AzTrials
AzTrials

RSV ImmunizationPhase 3CORALNCT06397768

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

A Phase 3 study testing RSVt vaccine, Diphtheria, tetanus, pertussis, poliomyelitis , Haemophilus influenzae type b, and hepatitis B vaccine and Diphtheria, tetanus, pertussis, Haemophilus influenzae type b and poliomyelitis vaccine in people with RSV Immunization, run by Sanofi Pasteur, a Sanofi Company at 72 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 6 to 12 monthsHealthy volunteers can take part
Conditions the study is for
RSV Immunization
What is being tested?
RSVt vaccine, Diphtheria, tetanus, pertussis, poliomyelitis , Haemophilus influenzae type b, and hepatitis B vaccine and Diphtheria, tetanus, pertussis, Haemophilus influenzae type b and poliomyelitis vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,226 participants
Where
72 sitesin 3 countries
Study dates
13 May 2024to 18 Sep 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 12 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 24Show fewer
  • 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.

Trial locations and contacts

72 sites in 3 countries.

72 sites in 3 countries

United States66 sites

  • Alliance Research Institute - Bell Gardens - Garfield Avenue- Site Number : 8400040

    Bell Gardens, California, 90201

  • Alabama Clinical Therapeutics - Birmingham - St. Vincent's Drive- Site Number : 8400007

    Birmingham, Alabama, 35205

  • Neighbors Pediatrics- Site Number : 8400072

    Charleston, South Carolina, 29407

  • South Texas Clinical Research- Site Number : 8400004

    Corpus Christi, Texas, 78413

  • Javara - Privia Medical Group North Texas - Dallas- Site Number : 8400003

    Dallas, Texas, 75230

  • Dayton Clinical Research- Site Number : 8400030

    Dayton, Ohio, 45409

  • Ohio Pediatrics - Dayton- Site Number : 8400033

    Dayton, Ohio, 45414

  • Prohealth Research Center- Site Number : 8400068

    Doral, Florida, 33166

  • PAS Research - Children's Care Clinic- Site Number : 8400035

    Edinburg, Texas, 78539

  • Alliance for Multispeciality Research - El Dorado- Site Number : 8400019

    El Dorado, Kansas, 67042

  • Square-1 Clinical Research- Site Number : 8400031

    Erie, Pennsylvania, 16506

  • Northwest Arkansas Pediatric Clinic- Site Number : 8400002

    Fayetteville, Arkansas, 72703

  • Helios Clinical Research - Fort Worth - 8th Avenue- Site Number : 8400020

    Fort Worth, Texas, 76104

  • NYU Langone Cardiothoracic Surgery Associates - Garden City- Site Number : 8400048

    Garden City, New York, 11530

  • South Alabama Medical Clinic- Site Number : 8400065

    Grand Bay, Alabama, 36541

  • Velocity Clinical Research - Grand Island- Site Number : 8400016

    Grand Island, Nebraska, 68803

  • Boeson Research - Great Falls- Site Number : 8400041

    Great Falls, Montana, 59405

  • Tribe Clinical Research - Greenville - Verdae Boulevard- Site Number : 8400012

    Greenville, South Carolina, 29607

  • Cyn3rgy Research- Site Number : 8400053

    Gresham, Oregon, 97030

  • Velocity Clinical Research - Gulfport- Site Number : 8400011

    Gulfport, Mississippi, 39503

  • PAS Research - Henderson- Site Number : 8400049

    Henderson, Nevada, 89014

  • The Medici Medical Research- Site Number : 8400055

    Hollywood, Florida, 33021

  • Ventavia Research Group - Houston - North Loop West- Site Number : 8400010

    Houston, Texas, 77008

  • The University of Texas Health Science Center- Site Number : 8400037

    Houston, Texas, 77030

  • DM Clinical Research - Houston - Jones Road- Site Number : 8400052

    Houston, Texas, 77065

  • Mercury Clinical Research - Houston - Savoy Drive- Site Number : 8400045

    Houston, Texas, 77070

  • La Providence Pediatrics & Family Clinics- Site Number : 8400039

    Houston, Texas, 77071

  • Houston Clinical Research Associates- Site Number : 8400013

    Houston, Texas, 77090

  • Matrix Clinical Research - Huntington Park- Site Number : 8400018

    Huntington Park, California, 90255

  • Leavitt Women's Healthcare- Site Number : 8400009

    Idaho Falls, Idaho, 83404

  • Paradigm Clinical Research Centers- Site Number : 8400059

    La Mesa, California, 91942

  • University of Texas Medical Branch at Galveston- Site Number : 8400057

    League City, Texas, 77555

  • Maximos Ob/Gyn- Site Number : 8400024

    League City, Texas, 77573

  • University of Kentucky Chandler Medical Center- Site Number : 8400051

    Lexington, Kentucky, 40536

  • Midwest Childrens Health Research Institute- Site Number : 8400038

    Lincoln, Nebraska, 68516

  • Summerwood Pediatrics- Site Number : 8400021

    Liverpool, New York, 13088

  • Matrix Clinical Research - Los Angeles- Site Number : 8400008

    Los Angeles, California, 90057

  • Dade Research Center- Site Number : 8400014

    Miami, Florida, 33126

  • Riveldi Biomedical Research and Associates - Miami Lakes- Site Number : 8400015

    Miami Lakes, Florida, 33014

  • Boeson Research - Missoula- Site Number : 8400006

    Missoula, Montana, 59804

  • MedPharmics - Mobile - Dauphin Street- Site Number : 8400017

    Mobile, Alabama, 36608

  • Velocity Clinical Research - New Orleans- Site Number : 8400058

    New Orleans, Louisiana, 70119

  • Research Works INC- Site Number : 8400044

    New Orleans, Louisiana, 70125

  • Kaiser Permanente - Oakland Medical Center- Site Number : 8400047

    Oakland, California, 94611

  • Velocity Clinical Research - Omaha- Site Number : 8400001

    Omaha, Nebraska, 68134

  • Utah Valley Pediatrics - Orem- Site Number : 8400067

    Orem, Utah, 84057

  • Stanford University Medical Center CTRU - 800 Welch Road- Site Number : 8400070

    Palo Alto, California, 94304

  • SEC Clinical Research - Pensacola- Site Number : 8400034

    Pensacola, Florida, 32501

  • Pas Research - Pittsburgh- Site Number : 8400043

    Pittsburgh, Pennsylvania, 15227

  • Research Your Health- Site Number : 8400066

    Plano, Texas, 75093

  • Ogden Clinic - Mountain View - CCT Research- Site Number : 8400056

    Pleasant View, Utah, 84404

  • Pediatric Center - Richmond- Site Number : 8400032

    Richmond, Texas, 77469

  • Kaiser Permanente - Sierra Gardens- Site Number : 8400063

    Roseville, California, 95661

  • Wee Care Pediatrics - Roy- Site Number : 8400071

    Roy, Utah, 84067

  • Kaiser Permanente - Point West Medical Offices- Site Number : 8400064

    Sacramento, California, 95815

  • Kaiser Permanente - San Jose Medical Center- Site Number : 8400060

    San Jose, California, 95119

  • Kaiser Permanente - Santa Clara Medical Center- Site Number : 8400061

    Santa Clara, California, 95051

  • Integrated Clinical Research LLC- Site Number : 8400036

    Sherman Oaks, California, 91356-4173

  • Velocity Clinical Research - Sioux City- Site Number : 8400054

    Sioux City, Iowa, 51106

  • Senders Pediatrics- Site Number : 8400022

    South Euclid, Ohio, 44121

  • QPS Bio-Kinetic Clinical Applications- Site Number : 8400046

    Springfield, Missouri, 65802

  • SUNY Upstate Medical University - Syracuse- Site Number : 8400029

    Syracuse, New York, 13210

  • PAS Research- Site Number : 8400005

    Tampa, Florida, 33613

  • North Houston Internal Medicine & Pediatric Clinic- Site Number : 8400025

    Tomball, Texas, 77375

  • Kaiser Permanente - Walnut Creek Medical Center- Site Number : 8400062

    Walnut Creek, California, 94596

  • Velocity Clinical Research - Washington DC- Site Number : 8400050

    Washington D.C., District of Columbia, 20016

Other trials in United States

Mexico3 sites

  • Investigational Site Number : 4840001

    Mexico City, Mexico City, 04530

  • Investigational Site Number : 4840004

    Mexico City, 06760

  • Investigational Site Number : 4840002

    Temixco, Morelos, 62587

Other trials in Mexico

Puerto Rico3 sites

  • Investigational Site Number : 6300001

    Caguas, 00725

  • Investigational Site Number : 6300003

    Ponce, 00716

  • Investigational Site Number : 6300004

    Trujillo Alto, 00976

Other trials in Puerto Rico

About this study

Official title: 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.

Read the 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.
Being tested
RSVt vaccine, Diphtheria, tetanus, pertussis, poliomyelitis , Haemophilus influenzae type b, and hepatitis B vaccine, Diphtheria, tetanus, pertussis, Haemophilus influenzae type b and poliomyelitis vaccine, Hepatitis B vaccine, Streptococcus pneumoniae vaccine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RSVt vaccineBiological

    Also called 534

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

  • Diphtheria, tetanus, pertussis, poliomyelitis , Haemophilus influenzae type b, and hepatitis B vaccineBiological

    Also called Vaxelis®

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

  • Diphtheria, tetanus, pertussis, Haemophilus influenzae type b and poliomyelitis vaccineBiological

    Also called Pentacel®

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

  • Hepatitis B vaccineBiological

    Also called RECOMBIVAX HB® or alternate monovalent hepatitis B vaccine

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

  • Streptococcus pneumoniae vaccineBiological

    Also called PREVNAR 20®

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

  • Rotavirus vaccineBiological

    Also called RotaTeq®

    Pharmaceutical form:Oral solution-Route of administration:Oral

  • Measles, mumps, and rubella vaccineBiological

    Also called M-M-R® II

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

  • Varicella virus vaccineBiological

    Also called VARIVAX®

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

  • PlaceboBiological

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

Study groups in NCT06397768
Study groupRoleWhat they receive
Cohort 1: Group 1- (RSVt vaccine concomitantly at 6 months)ExperimentalParticipants 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
Receives: 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
Cohort 1: Group 2- (RSVt vaccine non-concomitantly at 7 months)ExperimentalParticipants 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
Receives: 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
Cohort 2: Group 3- (RSVt vaccine concomitantly at 12 months)ExperimentalParticipants 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
Receives: Biological: RSVt vaccine; Biological: Streptococcus pneumoniae vaccine; Biological: Measles, mumps, and rubella vaccine; Biological: Varicella virus vaccine; Biological: Placebo
Cohort 2: Group 4- (RSVt vaccine non-concomitantly at 13 months)ExperimentalParticipants 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
Receives: Biological: RSVt vaccine; Biological: Streptococcus pneumoniae vaccine; Biological: Measles, mumps, and rubella vaccine; Biological: Varicella virus vaccine; Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. RSV A serum neutralizing antibody titers at 28 days post dose 2 (D85) Groups 1 and 3

    Antibody titers at Day 85

    Measured: Day 85

  2. RSV B serum neutralizing antibody titers at 28 days post dose 2 (D85) Groups 1 and 3

    Antibody titers at Day 85

    Measured: Day 85

  3. RSV A serum neutralizing antibody titers at Day 113 Groups 2 and 4

    Antibody titers at Day 113

    Measured: Day 113

  4. RSV B serum neutralizing antibody titers at Day 113 Groups 2 and 4

    Antibody titers at Day 113

    Measured: Day 113

Secondary outcomes (35)

  1. 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

    Measured: 28 days after the 6 month routine vaccinations

  2. 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

    Measured: 28 days after the 6 month routine vaccinations

  3. Anti-poliovirus types (1, 2, and 3) Ab titers ≥ 1:8 Cohort 1

    Antibody titers 28 days after the 6 month routine vaccinations

    Measured: 28 days after the 6 month routine vaccinations

  4. 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

    Measured: 28 days after the 6 month routine vaccinations

  5. Anti-diphtheria Ab concentrations ≥ 0.1 IU/mL Cohort 1

    Antibody titers 28 days after the 6 month routine vaccinations

    Measured: 28 days after the 6 month routine vaccinations

  6. Anti-tetanus Ab concentrations ≥ 0.1 IU/mL Cohort 1

    Antibody titers 28 days after the 6 month routine vaccinations

    Measured: 28 days after the 6 month routine vaccinations

  7. 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

    Measured: 28 days after the 6 month routine vaccinations

  8. Anti-measles Ab concentrations ≥ 255 mIU/mL Cohort 2

    Antibody titers 28 days after the 12 month routine vaccinations

    Measured: 28 days after the 12 month routine vaccinations

  9. Anti-mumps Ab concentrations ≥ 10 antibody units (AbU/mL) Cohort 2

    Antibody titers 28 days after the 12 month routine vaccinations

    Measured: 28 days after the 12 month routine vaccinations

  10. Anti-rubella Ab concentrations ≥ 10 IU/mL Cohort 2

    Antibody titers 28 days after the 12 month routine vaccinations

    Measured: 28 days after the 12 month routine vaccinations

  11. Anti-varicella Ab concentrations ≥ 5 glycoprotein enzyme-linked immunosorbent assay (gpELISA) units/mL Cohort 2

    Antibody 28 days after the 12 month routine vaccinations

    Measured: 28 days after the 12 month routine vaccinations

  12. Anti-pneumococcal Ab concentrations measured by ECL Cohort 2

    Antibody titers 28 days after the 12 month routine vaccinations

    Measured: 28 days after the 12 month routine vaccinations

  13. Descriptive: Anti-PRP Ab concentrations (µg/mL) Cohort 1

    Antibody titers 28 days after the 6 month routine vaccinations

    Measured: 28 days after the 6 month routine vaccinations

  14. Descriptive: Anti-diphtheria Ab concentrations (IU/mL) Cohort 1

    Antibody titers 28 days after the 6 month routine vaccinations

    Measured: 28 days after the 6 month routine vaccinations

  15. Descriptive: Anti-diphtheria Ab concentrations ≥ 0.01 IU/mL Cohort 1

    Antibody titers 28 days after the 6 month routine vaccinations

    Measured: 28 days after the 6 month routine vaccinations

  16. Descriptive: Anti-tetanus Ab concentrations (IU/mL) Cohort 1

    Antibody titers 28 days after the 6 month routine vaccinations

    Measured: 28 days after the 6 month routine vaccinations

  17. Descriptive: Anti-tetanus Ab concentrations ≥ 0.01 IU/mL Cohort 1

    Antibody titers 28 days after the 6 month routine vaccinations

    Measured: 28 days after the 6 month routine vaccinations

  18. Descriptive: Anti-HBsAg Ab concentrations (mIU/mL) Cohort 1

    Antibody titers 28 days after the 6 month routine vaccinations

    Measured: 28 days after the 6 month routine vaccinations

  19. Descriptive: Anti-HBsAg Ab concentrations ≥ 100 mIU/mL Cohort 1

    Antibody titers 28 days after the 6 month routine vaccinations

    Measured: 28 days after the 6 month routine vaccinations

  20. Descriptive: Anti-poliovirus types (1, 2, and 3) Ab titers Cohort 1

    Antibody titers 28 days after the 6 month routine vaccinations

    Measured: 28 days after the 6 month routine vaccinations

  21. Descriptive: Anti-measles Ab concentrations (mIU/mL) Cohort 2

    Antibody titers 28 days after the 12 month routine vaccinations

    Measured: 28 days after the 12 month routine vaccinations

  22. Descriptive: Anti-mumps Ab concentrations (AbU/mL) Cohort 2

    Antibody titers 28 days after the 12 month routine vaccinations

    Measured: 28 days after the 12 month routine vaccinations

  23. Descriptive: Anti-rubella Ab concentrations (IU/mL) Cohort 2

    Antibody titers 28 days after the 12 month routine vaccinations

    Measured: 28 days after the 12 month routine vaccinations

  24. Descriptive: Anti-varicella Ab concentrations (gpELISA units/mL)

    Antibody titers 28 days after the 12 month routine vaccinations

    Measured: 28 days after the 12 month routine vaccinations

  25. RSV A serum neutralizing antibody titers by baseline serostatus at Day 1 Cohort 1 and Cohort 2

    Antibody titers at Day 1

    Measured: Day 1

  26. RSV B serum neutralizing antibody titers by baseline serostatus at Day 1 Cohort 1 and Cohort 2

    Antibody titers at Day 1

    Measured: Day 1

  27. 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

    Measured: 28 days post-dose 2

  28. 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

    Measured: 28 days post-dose 2

  29. 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

    Measured: 21 days after each IMP administration

  30. 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

    Measured: 21 days after each IMP administration

  31. 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

    Measured: Within 30 minutes after each study intervention administration

  32. Presence of unsolicited AEs within 28 days after each study intervention administration Cohort 1 and Cohort 2

    Number of participants experiencing unsolicited AEs

    Measured: Within 28 days after each study intervention administration

  33. Presence of medically attended adverse events (MAAEs) throughout the study Cohort 1 and Cohort 2

    Number of participants experiencing MAAEs

    Measured: Throughout the study, approximately 9 months

  34. Presence of serious adverse events (SAEs) throughout the study Cohort 1 and Cohort 2

    Number of participants experiencing SAEs

    Measured: Throughout the study, approximately 9 months

  35. Presence of adverse events of special interest (AESIs) throughout the study Cohort 1 and Cohort 2

    Number of participants experiencing AESIs

    Measured: Throughout the study, approximately 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2024
  2. Study start13 May 2024
  3. Primary completion18 Sep 2025
  4. Study completion18 Sep 2025

Why it stopped: Sponsor decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
2,226 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06397768
Sponsor's protocol ID
VAD00016
Other IDs
VAD00016, U1111-1290-7356, 2024-000262-15
Acronym
CORAL
Status last verified
Sep 2026
First submitted
29 Apr 2024
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing RSVt vaccine, Diphtheria, tetanus, pertussis, poliomyelitis , Haemophilus influenzae type b, and hepatitis B vaccine and Diphtheria, tetanus, pertussis, Haemophilus influenzae type b and poliomyelitis vaccine in people with RSV Immunization, run by Sanofi Pasteur, a Sanofi Company at 72 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in United States, Mexico, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

RSV A serum neutralizing antibody titers at 28 days post dose 2 (D85) Groups 1 and 3 (time frame: Day 85). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06397768.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.

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