Asphalion is proud regulatory partner of RBDCOV by carrying out the regulatory pathway throughout the project: seeking scientific advice for the RBDCOV clinical trials with the European regulatory authorities; preparing the required documents to support clinical trial applications and supporting the preparation of the eCTD registration dossier currently under rolling review, among other regulatory activities. Our participation in several EU-funded, cutting-edge projects allows us to be at the forefront of innovation and are an added value to our know-how, heightening our position in the COVID-19 vaccine development.
The RBDCOV project has started Phase III clinical trial of the Covid-19 vaccine in immunocompromised people after getting authorization from the Spanish Agency for Medicines and Health Products (AEMPS) on 9 May.
This clinical trial will determine whether an additional dose of HIPRA’s Covid-19 vaccine can generate an immune response against the virus in people living with immune system disorders, such as immunodeficiencies or who are receiving immunosuppressant treatments.
The study will involve 400 volunteers from three hospitals in Spain and three hospitals in Turkey. These are adults with pathologies or immunosuppressive conditions whose immune system may be less responsive to vaccines, including people with primary immunodeficiency.
This clinical trial, led by HIPRA, is carried out in the framework of the European-funded #RBDCOV project, which also includes clinical studies with children and adolescents.
For more details about the vaccine and the start of Phase III of the clinical trial, please have a look at the press release:
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