At 12 months of age, the Sci-B-Vac group had lower HBsAg carriage rates (1/89, 1.1%) than the Engerix-B group (5/82, 6.1%) with borderline significance (risk difference of −0.05, 95% CI −0.11–0.007, t -test = 0.05), and borderline significance lower vaccine failure rates with anti-HBs < 10 mIU/mL in the Sci-B-Vac (2/89, 2.2%) than in the Engerix-B (8/82, 9.8%, p = 0.05).
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Efficacy of Birth Dose Vaccination in Preventing Mother-to-Child Transmission of Hepatitis B: A Randomized Controlled Trial Comparing Engerix-B and Sci-B-Vac.
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The limitations of our study include that all pregnant women were recruited into the study at the delivery room, as this led to imbalance of treating women with high viremia during pregnancy with antivirals (6/82 in the Engerix-B vs 10/89 in the Sci-B-Vac groups), the second limitation is that the difference was marginally significant, and the last one is that we analyzed only small number of samples for genetic testing due to the fact that we could not obtain more peripheral blood samples from the other recruited mothers. 5.