Co-administration Study of an Investigational Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers (CORAL)

Phase III, Randomized, Single-blind, Placebo-controlled, Multi-center Study to Evaluate Non-interference of Concomitant Administration of Routine Pediatric Vaccines on the Antibody Response of an Investigational Live-attenuated Respiratory Syncytial Virus (RSV) Vaccine in Healthy Infants and Toddlers (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.

Study Overview

• Status: Terminated
• Conditions: RSV Immunization
• Intervention / Treatment: Biological: RSVt vaccine; Biological: Diphtheria, tetanus, pertussis, poliomyelitis , Haemophilus influenzae type b, and hepatitis B vaccine; Biological: Diphtheria, tetanus, pertussis, Haemophilus influenzae type b and poliomyelitis vaccine; Biological: Hepatitis B vaccine; Biological: Streptococcus pneumoniae vaccine; Biological: Rotavirus vaccine; Biological: Placebo; Biological: Measles, mumps, and rubella vaccine; Biological: Varicella virus vaccine

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 2226
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1: Group 1- (RSVt vaccine concomitantly at 6 months); Participants will be administered RSVt vaccine concomitantly with routine pediatric vaccines, 2 doses, at age 6 months. Vaccines administered at age 6 months: RSVt Vaxelis or Pentacel and Recombivax HB, Prevnar 20, and RotaTeq. Placebo will be administered non-concomitantly at 7 months of age	Biological: RSVt vaccine; Pharmaceutical form:Liquid for nasal spray-Route of administration:Intranasal; Other Names: 534; Biological: Diphtheria, tetanus, pertussis, poliomyelitis , Haemophilus influenzae type b, and hepatitis B vaccine; Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular; Other Names: Vaxelis®; Biological: Diphtheria, tetanus, pertussis, Haemophilus influenzae type b and poliomyelitis vaccine; Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular; Other Names: Pentacel®; Biological: Hepatitis B vaccine; Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular; Other Names: RECOMBIVAX HB® or alternate monovalent hepatitis B vaccine; Biological: Streptococcus pneumoniae vaccine; Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular; Other Names: PREVNAR 20®; Biological: Rotavirus vaccine; Pharmaceutical form:Oral solution-Route of administration:Oral; Other Names: RotaTeq®; Biological: Placebo; Pharmaceutical form:Liquid for nasal spray-Route of administration:Intranasal
Experimental: Cohort 1: Group 2- (RSVt vaccine non-concomitantly at 7 months); Participants will be administered RSVt vaccine non-concomitantly with routine pediatric vaccines, 2 doses, at age 7 months. Vaccines administered at age 6 months: Vaxelis or Pentacel and Recombivax HB, Prevnar 20, and RotaTeq. Placebo will be administered concomitantly at 6 months of age	Biological: RSVt vaccine; Pharmaceutical form:Liquid for nasal spray-Route of administration:Intranasal; Other Names: 534; Biological: Diphtheria, tetanus, pertussis, poliomyelitis , Haemophilus influenzae type b, and hepatitis B vaccine; Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular; Other Names: Vaxelis®; Biological: Diphtheria, tetanus, pertussis, Haemophilus influenzae type b and poliomyelitis vaccine; Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular; Other Names: Pentacel®; Biological: Hepatitis B vaccine; Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular; Other Names: RECOMBIVAX HB® or alternate monovalent hepatitis B vaccine; Biological: Streptococcus pneumoniae vaccine; Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular; Other Names: PREVNAR 20®; Biological: Rotavirus vaccine; Pharmaceutical form:Oral solution-Route of administration:Oral; Other Names: RotaTeq®; Biological: Placebo; Pharmaceutical form:Liquid for nasal spray-Route of administration:Intranasal
Experimental: Cohort 2: Group 3- (RSVt vaccine concomitantly at 12 months); Participants will be administered RSVt vaccine concomitantly with routine pediatric vaccines, 2 doses, at age 12 months. Vaccines administered at age 6 months: M-M-R II, VARIVAX, and Prevnar 20. Placebo will be administered non-concomitantly at 13 months of age	Biological: RSVt vaccine; Pharmaceutical form:Liquid for nasal spray-Route of administration:Intranasal; Other Names: 534; Biological: Streptococcus pneumoniae vaccine; Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular; Other Names: PREVNAR 20®; Biological: Placebo; Pharmaceutical form:Liquid for nasal spray-Route of administration:Intranasal; Biological: Measles, mumps, and rubella vaccine; Pharmaceutical form:Lyophilized live virus for reconstitution -Route of administration:Subcutaneous or Intramuscular; Other Names: M-M-R® II; Biological: Varicella virus vaccine; Pharmaceutical form:Suspension for injection-Route of administration:Subcutaneous or Intramuscular; Other Names: VARIVAX®
Experimental: Cohort 2: Group 4- (RSVt vaccine non-concomitantly at 13 months); Participants will be administered RSVt vaccine non-concomitantly with routine pediatric vaccines, 2 doses, at age 13 months. Vaccines administered at age 6 months: M-M-R II, VARIVAX, and Prevnar 20. Placebo will be administered concomitantly at 12 months of age	Biological: RSVt vaccine; Pharmaceutical form:Liquid for nasal spray-Route of administration:Intranasal; Other Names: 534; Biological: Streptococcus pneumoniae vaccine; Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular; Other Names: PREVNAR 20®; Biological: Placebo; Pharmaceutical form:Liquid for nasal spray-Route of administration:Intranasal; Biological: Measles, mumps, and rubella vaccine; Pharmaceutical form:Lyophilized live virus for reconstitution -Route of administration:Subcutaneous or Intramuscular; Other Names: M-M-R® II; Biological: Varicella virus vaccine; Pharmaceutical form:Suspension for injection-Route of administration:Subcutaneous or Intramuscular; Other Names: VARIVAX®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RSV A serum neutralizing antibody titers at 28 days post dose 2 (D85) Groups 1 and 3	Antibody titers at Day 85	Day 85
RSV B serum neutralizing antibody titers at 28 days post dose 2 (D85) Groups 1 and 3	Antibody titers at Day 85	Day 85
RSV A serum neutralizing antibody titers at Day 113 Groups 2 and 4	Antibody titers at Day 113	Day 113
RSV B serum neutralizing antibody titers at Day 113 Groups 2 and 4	Antibody titers at Day 113	Day 113

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti- hepatitis B surface antigen (HBsAg) Immunoglobulin g (IgG) antibody (A)b concentrations ≥ 10 milli international units per milliliter (mIU/mL) Cohort 1	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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)	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	Antibody titers at Day 1	Day 1
RSV B serum neutralizing antibody titers by baseline serostatus at Day 1 Cohort 1 and Cohort 2	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	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	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	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	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	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	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	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	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	Number of participants experiencing AESIs	Throughout the study, approximately 9 months

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company

Publications and helpful links

Helpful Links

• VAD00016 Plain Language Results Summary

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2024
• Primary Completion (Actual): September 18, 2025
• Study Completion (Actual): September 18, 2025

Study Registration Dates

• First Submitted: April 29, 2024
• First Submitted That Met QC Criteria: April 29, 2024
• First Posted (Actual): May 3, 2024

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: January 30, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Biological Products; Complex Mixtures; Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Toxoids; Vaccines, Combined; Measles Vaccine; Viral Vaccines; Mumps Vaccine; Rubella Vaccine; Viral Hepatitis Vaccines; Herpesvirus Vaccines; Pneumococcal Vaccines; Measles-Mumps-Rubella Vaccine; Tetanus Toxoid; Herpes Zoster Vaccine; Chickenpox Vaccine; pentacel; Rotavirus Vaccines; RotaTeq; Hepatitis B Vaccines; Vaxelis; Poliovirus Vaccines; YM 534; Recombivax HB
• Other Study ID Numbers: VAD00016 (Other Identifier: Sanofi Identifier); U1111-1290-7356 (Registry Identifier: ICTRP); 2024-000262-15 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No