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Imeväisille ja taaperoille tehdyn elävien heikennettyjen hengitysteiden synsytiaalivirusrokotteen yhteisannostaminen (CORAL)

tiistai 15. syyskuuta 2026 päivittänyt: Sanofi Pasteur, a Sanofi Company

Vaihe III, satunnaistettu, yksisokkoutettu, lumekontrolloitu, monikeskustutkimus, jolla arvioitiin, ettei tavanomaisten lasten rokotteiden samanaikainen anto häiritse elävien heikennettyjen hengitysteiden syntiaalivirusrokotteen (RSV) vasta-ainevastetta terveillä vauvoilla ja vauvoilla Taaperot (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.

Tutkimuksen yleiskatsaus

Tila

Lopetettu

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

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.

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

2226

Vaihe

  • Vaihe 3

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

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

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

6 kuukautta - 1 vuosi (Lapsi)

Hyväksyy terveitä vapaaehtoisia

Joo

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

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.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Ennaltaehkäisy
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Kolminkertaistaa

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: 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
Biologinen: RSVt vaccine

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

Muut nimet:
  • 534
Biologinen: Diphtheria, tetanus, pertussis, poliomyelitis , Haemophilus influenzae type b, and hepatitis B vaccine

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

Muut nimet:
  • Vaxelis®
Biologinen: Diphtheria, tetanus, pertussis, Haemophilus influenzae type b and poliomyelitis vaccine

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

Muut nimet:
  • Pentacel®
Biologinen: Hepatitis B vaccine

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

Muut nimet:
  • RECOMBIVAX HB® tai vaihtoehtoinen monovalenttinen hepatiitti B -rokote
Biologinen: Streptococcus pneumoniae vaccine

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

Muut nimet:
  • PREVNAR 20®
Biologinen: Rotavirus vaccine

Pharmaceutical form:Oral solution-Route of administration:Oral

Muut nimet:
  • RotaTeq®
Biologinen: Placebo

Pharmaceutical form:Liquid for nasal spray-Route of administration:Intranasal
Kokeellinen: 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
Biologinen: RSVt vaccine

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

Muut nimet:
  • 534
Biologinen: Diphtheria, tetanus, pertussis, poliomyelitis , Haemophilus influenzae type b, and hepatitis B vaccine

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

Muut nimet:
  • Vaxelis®
Biologinen: Diphtheria, tetanus, pertussis, Haemophilus influenzae type b and poliomyelitis vaccine

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

Muut nimet:
  • Pentacel®
Biologinen: Hepatitis B vaccine

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

Muut nimet:
  • RECOMBIVAX HB® tai vaihtoehtoinen monovalenttinen hepatiitti B -rokote
Biologinen: Streptococcus pneumoniae vaccine

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

Muut nimet:
  • PREVNAR 20®
Biologinen: Rotavirus vaccine

Pharmaceutical form:Oral solution-Route of administration:Oral

Muut nimet:
  • RotaTeq®
Biologinen: Placebo

Pharmaceutical form:Liquid for nasal spray-Route of administration:Intranasal
Kokeellinen: 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
Biologinen: RSVt vaccine

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

Muut nimet:
  • 534
Biologinen: Streptococcus pneumoniae vaccine

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

Muut nimet:
  • PREVNAR 20®
Biologinen: Placebo

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

Biologinen: Measles, mumps, and rubella vaccine

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

Muut nimet:
  • M-M-R® II
Biologinen: Varicella virus vaccine

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

Muut nimet:
  • VARIVAX®
Kokeellinen: 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
Biologinen: RSVt vaccine

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

Muut nimet:
  • 534
Biologinen: Streptococcus pneumoniae vaccine

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

Muut nimet:
  • PREVNAR 20®
Biologinen: Placebo

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

Biologinen: Measles, mumps, and rubella vaccine

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

Muut nimet:
  • M-M-R® II
Biologinen: Varicella virus vaccine

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

Muut nimet:
  • VARIVAX®

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
RSV A serum neutralizing antibody titers at 28 days post dose 2 (D85) Groups 1 and 3
Aikaikkuna: 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
Aikaikkuna: Day 85

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

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

Antibody titers at Day 113
Day 113

Toissijaiset tulostoimenpiteet

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

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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Sanofi Pasteur, a Sanofi Company

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Hyödyllisiä linkkejä

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Maanantai 13. toukokuuta 2024

Ensisijainen valmistuminen (Todellinen)

Torstai 18. syyskuuta 2025

Opintojen valmistuminen (Todellinen)

Torstai 18. syyskuuta 2025

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Maanantai 29. huhtikuuta 2024

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Maanantai 29. huhtikuuta 2024

Ensimmäinen Lähetetty (Todellinen)

Perjantai 3. toukokuuta 2024

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Maanantai 5. lokakuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Tiistai 15. syyskuuta 2026

Viimeksi vahvistettu

Tiistai 1. syyskuuta 2026

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • VAD00016
  • VAD00016 (Muu tunniste: Sanofi Identifier)
  • U1111-1290-7356 (Rekisterin tunniste: ICTRP)
  • 2024-000262-15 (EudraCT-numero)

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

JOO

IPD-suunnitelman kuvaus

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

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Joo

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Ei

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

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