A prospective, open-label, interventional phase IV study to assess the safety of EupentaTM Inj.{fully liquid pentavalent vaccine, Adsorbed Diphtheria-Tetanus-whole-cell Pertussis-Hepatitis B (rDNA \[recombinant-deoxyribonucleic acid\])-Haemophilus influenzae type b conjugate vaccine}
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
3,000
fully liquid pentavalent vaccine, Adsorbed Diphtheria-Tetanus-whole-cell Pertussis-Hepatitis B (rDNA \[recombinant-deoxyribonucleic acid\])-Haemophilus influenzae type b conjugate vaccine single dose 0.5 mL/vial The vaccine is given at 6, 10 and 14 weeks of age in infants.
Incidence of any immediate reactions reported from the study after EupentaTM Inj. Vaccination
Time frame: first 30 minutes after each study vaccination
Incidence of solicited local and systemic adverse events (AEs)
Time frame: baseline(pre-vaccination) up to 7 days after each vaccination
Incidence of any unsolicited AEs during the entire study
Time frame: through study completion, an average of 1 year
Incidence of SAEs during the entire study period
Time frame: through study completion, an average of 1 year
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