drugset / Trial / NCT04961541

Evaluation of the Safety and Immunogenicity of Influenza and COVID-19 Combination Vaccine

NCT04961541

Phase 1/2 Completed 637 enrolled Novavax
RandomizedParallel-groupTriple-blindPrevention

Summary

This is a randomized, observer-blinded, Phase 1/2 study evaluating the safety and immunogenicity of a quadrivalent HA nanoparticle influenza and SARS-CoV-2 rS nanoparticle combination vaccine with Matrix-M1 adjuvant; this combination is referred to as ICC vaccine.

Timeline

Start
2021-09-08
Primary completion
2021-12-22
Completion
2022-04-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Matrix-M1 Other / unclassified 50 ug Intramuscular
Subject Matrix-M1 Other / unclassified 75 ug Intramuscular
Subject SARS-CoV-2 rS Vaccine 5 ug Intramuscular
Subject qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant Vaccine 60 ug Intramuscular

Indications