Study: NCT03300050

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: cH8/1N1 LAIV
Description: Live-attenuated influenza virus vaccine (LAIV) expressing chimeric hemagglutinin (HA) with the H8 head and H1 stalk and neuraminidase (NA) subtype 1 (N1) (cH8/1N1):~HA head, A/mallard/Sweden/24/2002 (H8N4); HA stalk, A/California/04/2009 (H1N1); NA, A/California/04/2009 (H1N1) containing the backbone of the cold-adapted/temperature sensitive of the Russian LAIV A/Leningrad/134/17/1957 (Len17 IDCDCRG46D).~Administered intranasally as drops at a dose of 10⁷·⁵ (plus or minus ⁰·⁵) 50% egg infectious dose (EID50), formulated in a total volume of 0.5 mL sterile saline (0.25 mL per nostril).

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: cH8/1N1 LAIV
Description: Live-attenuated influenza virus vaccine (LAIV) expressing chimeric hemagglutinin (HA) with the H8 head and H1 stalk and neuraminidase (NA) subtype 1 (N1) (cH8/1N1):~HA head, A/mallard/Sweden/24/2002 (H8N4); HA stalk, A/California/04/2009 (H1N1); NA, A/California/04/2009 (H1N1) containing the backbone of the cold-adapted/temperature sensitive of the Russian LAIV A/Leningrad/134/17/1957 (Len17 IDCDCRG46D).~Administered intranasally as drops at a dose of 10⁷·⁵ (plus or minus ⁰·⁵) 50% egg infectious dose (EID50), formulated in a total volume of 0.5 mL sterile saline (0.25 mL per nostril).

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: AS03-adjuvanted cH5/1N1 IIV
Description: Chimeric H5 head with H1 stalk plus N1 (cH5/1N1) split virion inactivated influenza virus vaccine (IIV) plus AS03 adjuvant: HA head, A/Vietnam/1203/2004 (H5N1); HA stalk, A/California/04/2009 (H1N1); NA, A/California/04/2009 (H1N1).~Administered intramuscularly at a dose of 15 μg of hemagglutinin in a volume of 0.5 mL of phosphate buffered saline (PBS).

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: AS03-adjuvanted cH5/1N1 IIV
Description: Chimeric H5 head with H1 stalk plus N1 (cH5/1N1) split virion inactivated influenza virus vaccine (IIV) plus AS03 adjuvant: HA head, A/Vietnam/1203/2004 (H5N1); HA stalk, A/California/04/2009 (H1N1); NA, A/California/04/2009 (H1N1).~Administered intramuscularly at a dose of 15 μg of hemagglutinin in a volume of 0.5 mL of phosphate buffered saline (PBS).

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: cH5/1N1 IIV
Description: Chimeric H5 head with H1 stalk plus N1 (cH5/1N1) split virion inactivated influenza virus vaccine (IIV):~HA head, A/Vietnam/1203/2004 (H5N1); HA stalk, A/California/04/2009 (H1N1); NA, A/California/04/2009 (H1N1).~Administered intramuscularly at a dose of 15 μg of hemagglutinin in a volume of 0.5 mL of phosphate buffered saline (PBS).

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: AS03-adjuvanted cH8/1N1 IIV
Description: Chimeric H8 head with H1 stalk plus N1 (cH8/1N1) inactivated influenza vaccine plus AS03 adjuvant: HA head, A/mallard/Sweden/24/2002 (H8N4); HA stalk, A/California/04/2009 (H1N1); NA, A/California/04/2009 (H1N1).~Administered intramuscularly at a dose of 15 μg of hemagglutinin in a volume of 0.5 mL of phosphate buffered saline (PBS).

Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Normal saline
Description: Administered intranasally as 0.25 mL nasal drops per nostril

Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Phosphate buffered saline (PBS)
Description: Administered intramuscularly as 0.5 mL injection

Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Phosphate buffered saline (PBS)
Description: Administered intramuscularly as 0.5 mL injection