Abstract
Evaluate safety and immunization coverage of a new kind of recombinant Hepatitis B vaccine (HepB) in Ningbo city, China. Two groups were carried out in 2 of 11 randomly selected countries in Ningbo in 2009. All of the infants born from July 1 to December 31, 2009 were enrolled as subjects and received 3 doses of HepB at 0, 1, 6 month. Control group (N = 3452) received current HepB derived from Saccharomyces Cerevisiae Yeast (HepB made by recombinant DNA techniques in Saccharomyces Cerevisiae Yeast, HepB-SCY; 5 μg/0.5 ml per dose) and experimental group (N = 5104) received the new kind of HepB derived from Hansenula polymorpha Yeast (HepB made by recombinant DNA techniques in Hansenula polymorpha Yeast, HepB-HPY; 10 μg/0.5 ml per dose). 3-dose and timely birth dose (TBD) coverage were available and compared between 2 groups. Standard structured questionnaires were applied to record information from parents and hospitals for selecting determinants of coverage. The data were analyzed using stepwise multiple logistic regression models. After each dose, HepB-related adverse events (AEs) and recta-temperature were recorded for 7 days. 3-dose coverage in control group (89.98%) was higher than that in experimental group (χ2 = 575.1173, P < 0.0001). TBD coverage in control and experimental group were 98.41% and 98.53%, respectively. No statistically significant difference in TBD coverage was found between 2 groups (χ2 = 0.0623, P = 0.8029). A total of 9 local AEs were reported, 4 for control group and 5 for experimental group. The percentages of subjects reporting AEs were similar across the 2 vaccination groups. No serious or immediate reactions were found in this study. From logistic models, receiving 10 μg vaccine (odds ratio [OR]:0.38; 95% confidence interval [95%CI]: 0.34-0.44) and mother migrating from other cities (OR: 0.45; 95%CI: 0.42-0.47) were the determinants for non-acceptance of 3 doses of HepB; infants born from low grade hospitals and native mothers contributed to administrate the TBD.