Safety, Tolerability, and Efficacy Study of Prophylactic S. Pneumoniae Vaccine Following Challenge With S. Pneumoniae

"GEN-004: 100 µg of each antigen, with adjuvant, 350 µg aluminum hydroxide, administered as a 0.5 mL intramuscular (IM) injection.~GEN-004 is a recombinant S. pneumoniae protein subunit vaccine consisting of 3 recombinant T cell antigens:~* GB104: ABC transporter, substrate-binding protein~* GB144: Maltose/maltodextrin binding protein, ABC transporter~* GB152: Hypothetical protein~GEN-004 is filled in 2 mL vials containing 0.5 mL (350 µg/mL of each antigen).~Aluminum hydroxide adjuvant is filled in 2 mL vials containing 1 mL at a concentration of 5 mg/mL."

Placebo: normal saline, 0.5 mL per dose, IM.

Intranasal inoculation of S. Pneumoniae (80,000 CFU/100μl per nostril) serotype 6B.