A Phase 4 interventional study of Eupenta Inj. in Hepatitis B, Diphtheria and Haemophilus Influenzae Type B Infection, sponsored by LG Chem. Status unknown. Open to participants aged 6 Weeks to 8 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-14.
Sponsored by LG Chem · Phase 4, Interventional, and Prevention
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}
1,662 studies on the registry are indexed under Hepatitis B; 192 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 120 across 1,191 interventional studies indexed under Hepatitis B.
Browse Hepatitis B studies →LG Chem is the lead sponsor of 71 studies on the registry; 8 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 1 (8%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Biological: Eupenta Inj.
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
No study locations are listed for this record.
Start is estimated for Sep 2019; primary completion for Oct 2020, 12 months later.
Of 34 industry-sponsored phase 4 interventional studies under Hepatitis B, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 40. This study's planned 12 months is below that.
Counting every sponsor, half of 112 studies reached it within 40 months; a quarter within 18 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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