definiens: means a formulation intended to be administered in a formulation containing one or more Antigen(s)(and / or a nucleic acid sequence encoding an Antigen ) in the form of ( i ) an infectious agent ( e.g., bacteria, viruses, parasite, protozoa ) whether live, attenuated or dead, ( ii ) protein(s ), ( iii ) nucleic acid(s ), ( iv ) cells, spores and vectors ( i.e., viruses and / orvirus - like particles, liposomes, beads and/or other substrates for Antigen presentation ), ( v ) fragments of any of the foregoing, and/or ( vi ) a combination of any of the preceding, which formulation is administered for the purpose of inducing an ImmuneResponse in the human and/or animal recipient specifically directed to at least one such Antigen for the prevention ortreatment of a disease state, symptom and/or condition in humans and/or animals caused by an infectious agent . For thepurposes of this definition of Vaccine:(a ) means a molecule ( i.e., protein, polypeptide, peptide, carbohydrate, glycoprotein, glycolipid and / orany combination of the foregoing that is, or is derived in whole or part from, a molecule associated with an infectious agent)that produces an Immune Response to such molecule in a human and/or animal recipient