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KCE reports vol. 6A Prenatale zorg 120
Study Ref Population Intervention Outcomes Results Comments Study
type
EL
the 204 mothers vs. 15/102 HBsAg positive
babies born in control group
(14.7%) p < 0.05 (RR 0.39,
95% CI 0.16 to 0.95)
Lo et al., 4 361 HBeAg positive Group 1: HBV vaccine Hepatitis B virus in HBV carrier rate:
Method of randomisation not RCT 1b
1985 [389] mothers in 3rd trimester alone (38 infants) infants at 6 months
Group 1: 9/38 specified
at obstetric clinic in
(23.7%)
Taipei, Taiwan from Group 2: HBV vaccine
Group 2: 4/36 112 infants received vaccine
September 1982 to and HBIG at birth (36
(11.1%)
and were followed-up for 6
October 1983
infants)
Group 3: 2/38 (5.3%) months or longer
Beasley
et al.,
1983
4
[390]
1026 HbeAg positive
women from 2 large
hospitals in Taipei,
Taiwan, attending
antenatal clinics from
November 1981 through
December 1982
Group 3: HBV vaccine
and HBIG at birth and
1 month of age (38
infants)
Group 1: HBIG at
birth and at 3 months
at which time
vaccination also
initiated (n = 51)
Group 2: HBIG at
birth and vaccine
initiated at 4 to 7 days
old (n = 50)
Group 3: HBIG at
births and vaccination
initiated at 1 month (n
= 58)
All initial vaccination
Hepatitis B virus in
infants at 9 months
Group 1 vs. group 2 RR:
0.47 (95% CI 0.16 to 1.39)
Group 1 vs. group 3 RR:
0.22 (95% CI 0.05 to 0.96)
HBV carrier rate:
Group 1: 1/51 (2.0%) Group
2: 3/50 (6.0%) Group 3: 5/58
(8.6%)
Group 3 vs. group 2 RR:
0.70 (95% CI 0.18 to 2.77)
Group 3 vs. group 1 RR:
0.23 (95% CI 0.03 to 1.88)
Method of randomisation not
indicated
159 infants whose parents gave
consent, were not withdrawn
from the study, who received
the full treatment of the group
to which they were assigned
and were at least 9 months of
age at time of analysis
RCT 1b