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

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.

Conditions

• RSV Immunization

Interventions

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

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

12 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-05-13

Primary Completion

2025-09-18

Completion

2025-09-18

FDA Drug

Yes

Countries

• United States
• Mexico
• Puerto Rico

Study Locations