placebo

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

Biologisk: Measles, mumps, and rubella vaccine

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

Andre navn:
  • M-M-R® II
Biologisk: Varicella virus vaccine

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

Andre navn:
  • VARIVAX®
Eksperimentell: 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
Biologisk: RSVt vaccine

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

Andre navn:
  • 534
Biologisk: Streptococcus pneumoniae vaccine

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

Andre navn:
  • PREVNAR 20®
Biologisk: Placebo

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

Biologisk: Measles, mumps, and rubella vaccine

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

Andre navn:
  • M-M-R® II
Biologisk: Varicella virus vaccine

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

Andre navn:
  • VARIVAX®

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
RSV A serum neutralizing antibody titers at 28 days post dose 2 (D85) Groups 1 and 3
Tidsramme: 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
Tidsramme: Day 85

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

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

Antibody titers at Day 113
Day 113

Sekundære resultatmål

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

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Sanofi Pasteur, a Sanofi Company

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

13. mai 2024

Primær fullføring (Faktiske)

18. september 2025

Studiet fullført (Faktiske)

18. september 2025

Datoer for studieregistrering

Først innsendt

29. april 2024

Først innsendt som oppfylte QC-kriteriene

29. april 2024

Først lagt ut (Faktiske)

3. mai 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • VAD00016
  • VAD00016 (Annen identifikator: Sanofi Identifier)
  • U1111-1290-7356 (Registeridentifikator: ICTRP)
  • 2024-000262-15 (EudraCT-nummer)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere