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

About the trial

Sponsor

Sanofi Pasteur, a Sanofi Company

Tested

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), Measles, mumps, and rubella vaccine (biological), Varicella virus vaccine (biological), Placebo (biological)

Dates

Started 2024-05-13; completion 2025-09-18

Results posted

Not yet

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-…

From ClinicalTrials.gov, last updated 2026-10-05. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Sanofi Pasteur Inc. reported $1.3M in research payments for this study in 2025 (221 payments).

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.