Condition: Respiratory Syncytial Virus Immunization · Sponsor: Sanofi Pasteur, a Sanofi Company
Brief Summary of Stage 1: The purpose Stage 1 (Phase I/IIa) is 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 are to assess the safety and immunogenicity profiles across the dose-level groups (low, medium, and high doses) with 2 LNPs. This stage will evaluate the safety and immunogenicity of a booster vaccination administered 12 months after the primary vaccination in a subset of the study population. Brief Summary of Stage 2: The study also also incorporates a Stage 2 (Phase IIa, dose-ranging design) that includes adults aged 60 years and older to assess the safety and immunogenicity of different doses of RSV vaccine encapsulated in one of the LNPs. In the Phase IIa dose-ranging stage, eligible participants will be randomly assigned in a 1:1:1 ratio to receive a single IM administration of RSV vaccine candidate doses, or placebo. Multiple safety analyses will be performed, minimally at D07 and D28. Additional analyses may be performed as data are available.
This description comes directly from the study's public registry record.
Contact details are listed per location below or on the registry record.
Always discuss trial participation with your own doctor first.
| Optimal Research Alabama Site Number : 8400032 | Huntsville, Alabama, United States | — |
| Aventiv Research Mesa Site Number : 8400020 | Mesa, Arizona, United States | — |
| CVS Health - Peoria Site Number : 8400042 | Peoria, Arizona, United States | — |
| CVS Health - Phoenix Site Number : 8400041 | Phoenix, Arizona, United States | — |
| Velocity Clinical Research - San Diego - ERN - PPDS Site Number : 8400010 | La Mesa, California, United States | — |
| Peninsula Research Associates Site Number : 8400013 | Rolling Hills Estates, California, United States | — |
| CVS Health - Thousand Oaks Site Number : 8400043 | Thousand Oaks, California, United States | — |
| Cenexel Research Centers of America Site Number : 8400024 | Hollywood, Florida, United States | — |
| Suncoast Research Associates, LLC Site Number : 8400003 | Miami, Florida, United States | — |
| Centricity Research - Georgia Site Number : 8400009 | Rincon, Georgia, United States | — |
| AES Peoria Site Number : 8400030 | Peoria, Illinois, United States | — |
| DM Clinical Research - Chicago Site Number : 8400027 | River Forest, Illinois, United States | — |
+ 21 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05639894