VaccinesandRelatedBiologicalProductsAdvisory.pptVIP

VRBPAC: HEPLISAV BACK-UP SLIDES * Comparison of SPRs: Pooled mITT for DV2-HBV-10 and 16, compared with Engerix-Bb, TWINRIXb and HAVRIX/Engerix-BbSPR at Weeks 4, 8, and 28 for HEPLISAV compared with Engerix-B: Visit HEPLISAVc SPR (%) Engerix-Bc SPR (%) Engerix-Bd (Label) SPR (%) TWINRIXd (Label) SPR (%) HAVRIX and Engerix-Bd (Label) SPR (%) Week 4 21.8% 4.2% NA 17.9% 7.5% Week 8 81.4 % 23.8 % NA 61.2% 50.4% Week 28 96.2% 76.7% 96.0% 95.1% 92.2% CI: Confidence Interval, NA: Not available in the label. a Estimated response (proportion), their difference, and associated confidence inter