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04資料1-2 森野委員提出資料（成人用肺炎球菌ワクチンファクトシート追補版） (32 ページ)
出典
| 公開元URL | https://www.mhlw.go.jp/stf/newpage_76211.html |
| 出典情報 | 厚生科学審議会 予防接種・ワクチン分科会 予防接種基本方針部会 ワクチン評価に関する小委員会（第36回 9／17）《厚生労働省》 |
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31.
MSD 株式会社. キャップバックス筋注シリンジ添付文書. 2025.
https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/170050_631140NG1024_1_02
(accessed 2026/7/31).
32.
森野紗衣子, 高梨さやか, 北村則子, 鈴木基, 常彬, 明田幸宏. 肺炎球菌ワクチンの国内導入経過
（2025 年 12 月現在）. 病原微生物検出情報 (IASR) 2026; (２): 4–6.
33.
Avci FY, Li X, Tsuji M, Kasper DL. A mechanism for glycoconjugate vaccine activation of the
adaptive immune system and its implications for vaccine design. Nat Med 2011; 17(12): 1602–9.
34.
医薬品医療機器総合機構. キャップバックス筋注シリンジ審査報告書. 2025/7/31.
https://www.pmda.go.jp/drugs/2025/P20250828001/170050000_30700AMX00129_A100_1.pdf (accessed
2026/7/31).
35.
Platt HL, Bruno C, Buntinx E, et al. Safety, tolerability, and immunogenicity of an adult
pneumococcal conjugate vaccine, V116 (STRIDE-3): a randomised, double-blind, active comparator
controlled, international phase 3 trial. Lancet Infect Dis 2024; 24(10): 1141–50.
36.
Kishino H, Inoue S, Matsuoka O, et al. A phase 3 randomized trial (STRIDE-9) to evaluate the safety,
tolerability, and immunogenicity of V116, a population-specific pneumococcal conjugate vaccine, in
pneumococcal vaccine-naïve Japanese adults ≥65 years of age. Vaccine 2025; 62: 127456.
37.
Scott P, Ukkonen B, Caraco Y, et al. A phase 3, randomized trial to evaluate lot-to-lot consistency of
V116, an adult-specific pneumococcal conjugate vaccine (STRIDE-4). Med 2025; 6(10): 100748.
38.
Scott P, Haranaka M, Choi JH, et al. A Phase 3 Clinical Study to Evaluate the Safety, Tolerability, and
Immunogenicity of V116 in Pneumococcal Vaccine-Experienced Adults 50 Years of Age or Older (STRIDE-6).
Clin Infect Dis 2024; 79(6): 1366–74.
39.
Scott PT, Pathirana J, Kato A, et al. A Phase 3, Randomized Trial Investigating the Safety,
Tolerability, and Immunogenicity of V116, an Adult-Specific Pneumococcal Conjugate Vaccine, in
Pneumococcal Vaccine-Naïve Adults 18-64 Years of Age at Increased Risk of Pneumococcal Disease, STRIDE8. Clin Infect Dis 2026; 82(2): e217–e26.
40.
Pathirana J, Ramgopal M, Martin C, et al. Safety, tolerability, and immunogenicity of an adult-specific
pneumococcal conjugate vaccine, V116, in people living with HIV (STRIDE-7): a two-part, parallel-group,
randomised, active comparator-controlled, international, phase 3 trial. Lancet HIV 2025; 12(10): e679–e90.
41.
Omole T, Weinberg AS, Azizad M, et al. A phase 3 randomized, double-blind clinical study to
evaluate the safety and immunogenicity of V116 when administered concomitantly with influenza vaccine in
adults 50 years of age or older. Vaccine 2025; 62: 127514.
42.
Romero-Steiner S, Frasch CE, Carlone G, Fleck RA, Goldblatt D, Nahm MH. Use of
opsonophagocytosis for serological evaluation of pneumococcal vaccines. Clin Vaccine Immunol 2006; 13(2):
165–9.
43.
van Werkhoven CH, Huijts SM, Bolkenbaas M, Grobbee DE, Bonten MJ. The Impact of Age on the
Efficacy of 13-valent Pneumococcal Conjugate Vaccine in Elderly. Clin Infect Dis 2015; 61(12): 1835–8.
44.
Suaya JA, Jiang Q, Scott DA, et al. Post hoc analysis of the efficacy of the 13-valent pneumococcal
conjugate vaccine against vaccine-type community-acquired pneumonia in at-risk older adults. Vaccine 2018;
32
MSD 株式会社. キャップバックス筋注シリンジ添付文書. 2025.
https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/170050_631140NG1024_1_02
(accessed 2026/7/31).
32.
森野紗衣子, 高梨さやか, 北村則子, 鈴木基, 常彬, 明田幸宏. 肺炎球菌ワクチンの国内導入経過
（2025 年 12 月現在）. 病原微生物検出情報 (IASR) 2026; (２): 4–6.
33.
Avci FY, Li X, Tsuji M, Kasper DL. A mechanism for glycoconjugate vaccine activation of the
adaptive immune system and its implications for vaccine design. Nat Med 2011; 17(12): 1602–9.
34.
医薬品医療機器総合機構. キャップバックス筋注シリンジ審査報告書. 2025/7/31.
https://www.pmda.go.jp/drugs/2025/P20250828001/170050000_30700AMX00129_A100_1.pdf (accessed
2026/7/31).
35.
Platt HL, Bruno C, Buntinx E, et al. Safety, tolerability, and immunogenicity of an adult
pneumococcal conjugate vaccine, V116 (STRIDE-3): a randomised, double-blind, active comparator
controlled, international phase 3 trial. Lancet Infect Dis 2024; 24(10): 1141–50.
36.
Kishino H, Inoue S, Matsuoka O, et al. A phase 3 randomized trial (STRIDE-9) to evaluate the safety,
tolerability, and immunogenicity of V116, a population-specific pneumococcal conjugate vaccine, in
pneumococcal vaccine-naïve Japanese adults ≥65 years of age. Vaccine 2025; 62: 127456.
37.
Scott P, Ukkonen B, Caraco Y, et al. A phase 3, randomized trial to evaluate lot-to-lot consistency of
V116, an adult-specific pneumococcal conjugate vaccine (STRIDE-4). Med 2025; 6(10): 100748.
38.
Scott P, Haranaka M, Choi JH, et al. A Phase 3 Clinical Study to Evaluate the Safety, Tolerability, and
Immunogenicity of V116 in Pneumococcal Vaccine-Experienced Adults 50 Years of Age or Older (STRIDE-6).
Clin Infect Dis 2024; 79(6): 1366–74.
39.
Scott PT, Pathirana J, Kato A, et al. A Phase 3, Randomized Trial Investigating the Safety,
Tolerability, and Immunogenicity of V116, an Adult-Specific Pneumococcal Conjugate Vaccine, in
Pneumococcal Vaccine-Naïve Adults 18-64 Years of Age at Increased Risk of Pneumococcal Disease, STRIDE8. Clin Infect Dis 2026; 82(2): e217–e26.
40.
Pathirana J, Ramgopal M, Martin C, et al. Safety, tolerability, and immunogenicity of an adult-specific
pneumococcal conjugate vaccine, V116, in people living with HIV (STRIDE-7): a two-part, parallel-group,
randomised, active comparator-controlled, international, phase 3 trial. Lancet HIV 2025; 12(10): e679–e90.
41.
Omole T, Weinberg AS, Azizad M, et al. A phase 3 randomized, double-blind clinical study to
evaluate the safety and immunogenicity of V116 when administered concomitantly with influenza vaccine in
adults 50 years of age or older. Vaccine 2025; 62: 127514.
42.
Romero-Steiner S, Frasch CE, Carlone G, Fleck RA, Goldblatt D, Nahm MH. Use of
opsonophagocytosis for serological evaluation of pneumococcal vaccines. Clin Vaccine Immunol 2006; 13(2):
165–9.
43.
van Werkhoven CH, Huijts SM, Bolkenbaas M, Grobbee DE, Bonten MJ. The Impact of Age on the
Efficacy of 13-valent Pneumococcal Conjugate Vaccine in Elderly. Clin Infect Dis 2015; 61(12): 1835–8.
44.
Suaya JA, Jiang Q, Scott DA, et al. Post hoc analysis of the efficacy of the 13-valent pneumococcal
conjugate vaccine against vaccine-type community-acquired pneumonia in at-risk older adults. Vaccine 2018;
32