Study: NCT01623232

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: MAS-1 adjuvant and influenza HA antigen
Description: Vaccines will be administered IM in the deltoid muscle. HA antigen of each of three viral strains at doses of 1 micrograms, 3 micrograms, or 5 micrograms per viral strain adjuvanted with MAS-1 adjuvant and as nonadjuvanted standard dose TIV will be tested.~1. Treatment Group 1:each 0.3 mL dose will be administered as an emulsion containing 0.186 grams of MAS-1 oil vehicle and 1 micrograms HA of each of three viral strains in 0.08 mL sterile phosphate buffered saline (PBS).~2. Treatment Group 2:each 0.3 mL dose will be administered as an emulsion containing 0.186 grams of MAS-1 oil vehicle and 3 micrograms HA of each of three viral strains in 0.08 mL sterile PBS.~3. Treatment Group 3:each 0.3 mL dose will be administered as an emulsion containing 0.186 grams of MAS-1 oil vehicle and 5 micrograms HA of each of three viral strains in 0.08 mL sterile PBS.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: MAS-1 adjuvant and influenza HA antigen
Description: Vaccines will be administered IM in the deltoid muscle. HA antigen of each of three viral strains at doses of 1 micrograms, 3 micrograms, or 5 micrograms per viral strain adjuvanted with MAS-1 adjuvant and as nonadjuvanted standard dose TIV will be tested.~1. Treatment Group 1:each 0.3 mL dose will be administered as an emulsion containing 0.186 grams of MAS-1 oil vehicle and 1 micrograms HA of each of three viral strains in 0.08 mL sterile phosphate buffered saline (PBS).~2. Treatment Group 2:each 0.3 mL dose will be administered as an emulsion containing 0.186 grams of MAS-1 oil vehicle and 3 micrograms HA of each of three viral strains in 0.08 mL sterile PBS.~3. Treatment Group 3:each 0.3 mL dose will be administered as an emulsion containing 0.186 grams of MAS-1 oil vehicle and 5 micrograms HA of each of three viral strains in 0.08 mL sterile PBS.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: MAS-1 adjuvant and influenza HA antigen
Description: Vaccines will be administered IM in the deltoid muscle. HA antigen of each of three viral strains at doses of 1 micrograms, 3 micrograms, or 5 micrograms per viral strain adjuvanted with MAS-1 adjuvant and as nonadjuvanted standard dose TIV will be tested.~1. Treatment Group 1:each 0.3 mL dose will be administered as an emulsion containing 0.186 grams of MAS-1 oil vehicle and 1 micrograms HA of each of three viral strains in 0.08 mL sterile phosphate buffered saline (PBS).~2. Treatment Group 2:each 0.3 mL dose will be administered as an emulsion containing 0.186 grams of MAS-1 oil vehicle and 3 micrograms HA of each of three viral strains in 0.08 mL sterile PBS.~3. Treatment Group 3:each 0.3 mL dose will be administered as an emulsion containing 0.186 grams of MAS-1 oil vehicle and 5 micrograms HA of each of three viral strains in 0.08 mL sterile PBS.

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: standard dose, inactivated trivalent influenza vaccine (TIV)
Description: Vaccine will be administered IM in the deltoid muscle. HA antigen of each of three viral strains as nonadjuvanted standard dose TIV will be tested.~4. Treatment Group 4:0.5 mL dose of licensed, unadjuvanted, standard dose influenza virus vaccine with 15 micrograms HA of each of 3 viral strains.