The objective of this study was to know the safety of DTP/Hepatitis B and Hib/PRP-T vaccine and immediate reactions within the first 30 minutes after injection.
This trial was an open-label study, no randomization, and no placebo or control group. Total 30 healthy infants (age 6-11 weeks) followed this trial. The safety was assessed within 24 hours, 48 hours, 72 hours, and 28 days after injection.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
30
DPT/HepatitisB/Hib vaccine (Bio Farma)
Hasan Sadikin Hospital
Bandung, West Java, Indonesia
Incidence rate of adverse event of DTP/Hepatitis B/Hib vaccine (Bio Farma)
Local and systemic reactions
Time frame: 30 minutes
Incidence rate of adverse event of DTP/Hepatitis B/Hib vaccine (Bio Farma)
Local and systemic reaction
Time frame: 28 hours, 48 hours, 72 hours, 28 days
To asses the immunogenicity
Percentage of infants with increasing antibody
Time frame: 28 days
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