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） (5 ページ)
出典
| 公開元URL | https://www.mhlw.go.jp/stf/shingi2/0000208910_00043.html |
| 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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Overview of Clinical Studies
Study Number/
Country
Study 301
USA,
Mexico
Description
NVX recipients in
pre-crossover
safety population
Study Status
Phase 3, randomized, observer-blinded, placebo-controlled efficacy,
safety, immunogenicity study
19735
Ongoing
Additional Safety Data
Study 302
United Kingdom
Phase 3, multicenter, randomized, observer-blinded, placebo-controlled
study in adults 18-84 years of age
7569
Ongoing
Study 501
South Africa
Phase 2, randomized, observer-blinded, placebo-controlled study in healthy
HIV-negative adults 18-84 years of age and HIV-positive adults 18-64 years
of age
2211
Ongoing
Study 101, Part 1
Australia
Phase 1, randomized, observer-blinded, placebo-controlled in adults 18-59
years of age
29
Completed
Study 101, Part 2
Australia/USA
Phase 2, randomized, observer-blinded, placebo-controlled in adults 1884 years of age
513
Ongoing
4
Study Number/
Country
Study 301
USA,
Mexico
Description
NVX recipients in
pre-crossover
safety population
Study Status
Phase 3, randomized, observer-blinded, placebo-controlled efficacy,
safety, immunogenicity study
19735
Ongoing
Additional Safety Data
Study 302
United Kingdom
Phase 3, multicenter, randomized, observer-blinded, placebo-controlled
study in adults 18-84 years of age
7569
Ongoing
Study 501
South Africa
Phase 2, randomized, observer-blinded, placebo-controlled study in healthy
HIV-negative adults 18-84 years of age and HIV-positive adults 18-64 years
of age
2211
Ongoing
Study 101, Part 1
Australia
Phase 1, randomized, observer-blinded, placebo-controlled in adults 18-59
years of age
29
Completed
Study 101, Part 2
Australia/USA
Phase 2, randomized, observer-blinded, placebo-controlled in adults 1884 years of age
513
Ongoing
4