In order to perform the SHIGETECVAX activities according to institutional, national and EU guidelines and regulations, the compliance with ethics requirements will be ensured. With that aim, all required documentation, including a Data Protection Policy, Informed consent procedures and information sheets for clinical trials, among others, will be prepared and implemented during the project. Studies will start only after obtention of regulatory approval from the National Regulatory Agencies and ethics approval form the National and local Ethics Committees.