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Efficacy, Immunogenicity, and Safety Study of a Respiratory Syncytial Virus Vaccine in Infants and Toddlers

Terminated · Phase 3 · NCT06252285

Conditions: RSV Immunisation

At a glance

Research payments reported, 2025
$4.6M
U.S. investigators named
68
Sites paid
56
Planned or actual enrollment
6,300

About the trial

Sponsor
Sanofi Pasteur, a Sanofi Company
Tested
RSVt Vaccine (biological), Placebo (biological)
Dates
Started 2024-02-06; completion 2025-12-04
Results posted
Not yet

This study is a phase III, randomized, observer-blind, placebo-controlled, multinational, multi-center study to be conducted in approximately 6300 children 6 months to \< 22 months of age. The purpose of the study is to evaluate the efficacy, immunogenicity, and safety of Respiratory Syncytial Virus Toddler (RSVt) vaccine administered by intranasal route compared to placebo. Eligible participants will be randomized in a 1:1 ratio to receive 2 intranasal administrations of either the RSVt vaccine or placebo. Study duration will be 24 months for each participant. The safety follow-up will start after the first vaccination and up to the end of the study.

From ClinicalTrials.gov, last updated 2026-02-03. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Sanofi Pasteur Inc. reported $4.6M in research payments for this study in 2025 (638 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

Clinicians the company named as principal investigators in its Open Payments reports.

Sites paid to run it

  • Michigan Institute of Research $1.1M
  • Wirbcopernicus Group Inc $924,188
  • Alliance for Multispecialty Research,llc $264,572
  • Emory University Hospital, GA $247,219
  • Be Well Clinical Studies Llc $239,967
  • $182,663
  • Cedar Health Research $182,593
  • Clinical Research Prime $165,025
  • Wcg Clinical Inc Krm Group Llc $126,761
  • California Research Foundation $88,932
  • Pediatric Research of Charlottesville $67,470
  • Clinical Research Prime Rexburg Llc $66,347
  • Dynamed Clinical Research,lp $61,613
  • Boeson Research $61,238
  • Velocity Clinical Research,inc $51,352
  • Neutra Life Sciences Llc $50,919
  • Helios Cr, Inc $50,894
  • Dr Shelly David Senders MD Inc $50,436
  • Children's Hospital Colorado, CO $46,619
  • Caribbean Medical Research Center Llc $45,229
  • Pediatric Medical Research of Charlottesville $44,635
  • Clinical Research Associates,inc $33,537
  • Integrated Clinical Research Llc $31,274
  • Palmetto Pediatrics,pa $31,045
  • Cincinnati Children's Hospital Medical Center, OH $30,622
  • Snake River Research,pllc $26,445
  • Uprrecinto De Ciencias Medicas $24,808
  • Lakeview Clinical Research $23,963
  • Physicians Administrative Solutions Llc $22,783
  • Renown Regional Medical Center, NV $21,183
  • Cenexel Iresearch Llc $16,927
  • Johns Hopkins University Johns Hopkins Technology Ventures $16,317
  • Johns Hopkins University $14,693
  • Palm Beach Research Center $14,275
  • Clinical Research Institute $13,753
  • Tekton Research Fredericksburg Road $13,125
  • Clinical Research Puerto Rico,inc $10,836
  • Cyn3rgy Research $10,075
  • Central Research Associates Inc $9,390
  • Morehouse School of Medicine Inc $9,039
  • Palm Harbor Dermatology PA PAlm Harbor Dermatology PA Dba True Clinical Research $8,233
  • Medical University of South Carolina $8,204
  • Medical University of South Carolina Health Neurology $7,962
  • Imagine Research of PAlm Beach County $7,500
  • Boston Medical Center, MA $7,500
  • Clinical Research Investigator Group Llc $7,352
  • Boeson Research Llc $6,672
  • Great Lakes Research Institute Llc $6,669
  • D and H Doral Research Center $6,650
  • Bassem Maximos MD Mph PA $6,389
  • Oakland Hills Dermatology PC $5,800
  • Natl Institute of Clinical Research $5,286
  • University Clinical Research Dela Llc $5,061
  • Agile Clinical Research Trials LLC $5,027
  • Madera Family Medical Group $2,000
  • Moore Clinical Research $1,496
  • Moore Clnical Research Inc $880

Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.