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. 2019 Oct 9;12:3169–3188. doi: 10.2147/IDR.S159952

Table 3.

Key Clinical Trials On 4cmenb Vaccine

Findlow 201028 (UK) Snape 201073 (UK) Kimura 201169 (Italy And Germany) Gossger 201230 (Belgium, United Kingdom, Czech Republic, Germany, Italy, And Spain) Vesikari 201371 (Finland, Czech Republic, Germany, Austria And Italy)

  1. Study Characteristics

Study Design Phase II Phase II Phase II Phase II2B Phase III
Study subjects and age Infants
(2 months)		 Infants
(6–8 months)		 Adults
(18–50 years)		 Infants
(2 months)		 Infants
(2 months)
Schedule (3 dose regimen) 2, 4, 6, and 12 months of age Day 0, day 60, and 12 months of age Day 0, day 60, and 4 months 2, 4, and 6 months of age 2, 4, 6, and 12 months of age
Sample size (total) 147 60 54 1885 3630
(II) Immunogenicity endpoints (strain-specific)*

  1. Proportion of patients with hSBA titers >1:4

  1. 44/76-SL

  2. NZ98/254

  3. 5/99

  4. M01 240101

  5. M00 242922

  6. M01 240364

  7. M01 24035

 87% (34/39)
85% (34/40)
61% (35/57)
47% (18/38)
63% (24/38)
12% (4/33)
– (0/32)		 100% (24/24)
100% (24/24)
96% (23/24)
100% (22/22)
70% (16/23)
100% (2/2)
90% (18/20)		 97% (38/39)
100% (39/39)
92% (36/39)		 99% (521/525)**
79% (417/528)**
99% (517/520)**		 100% (1181/1181)
100% (1184/1184)
84% (992/1183)
(H) Geometric mean titers

  1. 44/76-SL

  2. NZ98/254

  3. 5/99

 30.0 (19.0–46.0)
126.0 (77.0–205.0)
19.0 (11.0–33.0)		 189 (136–263)
906 (700–1172)
44 (32–62)		 95 (68–131)
269 (205–354)
30 (18–50)		 83 (77–90)
12 (10–13)
520 (475–570)		 91 (88–95)
634 (606–664)

  1. 13–15)
(III) Safety Endpoints
Serious AEs (total) 18% (9/50) 3% (1/30) – (0/50) 10% (63/625) 8% (210/2480)
AEs (total) 100% (50/50) 100% (30/30) 100% (50/50) 99% (620/625) 99% (2469/2480)

  1. Pyrexia

  2. Tenderness

  3. Erythema

  4. Swelling

 23% (11/48)
75% (36/48)
98% (47/48)
75% (36/48)		 10% (6/30)
60% (18/30)
93% (28/30)
67% (20/30)		 – (0/50)
100% (50/50)
56% (28/50)-		 83% (514/624)
85% (529/624)
86% (535/625)
53% (328/625)		 78% (1945/2480)
89% (2200/2480)
87% (2166/2480)
54% (1342/2480)

Notes: *Immunogenicity taken 1 month after 3rd dose, adverse events taken after 1 month of the 3rd dose; **Titers >1:5; ***No disaggregated data available.