Novavax

Sponsor: Novavax/CoVPN Coordinating Center/CRO: ICON

Gov ID NCT04368988

Primary Objective: To evaluate the efficacy of a paimary 2-dose regimen of SARS-CoV-2 rS adjuvanted with Matrix-M1 compared to placebo against polymerase chain reaction (PCR)-confirmed symptomatic coronavirus disease 2019 (COVID-19) illness diagnosed ≥ 7 days after completion of the second vaccination in adult participants ≥ 18 years of age. 

Study Drug: SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) with Matrix-M1™Adjuvant vs placebo; 2 doses active drug and 2 doses placebo

Final enrollment: 176 enrolled; 140 fully vaccinated with 4 doses of study drug; 63 boosted so far Study Progress: Enrollment complete, initial vaccination period complete; crossover complete; top level results announced; submission to FDA for EUA finally sent on 1/31/22. Administration of boosters started 1/20/22 at Med Drive and RBG. One more scheduled dosing day. Subsequent visits at 28,120,240 and 360 days post booster.

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