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Samadministreringsstudie av ett undersökande levande försvagat respiratoriskt syncytialvirusvaccin hos spädbarn och småbarn (CORAL)

15 september 2026 uppdaterad av: Sanofi Pasteur, a Sanofi Company

Fas III, randomiserad, enkelblind, placebokontrollerad, multicenterstudie för att utvärdera icke-interferens av samtidig administrering av rutinmässiga pediatriska vacciner på antikroppssvaret av ett undersökningsvaccin med levande försvagat respiratoriskt syncytialvirus (RSV) hos friska spädbarn och Småbarn (KORALL)

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

2226

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

6 månader till 1 år (Barn)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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

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

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

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

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

Andra namn:
  • Pentacel®
Biologisk: Hepatitis B vaccine

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

Andra namn:
  • RECOMBIVAX HB® eller alternativt monovalent hepatit B-vaccin
Biologisk: Streptococcus pneumoniae vaccine

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

Andra namn:
  • PREVNAR 20®
Biologisk: Rotavirus vaccine

Pharmaceutical form:Oral solution-Route of administration:Oral

Andra namn:
  • RotaTeq®
Biologisk: Placebo

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

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

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

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

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

Andra namn:
  • Pentacel®
Biologisk: Hepatitis B vaccine

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

Andra namn:
  • RECOMBIVAX HB® eller alternativt monovalent hepatit B-vaccin
Biologisk: Streptococcus pneumoniae vaccine

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

Andra namn:
  • PREVNAR 20®
Biologisk: Rotavirus vaccine

Pharmaceutical form:Oral solution-Route of administration:Oral

Andra namn:
  • RotaTeq®
Biologisk: Placebo

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

Andra namn:
  • 534
Biologisk: Streptococcus pneumoniae vaccine

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

Andra namn:
  • 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

Andra namn:
  • M-M-R® II
Biologisk: Varicella virus vaccine

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

Andra namn:
  • VARIVAX®
Experimentell: 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

Andra namn:
  • 534
Biologisk: Streptococcus pneumoniae vaccine

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

Andra namn:
  • 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

Andra namn:
  • M-M-R® II
Biologisk: Varicella virus vaccine

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

Andra namn:
  • VARIVAX®

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
RSV A serum neutralizing antibody titers at 28 days post dose 2 (D85) Groups 1 and 3
Tidsram: 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
Tidsram: Day 85

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

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

Antibody titers at Day 113
Day 113

Sekundära resultatmått

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

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Sanofi Pasteur, a Sanofi Company

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

13 maj 2024

Primärt slutförande (Faktisk)

18 september 2025

Avslutad studie (Faktisk)

18 september 2025

Studieregistreringsdatum

Först inskickad

29 april 2024

Först inskickad som uppfyllde QC-kriterierna

29 april 2024

Första postat (Faktisk)

3 maj 2024

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

5 oktober 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

15 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • VAD00016
  • VAD00016 (Annan identifierare: Sanofi Identifier)
  • U1111-1290-7356 (Registeridentifierare: ICTRP)
  • 2024-000262-15 (EudraCT-nummer)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera