Advances in Preventive Medicine / 2012 / Article / Tab 1

Review Article

Advanced Development of the rF1V and rBV A/B Vaccines: Progress and Challenges

Table 1

Required performance parameters for the rBV A/B and rF1V vaccines.

Key Performance Parameter: FDA Licensure
Performance attribute Development threshold Development objective
rBV A/BrF1VrBV A/BrF1V

Efficacy Protect 80% of immunized persons Protect 90% of immunized persons

Immune response An immune response sufficient to meet threshold efficacy requirements for this vaccine within 210 days of the initial vaccine dose An immune response sufficient to meet threshold efficacy requirements for this vaccine within 30 days of the initial vaccine dose

Duration of protection Protection for at least one year from completion of the primary vaccination series Protection for five years after the administration of a single-dose vaccine
Number of doses to achieve protection (primary series)31

Shelf life1 year5 years

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