Guidelines for Nonclinical Studies of Preventive Vaccines for Infectious Diseases (PFSB/ELD Notification No. 0527-1, dated May 27, 2010)1) and Guidelines for Clinical Studies of Preventive Vaccines for Infectious Diseases (PFSB/ELD Notification No. 0527-5, dated May 27, 2010)2) can be used for reference.