PMID- 26211419
OWN - NLM
STAT- MEDLINE
DCOM- 20160926
LR  - 20181113
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 11
IP  - 12
DP  - 2015
TI  - Safety, immunization coverage and determinants of a new kind of Hepatitis B 
      vaccine firstly applied in Ningbo, China.
PG  - 2819-26
LID - 10.1080/21645515.2015.1066946 [doi]
AB  - 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 mug/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 mug/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 (chi2 = 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 (chi2 = 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 
      mug 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.
FAU - Yang, Sijia
AU  - Yang S
AD  - a Ningbo Municipal Center for Disease Control and Prevention ; Zhejiang , China.
FAU - Ma, Xiao
AU  - Ma X
AD  - a Ningbo Municipal Center for Disease Control and Prevention ; Zhejiang , China.
FAU - Ni, Hongxia
AU  - Ni H
AD  - a Ningbo Municipal Center for Disease Control and Prevention ; Zhejiang , China.
FAU - Zhou, Shaoying
AU  - Zhou S
AD  - a Ningbo Municipal Center for Disease Control and Prevention ; Zhejiang , China.
FAU - Hu, Danbiao
AU  - Hu D
AD  - b Ninghai Municipal Center for Disease Control and Prevention ; Zhejiang , China.
FAU - Shi, Honghui
AU  - Shi H
AD  - c Yuyao Municipal Center for Disease Control and Prevention ; Zhejiang , China.
FAU - Chen, Xiaoying
AU  - Chen X
AD  - a Ningbo Municipal Center for Disease Control and Prevention ; Zhejiang , China.
FAU - Dong, Hongjun
AU  - Dong H
AD  - a Ningbo Municipal Center for Disease Control and Prevention ; Zhejiang , China.
FAU - Xu, Guozhang
AU  - Xu G
AD  - a Ningbo Municipal Center for Disease Control and Prevention ; Zhejiang , China.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20150725
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (Hepatitis B Antibodies)
RN  - 0 (Hepatitis B Vaccines)
RN  - 0 (Vaccines, Synthetic)
SB  - IM
MH  - China
MH  - Hepatitis B/immunology/*prevention & control/virology
MH  - Hepatitis B Antibodies/blood/immunology
MH  - Hepatitis B Vaccines/*adverse effects/*immunology
MH  - Hepatitis B virus/*immunology
MH  - Hospitals
MH  - Humans
MH  - Infant
MH  - Infant, Newborn
MH  - Pichia/genetics/metabolism
MH  - Prospective Studies
MH  - Saccharomyces cerevisiae/genetics/metabolism
MH  - Surveys and Questionnaires
MH  - Vaccination
MH  - Vaccines, Synthetic/adverse effects/*immunology
PMC - PMC4916460
OTO - NOTNLM
OT  - coverage
OT  - determinants
OT  - hepatitis b vaccine
OT  - infants
OT  - safety
EDAT- 2015/07/28 06:00
MHDA- 2016/09/27 06:00
PMCR- 2016/07/25
CRDT- 2015/07/28 06:00
PHST- 2015/07/28 06:00 [entrez]
PHST- 2015/07/28 06:00 [pubmed]
PHST- 2016/09/27 06:00 [medline]
PHST- 2016/07/25 00:00 [pmc-release]
AID - 1066946 [pii]
AID - 10.1080/21645515.2015.1066946 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2015;11(12):2819-26. doi: 10.1080/21645515.2015.1066946. 
      Epub 2015 Jul 25.