Vaccination
ID93 is a recombinant subunit antigen, and GLA-SE is a squalene emulsion containing the synthetic Toll-like receptor 4 agonist glucopyranosyl lipid A (GLA)Study vaccine preparation, including vaccine dilutions and admixing for the two dosing groups, was performed by the unblinded site pharmacist using an aseptic technique on the same day of study vaccine administration but no more than 2 h prior to administration. Once reconstituted, the vaccine from both treatment groups (single- and two-vial presentations) looked identical. The designee assigned to administer the study injections was supplied with a loaded syringe labeled with the participant identification number and hospital-required identification data. The time of preparation and time of administration was noted in the source documentation. All study injections were 0.5 mL in volume and administered intramuscularly in the deltoid of the non-dominant arm.