NCT06397768

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

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)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,226 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 6 Months – 12 Months
• Healthy volunteers: Accepted

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.

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.

Conditions

• RSV Immunization

Interventions

Type	Name	Description
BIOLOGICAL	RSVt vaccine	Pharmaceutical form:Liquid for nasal spray-Route of administration:Intranasal
BIOLOGICAL	Diphtheria, tetanus, pertussis, poliomyelitis , Haemophilus influenzae type b, and hepatitis B vaccine	Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
BIOLOGICAL	Diphtheria, tetanus, pertussis, Haemophilus influenzae type b and poliomyelitis vaccine	Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
BIOLOGICAL	Hepatitis B vaccine	Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
BIOLOGICAL	Streptococcus pneumoniae vaccine	Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
BIOLOGICAL	Rotavirus vaccine	Pharmaceutical form:Oral solution-Route of administration:Oral
BIOLOGICAL	Measles, mumps, and rubella vaccine	Pharmaceutical form:Lyophilized live virus for reconstitution -Route of administration:Subcutaneous or Intramuscular
BIOLOGICAL	Varicella virus vaccine	Pharmaceutical form:Suspension for injection-Route of administration:Subcutaneous or Intramuscular
BIOLOGICAL	Placebo	Pharmaceutical form:Liquid for nasal spray-Route of administration:Intranasal

Timeline

• Start date: 2024-05-13
• Primary completion: 2025-09-18
• Completion: 2025-09-18
• First posted: 2024-05-03
• Last updated: 2026-02-03

Locations

72 sites across 3 countries: United States, Mexico, Puerto Rico

Regulatory

• FDA-regulated drug study