Study of a Respiratory Syncytial Virus Candidate Encapsulated in a Lipid Nanoparticle Based Formulation in Adults Aged 18 to 50 Years and 60 Years and Older
Completed · Phase 1, Phase 2 · NCT05639894
Conditions: Respiratory Syncytial Virus Immunization
At a glance
- Research payments reported, 2025
- $1.1M
- U.S. investigators named
- 22
- Sites paid
- 18
- Planned or actual enrollment
- 865
About the trial
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Tested
- RSV vaccine candidate (biological), Placebo (other)
- Dates
- Started 2022-11-17; completion 2025-05-02
- Results posted
- Yes
Brief Summary of Stage 1: The purpose of Stage 1 (Phase I/IIa) was to assess the safety and immunogenicity of a single intramuscular (IM) injection of 3 dose-levels of an Respiratory Syncytial Virus (RSV) vaccine candidate formulated with 2 different lipid nanoparticles (LNPs) in healthy adult participants aged between 18 to 50 years, and 60 years and older. The primary objectives of this stage were to assess the safety and immunogenicity profiles across the dose-level groups (low, medium, and high doses) with 2 LNPs. This stage evaluated the safety and immunogenicity of a booster vaccination administered 12 months after the primary vaccination in a subset of the study population. Brief S…
From ClinicalTrials.gov, last updated 2026-08-05. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Sanofi Pasteur Inc. reported $1.1M in research payments for this study in 2025 (146 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
- Randle T. Middleton, M.D. Family Medicine · Huntsville, AL
- Sameer K. Hassamal, MD Psychiatry · La Verne, CA
- Jeffrey S. Overcash, MD Emergency Medicine · Chula Vista, CA
- Lawrence D. Sher, M.D. Pediatrics · Rolling Hills Estates, CA
- Jorge T. Caso, MD Family Medicine · Miami, FL
- Nelia E. Sanchez-crespo, M.D. Internal Medicine · Hollywood, FL
- Daniel H. Brune, M.D. Family Medicine · Creve Coeur, IL
- Alexander Ryan, D.O. Internal Medicine · Lincoln, NE
- Seref Bornovali, MD Internal Medicine · Loveland, OH
- Sridhar Guduri, M.D Allergy & Immunology · Dublin, OH
- Margaret E. Rhee, MD OB-GYN (Obstetrics & Gynecology) · Akron, OH
- Steven E. Cox, D.O. Family Medicine · Norman, OK
- Javier O. Morales-ramirez, M.D. Infectious Disease · San Juan, PR
- Jeffrey Quinones, MD, MBA Pediatrics · Guayama, PR
- David Fried, MD Internal Medicine · East Greenwich, RI
- Shannon M. Conrad, D.O. Family Medicine · N Charleston, SC
- Sadeer Alkindi, M.D. Cardiology · Houston, TX
- Charles P. Andrews, M.D. Pulmonology · San Antonio, TX
- Mark D. Carlson, MD Internal Medicine · Cedar Park, TX
- Tiffany M. Huynh, MD Orthopedic Surgery · Houston, TX
- Earl F. Martin, MD Family Medicine · Tomball, TX
- Sarah I. Smiley, D.O. Hospitalist · Austin, TX
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Velocity Clinical Research,inc $631,482
- Peninsula Headlands Llc $102,635
- Suncoast Research Associates Llc $76,062
- Research Centers of America $71,232
- Research Centers of America,llc $54,709
- Dynamed Clinical Research,lp $37,448
- Velocity Clinical Research $26,309
- Be Well Clinical Studies Llc $23,296
- Uh Cleveland Medical Center, OH $22,500
- Clinical Research Puerto Rico,inc $18,675
- Cr Services Acquisition Us Llc $15,420
- Lynn Helath Science Inst $13,706
- Suncoast Research Associates, Llc $12,361
- Ima Research San Antonio $12,150
- Healthagen Llc $7,600
- The Children's Mercy Hospital, MO $7,500
- Clinical Research Advantage Inc $3,836
- Coastal Carolina Research Center,incorporation $1,200
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.