A Study on the Immunogenicity and Safety of 3 Different Dose Concentrations of a Respiratory Syncytial Virus Vaccine in Infants and Toddlers
Terminated · Phase 3 · NCT06705140
Conditions: RSV Immunisation, Healthy Volunteers
At a glance
- Research payments reported, 2025
- $176,552
- U.S. investigators named
- 13
- Sites paid
- 12
- Planned or actual enrollment
- 42
About the trial
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Tested
- Low Dose (LD) RSVt vaccine (biological), Standard Dose (SD) RSVt vaccine (biological), High Dose (HD) RSVt vaccine (biological), Placebo (biological)
- Dates
- Started 2024-11-25; completion 2025-06-11
- Results posted
- Yes
This study was a Phase III, parallel group, randomized, observer blind, placebo controlled, multi-national, multi-center, multi-arm study conducted in 42 healthy children enrolled at 6 months to \<22 months of age. The purpose of the study was to evaluate the non-inferiority of the immune response of the lower dose (LD) when compared to the standard dose (SD) respiratory syncytial virus infant and toddler (RSVt) vaccine and the safety of the LD, SD and high dose (HD) vaccine in preterm born children and of the HD vaccine in full term born children administered by intranasal route and compared to placebo.
From ClinicalTrials.gov, last updated 2026-08-03. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Sanofi Pasteur Inc. reported $176,552 in research payments for this study in 2025 (71 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.
U.S. investigators named on this study
- Shaun S. Berger Pediatrics · San Diego, CA
- Giselle Deiros, MD Pediatrics · Miami, FL
- Karen A. Kelly, MD Pediatrics · Clearwater, FL
- Lance E. Slade, M.D. Pediatrics · Macon, GA
- Glenn R. Leavitt, DO OB-GYN (Obstetrics & Gynecology) · Idaho Falls, ID
- Gary W. Soucie, MD Family Medicine · Blackfoot, ID
- Daniel J. Finn, MD Pediatrics · Bardstown, KY
- Michael W. Simon, M.D. Pediatrics · Nicholasville, KY
- Jeffrey Quinones, MD, MBA Pediatrics · Guayama, PR
- Nicolas Rosario Matos, M.D. Pediatrics · Bayamon, PR
- Scott Dobson, M.D. Pediatrics · Simpsonville, SC
- Philip J. Mcgaha, MD Pediatrics · Charleston, SC
- Robert C. Bell, M.D. Pediatrics · Beaumont, TX
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Paradigm Clinical Research Centers, Inc $27,770
- Tribe Clinical Research Llc Mountain View Clinical Research $26,534
- Velocity Clinical Research,inc $17,767
- Tekton Research Fredericksburg Road $14,700
- Acevedo Clinical Research Associates Co $13,856
- Kentucky Pediatric Adult Research $12,034
- Leavitt Clinical Research Inc $12,007
- $9,381
- Elite Clinical Trials Blackfoot $9,034
- Physicians Administrative Solutions Llc $9,034
- Michael W Simon,md,psc $9,034
- Clinical Research Puerto Rico,inc $7,901
- Clinical Research Investigator Group Llc $7,500
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.