Trial to enrol up to 30,000 volunteers worldwide
Fast Track designation granted by US FDA
Medicago, a biopharmaceutical company headquartered in Quebec City, and GlaxoSmithKline (GSK) are pleased to announce the start of Phase 3 clinical testing of Medicago’s plant-derived COVID-19 vaccine candidate in combination with GSK’s pandemic adjuvant, as part of the ongoing Phase 2/3 study. Medicago received approval from Canadian and US regulatory authorities to proceed with enrolment of healthy adults in the Phase 3 portion of the trial based on positive interim Phase 2 results.
“We are pleased to take the significant step of initiating the Phase 3 clinical trial at sites around the world,” said Takashi Nagao, CEO and President of Medicago. “This brings us one step closer to delivering an important new COVID-19 vaccine and contributing to the global fight against the pandemic along with our partner GSK.”
GSK and Medicago initiate late-stage COVID-19 vaccine study
Plant-based, adjuvanted vaccine candidate received FDA fast track designation in February
GlaxoSmithKline (GSK) and Medicago have started phase 3 clinical testing of their plant-based adjuvanted COVID-19 vaccine.
The phase 3 study will evaluate two 3.75 micrograms doses of the vaccine candidate, administered 21 days apart.
Initially, it will enrol up to 30,000 participants including healthy adults aged 18 to 65 years old, after which older adults aged 65 years and up and adults with comorbidities will also be included.
In a statement, Medicago said it had received approval from Canadian and US regulatory authorities to proceed with enrolment in the late-stage study based on positive interim phase 2 results.
Medicago and GSK Start Phase 3 Trial of Adjuvanted COVID-19 Vaccine Candidate
Fast Track designation granted by US FDA
Feasibility study initiated of a vaccine candidate to address emerging variants
Medicago, a biopharmaceutical company headquartered in Quebec City, and GlaxoSmithKline (GSK) are pleased to announce the start of Phase 3 clinical testing of Medicago s plant-derived COVID-19 vaccine candidate in combination with GSK s pandemic adjuvant, as part of the ongoing Phase 2/3 study. Medicago received approval from Canadian and US regulatory authorities to proceed with enrollment of healthy adults in the Phase 3 portion of the trial based on positive interim Phase 2 results. In parallel, Medicago has also initiated a feasibility study of a vaccine candidate to address the emerging COVID-19 variants.
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