Clinical trials Medicago

Strict study protocol

Clinical trials are at the heart of vaccine research. Their goal is to ensure that an experimental vaccine will be safe and effective.

All vaccine candidates developed by Medicago undergo clinical trials and follow a very strict study protocol. Conducted by independent doctors or hospital teams, clinical trials are performed in four successive phases:

Phase I

Trials are carried out on a limited number of healthy subjects under strict medical supervision. The purpose of Phase I trials is to assess the safety of the vaccine candidate and its potential adverse effects.

Phase II

The aim of Phase II trials is to test the efficacy of the vaccine candidate and determine the optimal dose (dosage). They involve two groups: one that is given the vaccine candidate and the other a placebo.

Phase III

Phase III trials are conducted on a large number of people in several clinical trial centres. Their purpose is to compare the therapeutic efficacy of the vaccine candidate against the placebo and collect additional safety data. Neither the patient nor the medical team knows which product each clinical trial subject is given.

Phase IV

Once marketing authorization is obtained, Phase IV trials are conducted throughout the vaccine commercialization phase. One purpose of phase IV trials is to identify potential rare adverse events or unexpectedly high rates of common adverse events, a process known as pharmacovigilance. Phase IV trials help define the conditions of use for certain groups of at-risk patients and assess the effects of possible drug interactions.

Health Canada. Clinical trials and drug safety. Accessed February 2022.