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File Name Date Produced File Size Link FDA-CBER-2021-5683-0123168-to-0126026_125742_S1_M5_c4591001-A-D-adva.zip (.xpt) May 2, 2022 7 MB FDA-CBER-2021-5683-0066701-to-0123167_125742_S1_M5_c4591001-A-D-adfacevd.zip (.xpt) May 2, 2022 81 MB FDA-CBER-2021-5683-0059000 to -0065773_125742_S1_M5_c4591001-A-D-adcevd.zip (.xpt) May 2, 2022 9 MB FDA CBER 2021 5683 0065774 to 0066700_125742_S1_M5_c4591001 A D addv.xpt May 2, 2022 44 MB FDA CBER 2021 5683 0058955 to 0058999_125742_S1_M5_bnt162 01 S define 2 0 0.xsl May 2, 2022 183 KB FDA CBER 2021 5683 0058795 to 0058828_125742_S1_M5_bnt162 01 A define 2 0 0.xsl May 2, 2022 183 KB FDA CBER 2021 5683 0058829 to 0058954_125742_S1_M5_bnt162 01 S define.xml May 2, 2022 985 KB FDA CBER 2021 5683 0058615 to 0058652_125742_S1_M5_c4591001 S Supp define.xml May 2, 2022 300 KB FDA CBER 2021 5683 0058653 to 0058675_125742_S1_M5_c4591001 S Supp define 2 0 0.xsl May 2, 2022 183 KB FDA CBER 2021 5683 0058676 to 0058794_125742_S1_M5_bnt162 01 A define.xsl May 2, 2022 828 KB FDA CBER 2021 5683 0058595 to 0058614_125742_S1_M5_c4591001 S define 2 0 0.xsl May 2, 2022 183 KB FDA CBER 2021 5683 0058459 to 0058478_125742_S1_M5_c4591001 A Supp define 2 0 0.xsl May 2, 2022 183 KB FDA CBER 2021 5683 0058479 to 0058594_125742_S1_M5_c4591001 S define.xml May 2, 2022 904 KB FDA CBER 2021 5683 0058316 to 0058458_125742_S1_M5_c4591001 A Supp define.xml May 2, 2022 692 KB 125742_S1_M5_CRF_c4591001 1006 10061098.pdf May 2, 2022 2 MB 125742_S1_M5_CRF_c4591001 1006 10061176.pdf May 2, 2022 3 MB 125742_S1_M5_CRF_c4591001 1006 10061094.pdf May 2, 2022 2 MB 125742_S1_M5_CRF_c4591001 1006 10061040.pdf May 2, 2022 4 MB 125742_S1_M5_CRF_c4591001 1006 10061052.pdf May 2, 2022 2 MB 125742_S1_M5_CRF_c4591001 1006 10061020.pdf May 2, 2022 2 MB 125742_S1_M5_CRF_c4591001 1005 10051411.pdf May 2, 2022 1 MB 125742_S1_M5_CRF_c4591001 1005 10051387.pdf May 2, 2022 2 MB 125742_S1_M5_CRF_c4591001 1005 10051293.pdf May 2, 2022 2 MB 125742_S1_M5_CRF_c4591001 1005 10051347.pdf May 2, 2022 1 MB 125742_S1_M5_CRF_c4591001 1005 10051214.pdf May 2, 2022 1 MB 125742_S1_M5_CRF_c4591001 1005 10051054.pdf May 2, 2022 2 MB 125742_S1_M5_CRF_c4591001 1005 10051069.pdf May 2, 2022 1 MB 125742_S1_M5_CRF_c4591001 1003 10031038.pdf May 2, 2022 3 MB 125742_S1_M5_CRF_c4591001 1001 10011100.pdf May 2, 2022 2 MB 125742_S1_M5_CRF_c4591001 1001 10011135.pdf May 2, 2022 1 MB 125742_S1_M5_CRF_c4591001 1001 10011093.pdf May 2, 2022 3 MB 125742_S1_M5_CRF_c4591001 1005 10051047.pdf May 2, 2022 1 MB 125742_S1_M5_CRF_c4591001 1003 10031197.pdf May 2, 2022 1 MB 125742_S1_M5_CRF_c4591001 1003 10031207.pdf May 2, 2022 1 MB 125742_S1_M5_CRF_c4591001 1003 10031186.pdf May 2, 2022 2 MB 125742_S1_M5_CRF_c4591001 1003 10031149.pdf May 2, 2022 2 MB 125742_S1_M5_CRF_c4591001 1003 10031113.pdf May 2, 2022 3 MB 125742_S1_M5_CRF_c4591001 1003 10031111.pdf May 2, 2022 2 MB 125742_S1_M5_CRF_c4591001 1003 10031065.pdf May 2, 2022 3 MB 125742_S1_M5_bnt162 01 S acrf.pdf May 2, 2022 1 MB 125742_S1_M5_bnt162 01 A adrg.pdf May 2, 2022 891 KB 125742_S1_M5_c4591001 S csdrg.pdf May 2, 2022 1 MB 125742_S1_M5_c4591001 S Supp acrf.pdf May 2, 2022 3 MB 125742_S1_M5_c4591001 S acrf.pdf May 2, 2022 3 MB 125742_S1_M5_bnt162 01 S csdrg.pdf May 2, 2022 1 MB 125742_S1_M5_5351_c4591001 interim mth6 sponsor signature.pdf May 2, 2022 12 MB 125742_S1_M5_5351_c4591001 interim mth6 sample crf.pdf May 2, 2022 5 MB 125742_S1_M5_5351_c4591001 interim mth6 randomization sensitive.pdf May 2, 2022 65 MB 125742_S1_M5_5351_bnt162 01 interim3 sample crf.pdf May 2, 2022 9 MB 125742_S1_M5_5351_bnt162 01 interim3 report body.pdf May 2, 2022 42 MB 125742_S1_M5_5351_bnt162 01 interim3 protocol deviations.pdf May 2, 2022 1 MB 125742_S1_M5_5351_bnt162 01 interim3 protocol.pdf May 2, 2022 10 MB 125742_S1_M5_5351_bnt162 01 interim3 patient batches.pdf May 2, 2022 3 MB 125742_S1_M5_5351_bnt162 01 interim3 notes for reader.pdf May 2, 2022 1 MB 125742_S1_M5_5351_bnt162 01 interim3 synopsis.pdf May 2, 2022 4 MB 125742_S1_M5_5351_bnt162 01 interim3 sponsor signature.pdf May 2, 2022 2 MB 125742_S1_M5_5351_bnt162 01 interim3 sponsor personnel list.pdf May 2, 2022 2 MB 125742_S1_M5_5351_bnt162 01 interim3 sap.pdf May 2, 2022 3 MB 125742_S1_M5_5351_bnt162 01 interim3 lab measurements.pdf May 2, 2022 91 MB 125742_S1_M5_5351_bnt162 01 interim3 discontinued patients.pdf May 2, 2022 2 MB 125742_S1_M5_5351_bnt162 01 interim3 demographics.pdf May 2, 2022 2 MB 125742_S1_M5_5351_bnt162 01 interim3 compliance.pdf May 2, 2022 7 MB 125742_S1_M5_5351_bnt162 01 interim3 adverse events.pdf May 2, 2022 7 MB 125742_S1_M5_5351_bnt162 01 interim3 investigators.pdf May 2, 2022 6 MB 125742_S1_M5_5351_bnt162 01 interim3 invest signature.pdf May 2, 2022 634 KB 125742_S1_M5_5351_bnt162 01 interim3 iec irb.pdf May 2, 2022 1 MB 125742_S1_M5_5351_bnt162 01 interim3 excluded patients.pdf May 2, 2022 2 MB 125742_S1_M5_5351_bnt162 01_10075.pdf May 2, 2022 2 MB 125742_S1_M5_5351_bnt162 01_10010.pdf May 2, 2022 1 MB 125742_S1_M5_5351_bnt162 01_20215.pdf May 2, 2022 2 MB 125742_S1_M5_5351_bnt162 01_20242.pdf May 2, 2022 2 MB 125742_S1_M5_5351_bnt162 01_20116.pdf May 2, 2022 2 MB 125742_S1_M5_5351_c4591001-fa-interim-protocol-deviations.pdf April 1, 2022 1 MB 125742_S1_M5_5351_c4591001-fa-interim-iec-irb-consent-form.pdf April 1, 2022 8 MB 125742_S1_M5_5351_c4591001-fa-interim-invest-signature.pdf April 1, 2022 677 KB 125742_S1_M5_5351_c4591001-fa-interim-demographics.pdf April 1, 2022 28 MB 125742_S1_M5_5351_c4591001-fa-interim-audit-certificates.pdf April 1, 2022 869 KB 125742_S1_M5_5351_c4591001-interim-mth6-invest-signature.pdf April 1, 2022 1 MB reissue_5.3.6 postmarketing experience.pdf April 1, 2022 958 KB 125742_S1_M5_5351_c4591001-interim-mth6-demographics.pdf April 1, 2022 28 MB 125742_S1_M5_5351_c4591001-interim-mth6-audit-certificates.pdf April 1, 2022 1 MB 125742_S1_M5_5351_c4591001-fa-interim-sponsor-signature.pdf April 1, 2022 2 MB 125742_S1_M5_5351_c4591001-interim-mth6-adverse-events-sensitive.pdf April 1, 2022 1 MB 125742_S1_M5_5351_c4591001-fa-interim-sample-crf.pdf April 1, 2022 5 MB 125742_S1_M5_5351_c4591001-fa-interim-randomization-sensitive.pdf April 1, 2022 59 MB 125742_S1_M5_5351_c4591001-fa-interim-randomization.pdf April 1, 2022 2 MB 125742_S1_M5_5351_c4591001-fa-interim-publications.pdf April 1, 2022 10 MB 125742_S1_M1_priority-review-request.pdf March 24, 2022 2 MB FDA-CBER-2021-5683-0023924_125742_S1_M5_c4591001-A-report-cci-chf.xlsx March 1, 2022 10 KB FDA-CBER-2021-5683-0023926_125742_S1_M5_c4591001-A-report-cci-dementia.xlsx March 1, 2022 9 KB FDA-CBER-2021-5683-0023878_125742_S1_M5_c4591001-A-report-cci-aids-hiv.xlsx March 1, 2022 23 KB FDA-CBER-2021-5683-0023895 to -0023915_125742_S1_M5_c4591001-A-report-cci-any-malignancy.xlsx March 1, 2022 35 KB FDA-CBER-2021-5683-0023919 to -0023921_125742_S1_M5_c4591001-A-report-cci-cerebrovascular.xlsx March 1, 2022 12 KB FDA-CBER-2021-5683-0023550 to -0023569_125742_S1_M5_c4591001-A-first-c4591001-360-participants-enrolled-v1-13aug20-update.xlsx March 1, 2022 22 KB FDA-CBER-2021-5683-0023711 to -0023875_125742_S1_M5_c4591001-A-newlist-c4591001-6k-participants-enrolled-v3-17sep2020.xlsx March 1, 2022 84 KB FDA-CBER-2021-5683-0023500 to -0023507_125742_S1_M5_c4591001-A-c4591001-phase-1-subjects-from-dmw.xlsx March 1, 2022 29 KB FDA-CBER-2021-5683-0023523 to -0023538_125742_S1_M5_c4591001-A-c4591001-subject-list-for-12-25-immuno-analysis-27jan2021.xlsx March 1, 2022 18 KB FDA-CBER-2021-5683-0023540_125742_S1_M5_c4591001-A-comorbidity-categories.xlsx March 1, 2022 19 KB FDA-CBER-2021-5683-0023979 to -0023980_125742_S1_M5_c4591001-A-report-cci-renal.xlsx March 1, 2022 11 KB FDA-CBER-2021-5683-0023983 to -0023984_125742_S1_M5_c4591001-A-report-cci-rheumatic.xlsx March 1, 2022 24 KB FDA-CBER-2021-5683-0023987_125742_S1_M5_c4591001-A-201114-hiv-preferred-terms.xlsx March 1, 2022 21 KB FDA-CBER-2021-5683-0023971 to -0023972_125742_S1_M5_c4591001-A-report-cci-periph-vasc.xlsx March 1, 2022 12 KB FDA-CBER-2021-5683-0023975 to -0023976_125742_S1_M5_c4591001-A-report-cci-pulmonary.xlsx March 1, 2022 12 KB FDA-CBER-2021-5683-0023963_125742_S1_M5_c4591001-A-report-cci-mild-liver.xlsx March 1, 2022 10 KB FDA-CBER-2021-5683-0023965_125742_S1_M5_c4591001-A-report-cci-mod-sev-liver.xlsx March 1, 2022 9 KB FDA-CBER-2021-5683-0023967_125742_S1_M5_c4591001-A-report-cci-peptic-ulcer.xlsx March 1, 2022 9 KB FDA-CBER-2021-5683-0023955 to -0023958_125742_S1_M5_c4591001-A-report-cci-metastatic-tumour.xlsx March 1, 2022 14 KB FDA-CBER-2021-5683-0023960_125742_S1_M5_c4591001-A-report-cci-mi.xlsx March 1, 2022 9 KB FDA-CBER-2021-5683-0023932_125742_S1_M5_c4591001-A-report-cci-hemiplegia.xlsx March 1, 2022 10 KB FDA-CBER-2021-5683-0023936 to -0023937_125742_S1_M5_c4591001-A-report-cci-leukemia.xlsx March 1, 2022 12 KB FDA-CBER-2021-5683-0023944 to -0023950_125742_S1_M5_c4591001-A-report-cci-lymphoma.xlsx March 1, 2022 17 KB FDA-CBER-2021-5683-0023928_125742_S1_M5_c4591001-A-report-cci-diabetes-with-comp.xlsx March 1, 2022 9 KB FDA-CBER-2021-5683-0023930_125742_S1_M5_c4591001-A-report-cci-diabetes-without-comp.xlsx March 1, 2022 10 KB FDA-CBER-2021-5683-0023455 to -0023486_125742_S1_M5_c4591001-A-define-2-0-0.xsl March 1, 2022 183 KB FDA-CBER-2021-5683-0023490 to -0023491_125742_S1_M5_c4591001-A-bmi-12-15-scale.xlsx March 1, 2022 13 KB FDA-CBER-2021-5683-0023490 to -0023491_125742_S1_M5_c4591001-A-bmi-12-15-scale.xlsx March 1, 2022 13 KB FDA-CBER-2021-5683-0022618 to -0022691_125742_S1_M5_c4591001-A-P-adsl-demo-7d-eval-eff-sas.txt March 1, 2022 75 KB FDA-CBER-2021-5683-0023007 to -0023031_125742_S1_M5_c4591001-A-P-adsympt-sas.txt March 1, 2022 43 KB FDA-CBER-2021-5683-0023032 to -0023065_125742_S1_M5_c4591001-A-P-adva-sas.txt March 1, 2022 45 KB FDA-CBER-2021-5683-0022793 to -0022866_125742_S1_M5_c4591001-A-P-adsl-s005-demo-all-p3-saf-sas.txt March 1, 2022 75 KB FDA-CBER-2021-5683-0022867 to -0023006_125742_S1_M5_c4591001-A-P-adsl-sas.txt March 1, 2022 197 KB FDA-CBER-2021-5683-0022692 to -0022765_125742_S1_M5_c4591001-A-P-adsl-demo-7d-wwo-eval-eff-sas.txt March 1, 2022 75 KB FDA-CBER-2021-5683-0022766 to -0022792_125742_S1_M5_c4591001-A-P-adsl-fu-d2-p3-saf-sas.txt March 1, 2022 29 KB FDA-CBER-2021-5683-0022326 to -0022345_125742_S1_M5_c4591001-A-P-adcevd-sas.txt March 1, 2022 27 KB FDA-CBER-2021-5683-0022063 to -0022135_125742_S1_M5_c4591001-A-P-adce-s010-lr-p3-saf-sas.txt March 1, 2022 72 KB FDA-CBER-2021-5683-0022136 to -0022325_125742_S1_M5_c4591001-A-P-adce-s020-se-p3-saf-sas.txt March 1, 2022 193 KB FDA-CBER-2021-5683-0022601 to -0022617_125742_S1_M5_c4591001-A-P-admh-sas.txt March 1, 2022 24 KB FDA-CBER-2021-5683-0022041 to -0022053_125742_S1_M5_c4591001-A-P-adc19ef-ve-cov-7pd2-wo-sg-eval-sas.txt March 1, 2022 19 KB FDA-CBER-2021-5683-0022054 to -0022062_125742_S1_M5_c4591001-A-P-adc19ef-ve-sev-cov-pd1-aai-sas.txt March 1, 2022 12 KB FDA-CBER-2021-5683-0022561 to -0022567_125742_S1_M5_c4591001-A-P-adds-sas.txt March 1, 2022 11 KB FDA-CBER-2021-5683-0022568 to -0022600_125742_S1_M5_c4591001-A-P-adfacevd-sas.txt March 1, 2022 49 KB FDA-CBER-2021-5683-0022346 to -0022364_125742_S1_M5_c4591001-A-P-adcm-sas.txt March 1, 2022 32 KB FDA-CBER-2021-5683-0022365 to -0022560_125742_S1_M5_c4591001-A-P-adds-s002-all-p3-rand-sas.txt March 1, 2022 156 KB 125742_S1_M5_CRF_c4591001-1085-10851216 March 1, 2022 1 MB FDA-CBER-2021-5683-0021981 to -0022027_125742_S1_M5_c4591001-A-P-adc19ef-sas March 1, 2022 81 KB FDA-CBER-2021-5683-0022028 to -0022040_125742_S1_M5_c4591001-A-P-adc19ef-ve-cov-7pd2-sg-eval-sas March 1, 2022 20 KB FDA-CBER-2021-5683-0021930 to -0021943_125742_S1_M5_c4591001-A-P-adae-s092-cr-cut-p3x-saf-sas March 1, 2022 15 KB FDA-CBER-2021-5683-0021944 to -0021963_125742_S1_M5_c4591001-A-P-adae-sas March 1, 2022 35 KB FDA-CBER-2021-5683-0021964 to -0021980_125742_S1_M5_c4591001-A-P-adae-vax-tier2-p3-saf-sas March 1, 2022 18 KB FDA-CBER-2021-5683-0021902 to -0021915_125742_S1_M5_c4591001-A-P-adae-s091-all-pd2-p3-saf2-sas March 1, 2022 15 KB FDA-CBER-2021-5683-0021916 to -0021929_125742_S1_M5_c4591001-A-P-adae-s092-all-unb-p3-saf-sas March 1, 2022 15 KB 125742_S1_M5_CRF_c4591001-1085-10851246.pdf March 1, 2022 1 MB FDA-CBER-2021-5683-0021888 to -0021901_125742_S1_M5_c4591001-A-P-adae-s091-all-pd2-p3-saf1-sas.txt March 1, 2022 14 KB 125742_S1_M5_c4591001-T-S-roadmap.pdf March 1, 2022 703 KB 125742_S1_M5_c4591001-T-S-final-reacto-tables-track.pdf March 1, 2022 2 MB 125742_S1_M5_c4591001-A-report-cci-renal.pdf March 1, 2022 629 KB 125742_S1_M5_c4591001-A-report-cci-rheumatic.pdf March 1, 2022 629 KB 125742_S1_M5_CRF_c4591001-1085-10851129.pdf March 1, 2022 2 MB 125742_S1_M5_CRF_c4591001-1085-10851018.pdf March 1, 2022 2 MB 125742_S1_M5_CRF_c4591001-1085-10851116.pdf March 1, 2022 1 MB 125742_S1_M5_c4591001-T-S-updated-reacto-tlf.pdf March 1, 2022 17 MB 125742_S1_M5_c4591001-T-S-suppl-arg.pdf March 1, 2022 738 KB 125742_S1_M5_c4591001-T-S-summary-differences-csr-vs-update.pdf March 1, 2022 667 KB 125742_S1_M5_c4591001-A-report-cci-lymphoma.pdf March 1, 2022 640 KB 125742_S1_M5_c4591001-A-report-cci-hemiplegia.pdf March 1, 2022 626 KB 125742_S1_M5_c4591001-A-report-cci-leukemia.pdf March 1, 2022 631 KB 125742_S1_M5_c4591001-A-report-cci-periph-vasc.pdf March 1, 2022 632 KB 125742_S1_M5_c4591001-A-report-cci-pulmonary.pdf March 1, 2022 630 KB 125742_S1_M5_c4591001-A-report-cci-peptic-ulcer.pdf March 1, 2022 625 KB 125742_S1_M5_c4591001-A-report-cci-mild-liver.pdf March 1, 2022 628 KB 125742_S1_M5_c4591001-A-report-cci-mod-sev-liver.pdf March 1, 2022 626 KB 125742_S1_M5_c4591001-A-report-cci-metastatic-tumour.pdf March 1, 2022 636 KB 125742_S1_M5_c4591001-A-report-cci-mi.pdf March 1, 2022 624 KB 125742_S1_M5_c4591001-A-report-cci-any-malignancy.pdf March 1, 2022 670 KB 125742_S1_M5_c4591001-A-newlist-c4591001-6k-participants-enrolled-v3-17sep2020.pdf March 1, 2022 846 KB 125742_S1_M5_c4591001-A-report-cci-aids-hiv.pdf March 1, 2022 629 KB 125742_S1_M5_c4591001-A-first-c4591001-360-participants-enrolled-v1-13aug20-update.pdf March 1, 2022 607 KB 125742_S1_M5_c4591001-A-report-cci-diabetes-without-comp.pdf March 1, 2022 627 KB 125742_S1_M5_c4591001-A-comorbidity-categories.pdf March 1, 2022 637 KB 125742_S1_M5_c4591001-A-report-cci-diabetes-with-comp.pdf March 1, 2022 626 KB 125742_S1_M5_c4591001-A-report-cci-chf.pdf March 1, 2022 628 KB 125742_S1_M5_c4591001-A-report-cci-dementia.pdf March 1, 2022 626 KB 125742_S1_M5_c4591001-A-report-cci-cerebrovascular.pdf March 1, 2022 632 KB 125742_S1_M5_5351_c4591001-fa-interim-oversight-committees.pdf March 1, 2022 2 MB 125742_S1_M5_5351_c4591001-fa-interim-lab-measurements-sensitive.pdf March 1, 2022 5 MB 125742_S1_M5_c4591001-A-c4591001-subject-list-for-12-25-immuno-analysis-27jan2021.pdf March 1, 2022 620 KB 125742_S1_M5_c4591001-A-c4591001-phase-1-subjects-from-dmw.pdf March 1, 2022 634 KB 125742_S1_M5_c4591001-A-adrg.pdf March 1, 2022 2 MB 125742_S1_M5_c4591001-A-bmi-12-15-scale.pdf March 1, 2022 627 KB 125742_S1_M5_5351_c4591001-interim-mth6-protocol.pdf March 1, 2022 37 MB 125742_S1_M5_c4591001-A-201114-hiv-preferred-terms.pdf March 1, 2022 602 KB 125742_S1_M5_5351_c4591001-interim-mth6-oversight-committees.pdf March 1, 2022 13 MB 125742_S1_M5_5351_c4591001-fa-interim-protocol.pdf March 1, 2022 31 MB 125742_S1_M5_5351_c4591001-fa-interim-excluded-patients.pdf March 1, 2022 2 MB 125742_S1_M5_5351_c4591001-fa-interim-errata.pdf March 1, 2022 2 MB 125742_S1_M5_5351_c4591001-fa-interim-efficacy-response.pdf March 1, 2022 2 MB 125742_S1_M5_5351_c4591001-fa-interim-compliance-sensitive.pdf March 1, 2022 1 MB 125742_S1_M5_5351_c4591001-ad-hoc-label-tables.pdf March 1, 2022 889 KB 125742_S1_M5_5351_c4591001-fa-interim-compliance.pdf March 1, 2022 2 MB 125742_S1_M4_4223_R-20-0072.pdf March 1, 2022 5 MB 125742_S1_M4_4223_185350.pdf March 1, 2022 1 MB 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