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03資料１－１ 新型コロナワクチンの接種について (39 ページ)
出典
| 公開元URL | https://www.mhlw.go.jp/stf/newpage_75806.html |
| 出典情報 | 厚生科学審議会 予防接種・ワクチン分科会（第67回 9／2）《厚生労働省》 |
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LP.8.1 Study Designs & Primary Objectives
Two Phase 3b/4, open-label, single arm studies
(mRNA-1283
P401: Part A)
Participants
≥ 12 years
mRNA-1283 - 10 µg
N = ~172
mRNA-1283.251 (LP.8.1 variant)
mRNA-283:
mNEXSPIKE
mRNA-283: mNEXSPIKE
mRNA-1273 - 50 µg
(mRNA-1273
P403: Part A)
N = ~104
mRNA-1273.251 (LP.8.1 variant)
mRNA-1273: SPIKEVAX
Stratification:
Age groups
(12-64*, ≥65)
* ≥1 risk factor for severe
outcomes from COVID-19
mRNA-1273: SPIKEVAX
Primary: Immunogenicity against vaccine-matched variant
LP.8.1 NAb and fold-rise at Day 29
•
Secondary: adverse events, serious adverse events for the duration of the study
Exploratory Assessment: Immunogenicity against new variants
•
•
nAb against circulating variants (XFG, BA.3.2.2) D29
fit-for-purpose assay (results above ULOQ not capped at ULOQ, Results below LOD imputed as 0.5*LOD).
Primary
Endpoint
Exploratory
https://clinicaltrials.gov/study/ NCT06585241
https://clinicaltrials.gov/study/NCT07089706
© 2026 Moderna, Inc. All rights reserved.
39
LP.8.1 Study Designs & Primary Objectives
Two Phase 3b/4, open-label, single arm studies
(mRNA-1283
P401: Part A)
Participants
≥ 12 years
mRNA-1283 - 10 µg
N = ~172
mRNA-1283.251 (LP.8.1 variant)
mRNA-283:
mNEXSPIKE
mRNA-283: mNEXSPIKE
mRNA-1273 - 50 µg
(mRNA-1273
P403: Part A)
N = ~104
mRNA-1273.251 (LP.8.1 variant)
mRNA-1273: SPIKEVAX
Stratification:
Age groups
(12-64*, ≥65)
* ≥1 risk factor for severe
outcomes from COVID-19
mRNA-1273: SPIKEVAX
Primary: Immunogenicity against vaccine-matched variant
LP.8.1 NAb and fold-rise at Day 29
•
Secondary: adverse events, serious adverse events for the duration of the study
Exploratory Assessment: Immunogenicity against new variants
•
•
nAb against circulating variants (XFG, BA.3.2.2) D29
fit-for-purpose assay (results above ULOQ not capped at ULOQ, Results below LOD imputed as 0.5*LOD).
Primary
Endpoint
Exploratory
https://clinicaltrials.gov/study/ NCT06585241
https://clinicaltrials.gov/study/NCT07089706
© 2026 Moderna, Inc. All rights reserved.
39