EICHORCondition: COVID-19 · Sponsor: Sanofi Pasteur, a Sanofi Company
The purpose of this Phase III study is to assess the efficacy, safety, and immunogenicity of two CoV2 preS dTM-AS03 vaccines (monovalent and bivalent) as part of primary series vaccinations in a multi-stage approach, as well as a booster injection of a CoV2 preS dTM-AS03 vaccine, in adults 18 years of age and older. A total of approximately 21 046 participants are planned to be enrolled (5080 per study intervention group in Stage 1 and 5443 per study intervention group in Stage 2). Initial, double-blind, primary series study design is planned for 365 days post-last Initial injection (ie, approximately 386 days total) for each participant. Based on decisions of the Study Oversight Group, Stage 1 and Stage 2 participants will be invited to participate in an unblinded Crossover / Booster study design with duration as follows: * For participants who initially received vaccine: 12 months post-booster (ie, approximately 18 to 24 months) * For participants who initially received placebo: ≥ 4 months post-last dose of the primary series + 12 months post-booster (ie, approximately 28 to 34 months) * For participants who do not consent to continue in the unblinded Crossover / Booster part of the study, all study procedures will be stopped and participants will be discontinued from the study.
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.
Always discuss trial participation with your own doctor first.
| AES - DRS - Simon Williamson Clinic, PC - Birmingham- Site Number : 8400004 | Birmingham, Alabama, United States | — |
| Optimal Research Alabama- Site Number : 8400019 | Huntsville, Alabama, United States | — |
| Peninsula Research Associates, Inc.- Site Number : 8400021 | Rolling Hills Estates, California, United States | — |
| Synexus Clinical Research US, Inc. Site Number : 8400013 | Centennial, Colorado, United States | — |
| Optimal Research, LLC-Melbourne- Site Number : 8400002 | Melbourne, Florida, United States | — |
| Synexus Clinical Research US, Inc. - Orlando- Site Number : 8400020 | Orlando, Florida, United States | — |
| AES St. Petersburg- Site Number : 8400017 | Pinellas Park, Florida, United States | — |
| Synexus Clinical Research US, Inc. - Atlanta- Site Number : 8400005 | Atlanta, Georgia, United States | — |
| Synexus Clinical Research Chicago- Site Number : 8400012 | Chicago, Illinois, United States | — |
| Synexus Clinical Research Evansville- Site Number : 8400008 | Evansville, Indiana, United States | — |
| Synexus St. Louis- Site Number : 8400006 | St Louis, Missouri, United States | — |
| Synexus Clinical Research US, Inc. - Henderson- Site Number : 8400018 | Henderson, Nevada, United States | — |
+ 74 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT04904549