Sanatorio Allende reported that as of this June it is participating in an international clinical trial that aims to “evaluate the safety and capacity of a research-stage influenza vaccine in adults over 18 years of age, developed by the American pharmaceutical company Moderna which is in its phase III investigation.
They stressed that “in recent years there has been an exponential increase in the number of cases of seasonal flu, both in Argentina and in the world and, although there are currently approved vaccines to prevent severe forms of the disease and reduce mortality from this infection, science seeks to find new options that could be more effective than existing ones.
It uses messenger RNA (same as Moderna’s COVID-19 vaccine), which will allow it to adapt more quickly to ever-changing annual strains. It will be administered in a single dose. It will be compared with another quadrivalent influenza vaccine currently used in our country. Those who qualify as volunteers will be randomly assigned to one of the two arms of the study, that is, they will receive the modern investigational vaccine or the previously approved quadrivalent vaccine. It involves a process of monitoring and evaluation of the participants for a year.
They detailed that the study will be carried out in health centers in five countries in Latin America and Asia-Pacific. In Argentina, approximately 3,500 participants will be recruited and Sanatorio Allende plans to select around 500 volunteers.
They added that, “in order to carry out this investigation, a call will be opened for those who want to apply as candidates, provided they meet the established requirements. In other words, since there are certain inclusion criteria, not all the people nominated will be able to participate as volunteers.”
General requirements:
Being over 18 years.
If you are female, NOT be pregnant or plan to become pregnant for at least 3 months after receiving this vaccine.
NOT have received a flu shot in the last 6 months.
NOT have received any vaccinations in the last 28 days.
NOT be participating in another clinical trial.
The staff in charge of the clinical trial will explain in detail the more specific requirements of the study and will answer any questions that may arise.
They further clarified that:
Participation in this trial is voluntary and unpaid.
This study is carried out in accordance with Good Clinical Practices, in addition to being evaluated and approved by ANMAT and an Ethics Committee made up of experts. All this to confirm that the safety of the participants is being constantly monitored.
There is no cost to participate in this study. All visits, tests, examinations and investigational seasonal influenza vaccine, as long as they are related to the study, will be provided to the volunteer at no cost, including transportation to and from the Sanatorium.