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

NCT06397768
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Phase
Phase 3
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Recruitment status
Terminated
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Participants
2,226
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Lead sponsor
Sanofi Pasteur, a Sanofi Company
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Start date
2024-05-13
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Number of sites
72
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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). 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.
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Acronym
CORAL
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Short title
Co-administration Study of an Investigational Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers
clinicaltrials.gov
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)
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Terminated
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Phase
Phase 3
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Study type
Interventional
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Reason stopped
Sponsor decision
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Completion date
2025-09-18
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First posted
2024-05-03
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Registry last updated
2026-02-03
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Primary completion date
2025-09-18
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Start date
2024-05-13
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Actual participants
2,226
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Participants
2,226
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Participant count basis
Actual
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Protocol amendments
2
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Number of sites
72
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Sanofi Pasteur, a Sanofi Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06397768
clinicaltrials.gov
ClinicalTrials.gov ID
NCT06397768
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Triple masking
Masking description
* Blinding for vaccine group assignment: participants, parents or legally acceptable representatives (LAR) and laboratory personnel at the Sponsor * No blinding for study staff who prepare and administer the study interventions, investigators or Sponsor study staff
Masked roles
Participants, Care providers, Outcome assessors
Sources for study design
clinicaltrials.gov

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

    Timeframe: Day 85

    Antibody titers at Day 85

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

    Timeframe: Day 85

    Antibody titers at Day 85

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

    Timeframe: Day 113

    Antibody titers at Day 113

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

    Timeframe: Day 113

    Antibody titers at Day 113

  1. Anti- hepatitis B surface antigen (HBsAg) Immunoglobulin g (IgG) antibody (A)b concentrations ≥ 10 milli international units per milliliter (mIU/mL) Cohort 1

    Timeframe: 28 days after the 6 month routine vaccinations

    Antibody titers 28 days after the 6 month routine vaccinations

  2. Anti- polyribosylribitol phosphate (PRP) Ab concentrations ≥ 0.15 micrograms per milliliter (µg/mL) Cohort 1

    Timeframe: 28 days after the 6 month routine vaccinations

    Antibody titers 28 days after the 6 month routine vaccinations

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

    Timeframe: 28 days after the 6 month routine vaccinations

    Antibody titers 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

    Timeframe: 28 days after the 6 month routine vaccinations

    Antibody titers 28 days after the 6 month routine vaccinations

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

    Timeframe: 28 days after the 6 month routine vaccinations

    Antibody titers 28 days after the 6 month routine vaccinations

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

    Timeframe: 28 days after the 6 month routine vaccinations

    Antibody titers 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

    Timeframe: 28 days after the 6 month routine vaccinations

    Antibody titers 28 days after the 6 month routine vaccinations

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

    Timeframe: 28 days after the 12 month routine vaccinations

    Antibody titers 28 days after the 12 month routine vaccinations

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

    Timeframe: 28 days after the 12 month routine vaccinations

    Antibody titers 28 days after the 12 month routine vaccinations

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

    Timeframe: 28 days after the 12 month routine vaccinations

    Antibody titers 28 days after the 12 month routine vaccinations

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

    Timeframe: 28 days after the 12 month routine vaccinations

    Antibody 28 days after the 12 month routine vaccinations

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

    Timeframe: 28 days after the 12 month routine vaccinations

    Antibody titers 28 days after the 12 month routine vaccinations

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

    Timeframe: 28 days after the 6 month routine vaccinations

    Antibody titers 28 days after the 6 month routine vaccinations

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

    Timeframe: 28 days after the 6 month routine vaccinations

    Antibody titers 28 days after the 6 month routine vaccinations

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

    Timeframe: 28 days after the 6 month routine vaccinations

    Antibody titers 28 days after the 6 month routine vaccinations

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

    Timeframe: 28 days after the 6 month routine vaccinations

    Antibody titers 28 days after the 6 month routine vaccinations

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

    Timeframe: 28 days after the 6 month routine vaccinations

    Antibody titers 28 days after the 6 month routine vaccinations

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

    Timeframe: 28 days after the 6 month routine vaccinations

    Antibody titers 28 days after the 6 month routine vaccinations

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

    Timeframe: 28 days after the 6 month routine vaccinations

    Antibody titers 28 days after the 6 month routine vaccinations

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

    Timeframe: 28 days after the 6 month routine vaccinations

    Antibody titers 28 days after the 6 month routine vaccinations

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

    Timeframe: 28 days after the 12 month routine vaccinations

    Antibody titers 28 days after the 12 month routine vaccinations

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

    Timeframe: 28 days after the 12 month routine vaccinations

    Antibody titers 28 days after the 12 month routine vaccinations

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

    Timeframe: 28 days after the 12 month routine vaccinations

    Antibody titers 28 days after the 12 month routine vaccinations

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

    Timeframe: 28 days after the 12 month routine vaccinations

    Antibody titers 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

    Timeframe: Day 1

    Antibody titers at Day 1

And 10 more, listed on the interactive page.

Sources for outcomes
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Sex
All
Age groups
Children
Minimum age
6 Months
Maximum age
12 Months
Healthy volunteers
Yes

  • 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.

  • 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.

Sources for eligibility
clinicaltrials.gov

  • Alabama Clinical Therapeutics - Birmingham - St. Vincent's Drive- Site Number : 8400007Birmingham, United States
  • South Alabama Medical Clinic- Site Number : 8400065Grand Bay, United States
  • MedPharmics - Mobile - Dauphin Street- Site Number : 8400017Mobile, United States
  • Northwest Arkansas Pediatric Clinic- Site Number : 8400002Fayetteville, United States
  • Alliance Research Institute - Bell Gardens - Garfield Avenue- Site Number : 8400040Bell Gardens, United States
  • Matrix Clinical Research - Huntington Park- Site Number : 8400018Huntington Park, United States
  • Paradigm Clinical Research Centers- Site Number : 8400059La Mesa, United States
  • Matrix Clinical Research - Los Angeles- Site Number : 8400008Los Angeles, United States
  • Kaiser Permanente - Oakland Medical Center- Site Number : 8400047Oakland, United States
  • Stanford University Medical Center CTRU - 800 Welch Road- Site Number : 8400070Palo Alto, United States
  • Kaiser Permanente - Sierra Gardens- Site Number : 8400063Roseville, United States
  • Kaiser Permanente - Point West Medical Offices- Site Number : 8400064Sacramento, United States
  • Kaiser Permanente - San Jose Medical Center- Site Number : 8400060San Jose, United States
  • Kaiser Permanente - Santa Clara Medical Center- Site Number : 8400061Santa Clara, United States
  • Integrated Clinical Research LLC- Site Number : 8400036Sherman Oaks, United States
  • Kaiser Permanente - Walnut Creek Medical Center- Site Number : 8400062Walnut Creek, United States
  • Velocity Clinical Research - Washington DC- Site Number : 8400050Washington D.C., United States
  • Prohealth Research Center- Site Number : 8400068Doral, United States
  • The Medici Medical Research- Site Number : 8400055Hollywood, United States
  • Dade Research Center- Site Number : 8400014Miami, United States
  • Riveldi Biomedical Research and Associates - Miami Lakes- Site Number : 8400015Miami Lakes, United States
  • SEC Clinical Research - Pensacola- Site Number : 8400034Pensacola, United States
  • PAS Research- Site Number : 8400005Tampa, United States
  • Leavitt Women's Healthcare- Site Number : 8400009Idaho Falls, United States
  • Velocity Clinical Research - Sioux City- Site Number : 8400054Sioux City, United States

And 47 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • U1111-1290-7356
  • 2024-000262-15
  • VAD00016
Sources for references
clinicaltrials.gov

Related records

Drugs (6)

Lead sponsors (1)