Table 4.
Intention to Treat Analysis | Per Protocol Analysis | |||||
Variables, N (%) |
Group A (n = 75)
Engerix-B |
Group B (n = 75)
Sci-B-Vac |
p Value |
Group A (n = 75)
Engerix-B |
Group B (n = 67)
Sci-B-Vac |
p Value |
HBsAg positivity in children according to Maternal viral loads | ||||||
|
1/11 | 0/18 | 0.3 | 1/11 | 0/17 | 0.3 |
(9.1%) | 0 | (9.1%) | 0 | |||
|
1/39 | 0/37 | 1 | 1/39 | 0/34 | 1 |
(2.6%) | 0 | (2.6%) | 0 | |||
|
0/14 | 0/14 | 1 | 0/14 | 0/11 | 1 |
0 | 0 | 0 | 0 | |||
|
1/4 | 0/3 | 1 | 1/4 | 0/2 | 1 |
(25%) | 0 | (25%) | 0 | |||
|
2/7 | 1/3 | 0.9 | 2/7 | 1/3 | 0.6 |
(28.6%) | (33.3%) | (28.6%) | (33.3%) | |||
Anti-HBc positivity in children according to Maternal viral loads | ||||||
|
3/11 | 1/18 | 0.09 | 3/11 | 1/17 | 0.1 |
(27.3%) | (5.6%) | (27.3%) | (5.9%) | |||
|
11/39 | 12/37 | 0.6 | 11/39 | 12/34 | 0.5 |
(28.2%) | (32.4%) | (28.2%) | (35.3%) | |||
|
5/14 | 5/14 | 1 | 5/14 | 4/11 | 0.9 |
(35.7%) | (35.7%) | (35.7%) | (36.4%) | |||
|
1/4 | 2/3 | 0.3 | 1/4 | 2/2 | 0.4 |
(25%) | (66.7%) | (25%) | (100%) | |||
|
5/7 | 3/3 | 0.9 | 5/7 | 3/3 | 0.9 |
(71.4%) | (100%) | (71.4%) | (100%) |
Analysis excluding the six treated mothers with antivirals in group A and 10 mothers in group B, and excluding the five mothers with missing viral loads (1 in group A and 4 in group B) in the PPA and the ITT analysis.