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婴幼儿呼吸道合胞病毒减毒活疫苗联合给药研究 (CORAL)

2026年9月15日 更新者：Sanofi Pasteur, a Sanofi Company

III 期、随机、单盲、安慰剂对照、多中心研究，旨在评估常规儿科疫苗联合给药对健康婴儿和儿童中研究性减毒呼吸道合胞病毒 (RSV) 活疫苗抗体反应的不干扰性幼儿（珊瑚色）

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.

研究概览

地位

终止

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (实际的)

2226

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

6个月 至 1年 (孩子)

接受健康志愿者

是的

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
实验性的：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
生物：RSVt vaccine

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

其他名称：
  • 第534章
生物：Diphtheria, tetanus, pertussis, poliomyelitis , Haemophilus influenzae type b, and hepatitis B vaccine

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

其他名称：
  • Vaxelis®
生物：Diphtheria, tetanus, pertussis, Haemophilus influenzae type b and poliomyelitis vaccine

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

其他名称：
  • Pentacel®
生物：Hepatitis B vaccine

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

其他名称：
  • RECOMBIVAX HB® 或替代单价乙型肝炎疫苗
生物：Streptococcus pneumoniae vaccine

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

其他名称：
  • PREVNAR 20®
生物：Rotavirus vaccine

Pharmaceutical form:Oral solution-Route of administration:Oral

其他名称：
  • RotaTeq®
生物：Placebo

Pharmaceutical form:Liquid for nasal spray-Route of administration:Intranasal
实验性的：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
生物：RSVt vaccine

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

其他名称：
  • 第534章
生物：Diphtheria, tetanus, pertussis, poliomyelitis , Haemophilus influenzae type b, and hepatitis B vaccine

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

其他名称：
  • Vaxelis®
生物：Diphtheria, tetanus, pertussis, Haemophilus influenzae type b and poliomyelitis vaccine

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

其他名称：
  • Pentacel®
生物：Hepatitis B vaccine

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

其他名称：
  • RECOMBIVAX HB® 或替代单价乙型肝炎疫苗
生物：Streptococcus pneumoniae vaccine

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

其他名称：
  • PREVNAR 20®
生物：Rotavirus vaccine

Pharmaceutical form:Oral solution-Route of administration:Oral

其他名称：
  • RotaTeq®
生物：Placebo

Pharmaceutical form:Liquid for nasal spray-Route of administration:Intranasal
实验性的：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
生物：RSVt vaccine

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

其他名称：
  • 第534章
生物：Streptococcus pneumoniae vaccine

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

其他名称：
  • PREVNAR 20®
生物：Placebo

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

生物：Measles, mumps, and rubella vaccine

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

其他名称：
  • M-M-R® II
生物：Varicella virus vaccine

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

其他名称：
  • VARIVAX® 疫苗
实验性的：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
生物：RSVt vaccine

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

其他名称：
  • 第534章
生物：Streptococcus pneumoniae vaccine

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

其他名称：
  • PREVNAR 20®
生物：Placebo

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

生物：Measles, mumps, and rubella vaccine

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

其他名称：
  • M-M-R® II
生物：Varicella virus vaccine

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

其他名称：
  • VARIVAX® 疫苗

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
RSV A serum neutralizing antibody titers at 28 days post dose 2 (D85) Groups 1 and 3
大体时间：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
大体时间：Day 85

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

Antibody titers at Day 113
Day 113
RSV B serum neutralizing antibody titers at Day 113 Groups 2 and 4
大体时间：Day 113

Antibody titers at Day 113
Day 113

次要结果测量

结果测量
措施说明
大体时间
Anti- hepatitis B surface antigen (HBsAg) Immunoglobulin g (IgG) antibody (A)b concentrations ≥ 10 milli international units per milliliter (mIU/mL) Cohort 1
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：Throughout the study, approximately 9 months

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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Sanofi Pasteur, a Sanofi Company

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年5月13日

初级完成 (实际的)

2025年9月18日

研究完成 (实际的)

2025年9月18日

研究注册日期

首次提交

2024年4月29日

首先提交符合 QC 标准的

2024年4月29日

首次发布 (实际的)

2024年5月3日

研究记录更新

最后更新发布 (实际的)

2026年10月5日

上次提交的符合 QC 标准的更新

2026年9月15日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • VAD00016
  • VAD00016 (其他标识符：Sanofi Identifier)
  • U1111-1290-7356 (注册表标识符：ICTRP)
  • 2024-000262-15 (EudraCT编号)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

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

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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