Group A*

Group C*

Group C - Group A

n/N

% [95% CI}

n/N

% [95% CI}

Difference [95% CI]

Anti-HAV 1
≥20 mIU/mL

161/172

93.60 [88.85; 96.76]

152/164

92.68 [87.57; 96.16]

-0.92 [-6.68;4.69]

Anti-HAV 1
≥5 mIU/mL

169/172

98.3 [94.99; 99.64]

164/164

100 [97.78; 100.00]

1.74 [00.82;5]*

Anti-HAV 2
≥20 mIU/mL

169/169

100.0 [97.7; 100.0]

162/163

99.39 [96.63; 99.98];

-0.61 [-3.39;1.67]*

Anti-HAV 2
≥5 mIU/mL

172/172

100 [97.84; 100.0]

163/164

100 [97.76; 100]

-0.58 [-3.33; 1.62]*
Group A: HAV vaccine on Day 0 and MMR vaccine on Day 28
Group C: Concomitant HAV and MMR vaccines on Day 0
*Non-inferiority of Group C to Group A is demonstrated if the lower limit of the 95% CI of the difference is greater than -5%.
1 MEIA Assay
2 ECLIA Assay
Table 3: Anti-HAV Seroprotection Rate one month after primary vaccination (Day 28).