Quality Control testing of bulk NOMV.

A) General characteristics include biochemical composition, PorA identity, and sterility for which preliminary specifications were set. B) Endotoxic activity of the bulk NOMV was approximately 25-fold lower than in DOMV and DTP-IPV reference vaccines. C) In addition, high bactericidal titres were induced in mice (2log titres >4 for 8 out of 9 PorA subtypes), with few non-responders. These results indicate that the bulk NOMV have a consistent product quality and are likely to be safe and immunogenic in humans. *During processing PorA concentration of bulk NOMV is set at 1 mg/mL for storage purposes. **Mean titre of responders.