PMID- 11906768
OWN - NLM
STAT- MEDLINE
DCOM- 20021004
LR  - 20190728
IS  - 0264-410X (Print)
IS  - 0264-410X (Linking)
VI  - 20
IP  - 13-14
DP  - 2002 Mar 15
TI  - Comparative efficacy, safety and immunogenicity of Hepavax-Gene and Engerix-B, 
      recombinant hepatitis B vaccines, in infants born to HBsAg and HBeAg positive 
      mothers in Vietnam: an assessment at 2 years.
PG  - 1803-8
AB  - In a randomized, controlled trial, 105 healthy full-term infants born to HBsAg 
      and HBeAg positive mothers received three doses (at 0, 1 and 6 months) of either 
      a new recombinant hepatitis B vaccine (Hepavax-Gene) or Engerix-B. Both groups 
      were also given hepatitis B specific Hepa-big immunoglobulin (HBIG) within 24h of 
      birth. Levels of antibodies to hepatitis B surface antigen (anti-HBs) were 
      assessed on days 30, 60, 210, 360, and 2 years post-vaccination. Efficacy and 
      immunogenicity and safety of the two vaccines were not significantly different; 
      both vaccines achieved >94% seroprotection within 360 days. At 2 years, only one 
      subject (1.9%) in the Hepavax-Gene group and two subjects (3.9%) in the Engerix-B 
      group were HBsAg positive. No serious adverse events (AEs) were observed in 
      either group.
FAU - Hieu, Nguyen Trong
AU  - Hieu NT
AD  - Neonatology Department, Hung Vuong Hospital, Ho Chi Minh City, Viet Nam.
FAU - Kim, Kyung Ho
AU  - Kim KH
FAU - Janowicz, Zbigniew
AU  - Janowicz Z
FAU - Timmermans, Ivo
AU  - Timmermans I
LA  - eng
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (Engerix-B)
RN  - 0 (Hepatitis B Antibodies)
RN  - 0 (Hepatitis B Surface Antigens)
RN  - 0 (Hepatitis B Vaccines)
RN  - 0 (Hepatitis B e Antigens)
RN  - 0 (Vaccines, Synthetic)
SB  - IM
MH  - Child, Preschool
MH  - Female
MH  - Follow-Up Studies
MH  - Hepatitis B/complications/immunology/prevention & control
MH  - Hepatitis B Antibodies/blood
MH  - Hepatitis B Surface Antigens/blood
MH  - Hepatitis B Vaccines/adverse effects/immunology/*pharmacology
MH  - Hepatitis B e Antigens/blood
MH  - Humans
MH  - Infant
MH  - Infant, Newborn
MH  - Male
MH  - Pregnancy
MH  - Pregnancy Complications, Infectious/virology
MH  - Safety
MH  - Vaccines, Synthetic/adverse effects/immunology/*pharmacology
MH  - Vietnam
EDAT- 2002/03/22 10:00
MHDA- 2002/10/09 04:00
CRDT- 2002/03/22 10:00
PHST- 2002/03/22 10:00 [pubmed]
PHST- 2002/10/09 04:00 [medline]
PHST- 2002/03/22 10:00 [entrez]
AID - S0264410X01005187 [pii]
AID - 10.1016/s0264-410x(01)00518-7 [doi]
PST - ppublish
SO  - Vaccine. 2002 Mar 15;20(13-14):1803-8. doi: 10.1016/s0264-410x(01)00518-7.