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Virus Therapy

RSV Vaccine for Infants and Toddlers (CORAL Trial)

Phase 3
Recruiting
Research Sponsored by Sanofi Pasteur, a Sanofi Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Must not have
History of definitive contraindications to concomitant vaccines
Probable or confirmed ongoing case of viral respiratory infection at the time of enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout the study, approximately 9 months
Awards & highlights
Pivotal Trial

Summary

This trial will test a vaccine for respiratory syncytial virus (RSV) in healthy infants and toddlers. The study will look at whether giving the RSV vaccine at the same time as routine vaccines

Who is the study for?
This trial is for healthy infants and toddlers who are either 6 months + 2 weeks or 12 months ± 2 weeks old, born at full term (≥37 weeks). In the US/Puerto Rico, they must have received specific routine vaccines on schedule before joining. Infants with health issues or not meeting vaccine timelines are excluded.
What is being tested?
The study tests if the RSVt vaccine's effectiveness is unaffected when given alongside standard childhood vaccines like DTP, IPV, Hib, HepB, rotavirus and pneumococcal conjugate vaccines at ages of approximately 6 and 12 months compared to giving it separately.
What are the potential side effects?
Potential side effects aren't specified but may include typical reactions to vaccinations such as soreness at injection site, fever, irritability in infants/toddlers post-immunization. Serious adverse events will be monitored.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot receive certain vaccines due to severe reactions or allergies.
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I currently have a viral respiratory infection.
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I have a weak immune system or have been on strong immune-suppressing drugs recently.
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I have had an RSV infection before.
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I have received RSV antibodies.
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I have not had a fever or been sick in the last 2 days.
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I have a medical history of wheezing.
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I have had infections with specific diseases before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout the study, approximately 9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout the study, approximately 9 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
RSV A serum neutralizing antibody titers at 28 days post dose 2 (D85) Groups 1 and 3
RSV A serum neutralizing antibody titers at Day 113 Groups 2 and 4
RSV B serum neutralizing antibody titers at 28 days post dose 2 (D85) Groups 1 and 3
+1 more
Secondary study objectives
Anti- hepatitis B surface antigen (HBsAg) Immunoglobulin g (IgG) antibody (A)b concentrations ≥ 10 milli international units per milliliter (mIU/mL) Cohort 1
Anti- polyribosylribitol phosphate (PRP) Ab concentrations ≥ 0.15 micrograms per milliliter (µg/mL) Cohort 1
Anti-diphtheria Ab concentrations ≥ 0.1 IU/mL Cohort 1
+32 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort 2: Group 4- (RSVt vaccine non-concomitantly at 13 months)Experimental Treatment5 Interventions
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
Group II: Cohort 2: Group 3- (RSVt vaccine concomitantly at 12 months)Experimental Treatment5 Interventions
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
Group III: Cohort 1: Group 2- (RSVt vaccine non-concomitantly at 7 months)Experimental Treatment7 Interventions
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
Group IV: Cohort 1: Group 1- (RSVt vaccine concomitantly at 6 months)Experimental Treatment7 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hepatitis B vaccine
1999
Completed Phase 4
~118560
Measles, mumps, and rubella vaccine
2011
Completed Phase 3
~2320
Rotavirus vaccine
2011
Completed Phase 4
~3290
Placebo
1995
Completed Phase 3
~2670

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Who is running the clinical trial?

Sanofi Pasteur, a Sanofi CompanyLead Sponsor
416 Previous Clinical Trials
6,105,182 Total Patients Enrolled
1 Trials studying Respiratory Syncytial Virus Immunization
865 Patients Enrolled for Respiratory Syncytial Virus Immunization
~1391 spots leftby Sep 2025
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