EICHORCondition: Human Metapneumovirus Immunization · Respiratory Syncytial Virus Immunization · Sponsor: Sanofi Pasteur, a Sanofi Company
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The aim of this study is to evaluate the safety and immunogenicity of a human metapneumovirus (hMPV) / respiratory syncytial virus (RSV) mRNA vaccine candidate encapsulated in a lipid nanoparticle (LNP) based formulation (hereafter referred to as hMPV/RSV vaccine) for the prevention of lower respiratory tract disease (LRTD) caused by hMPV and/or RSV among adults aged 60 years and older. The study will also evaluate the safety and immunogenicity of a booster vaccination using a bivalent hMPV/RSV mRNA vaccine candidate (hereafter referred to as RSV+hMPV mRNA vaccine candidate). Overall, the study is designed to address the following goals: * Assess the safety profile of the candidate formulations. * Describe the immunogenicity profile of the candidate formulations. * Select the vaccine formulations (dose) for future development. * Assess the safety and immunogenicity of a booster vaccination with the RSV + hMPV mRNA vaccine candidate administered 12 months after primary vaccination with a licensed RSV vaccine. The study duration is as follows: -Six months each for the Sentinel and Main Cohorts; up to 12 months for the Expansion Cohort, and 6 additional months for the Booster Cohort Treatment duration: * Stage 1 Sentinel Cohort: 1 intra-muscular (IM) injection. Participants will be followed for 6 months post vaccination * Stage 1 Main Cohort: 1 IM injection. Participants will be followed for 6 months post vaccination * Stage 2 Expansion Cohort: 1 IM injection. Participant…
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
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| Velocity Clinical Research, Phoenix- Site Number : 8400025 | Phoenix, Arizona, United States | — |
| CenExel CNS-Garden Grove- Site Number : 8400017 | Garden Grove, California, United States | — |
| National Research Institute - Gardena- Site Number : 8400005 | Gardena, California, United States | — |
| National Research Institute - Huntington Park- Site Number : 8400014 | Huntington Park, California, United States | — |
| Velocity Clinical Research - San Diego- Site Number : 8400008 | La Mesa, California, United States | — |
| Velocity Clinical Research Los Angeles- Site Number : 8400013 | Los Angeles, California, United States | — |
| National Research Institute - Panorama City- Site Number : 8400012 | Los Angeles, California, United States | — |
| Providence Clinical Research - North Hollywood- Site Number : 8400018 | North Hollywood, California, United States | — |
| Peninsula Research Associates- Site Number : 8400002 | Rolling Hills Estates, California, United States | — |
| Velocity Clinical Research - Denver- Site Number : 8400016 | Englewood, Colorado, United States | — |
| Velocity Clinical Research - Washington DC- Site Number : 8400007 | Washington D.C., District of Columbia, United States | — |
| Velocity Clinical Research - Hallandale Beach- Site Number : 8400022 | Hallandale, Florida, United States | — |
+ 12 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06686654