A large-scale randomized controlled trial was conducted.
Immunogenicity of 10 μg Hep-KSC paralleled Engerix-B and outperformed 5 μg Hep-KSC.
Equal efficacy in preventing HBV MTCT was observed for 10 μg HepB-KSC and Engerix-B.
Extensive application of 10 μg Hep-KSC in neonatal immunization might be rational.