よむ、つかう、まなぶ。
参考資料13 Vaccines and Related Biological Products Advisory Committee June 7, 2022 Meeting Presentation - FDA Review of Effectiveness and Safety of Novavax COVID-19 Vaccine in Adults > 18 Years of Age - Emergency Use Authorization Request（Vaccines and Related Biological Products Advisory Committee June 7, 2022 Meeting FDA提出資料） (13 ページ)
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| 出典情報 | 第80回厚生科学審議会予防接種・ワクチン分科会副反応検討部会、令和4年度第5回薬事・食品衛生審議会薬事分科会医薬品等安全対策部会安全対策調査会（合同開催）（6／10）《厚生労働省》 |
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301: Efficacy Analysis Populations
Population
NVX-CoV2373
n (%)
Placebo
n (%)
Total
n (%)
ITT
19963
9982
29945
PP-EFF
17272 (87.6)
8385 (85.0)
25657 (86.7)
Excluded from PP-EFF
Baseline positive anti-NP result
PP-EFF-2
Excluded from PP-EFF-2
2442 (12.4)
1483 (15.0)
3925 (13.3)
1100 (5.6)
622 (6.3)
1722 (5.8)
18438 (93.5)
9035 (91.6)
27473 (92.9)
1276 (6.5)
833 (8.4)
2109 (7.1)
Intention to Treat (ITT) Set: All participants randomized into the study
Per-protocol efficacy (PP-EFF): All participants who received the full prescribed regimen of study vaccine/ placebo, had no major protocol deviations prior to first COVID19 positive episode or administrative censoring, with no confirmed infection or prior infection due to SARS-CoV-2 at baseline and not censored prior to the start of the
observation period
PP-EFF-2: includes participants in the PP-EFF regardless of baseline SARS-CoV-2 status as determined by PCR
12
Population
NVX-CoV2373
n (%)
Placebo
n (%)
Total
n (%)
ITT
19963
9982
29945
PP-EFF
17272 (87.6)
8385 (85.0)
25657 (86.7)
Excluded from PP-EFF
Baseline positive anti-NP result
PP-EFF-2
Excluded from PP-EFF-2
2442 (12.4)
1483 (15.0)
3925 (13.3)
1100 (5.6)
622 (6.3)
1722 (5.8)
18438 (93.5)
9035 (91.6)
27473 (92.9)
1276 (6.5)
833 (8.4)
2109 (7.1)
Intention to Treat (ITT) Set: All participants randomized into the study
Per-protocol efficacy (PP-EFF): All participants who received the full prescribed regimen of study vaccine/ placebo, had no major protocol deviations prior to first COVID19 positive episode or administrative censoring, with no confirmed infection or prior infection due to SARS-CoV-2 at baseline and not censored prior to the start of the
observation period
PP-EFF-2: includes participants in the PP-EFF regardless of baseline SARS-CoV-2 status as determined by PCR
12