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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}
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eupenta Inj. | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eupenta Inj. | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of any immediate reactions reported from the study after EupentaTM Inj. Vaccination | first 30 minutes after each study vaccination | |
| Incidence of solicited local and systemic adverse events (AEs) | baseline(pre-vaccination) up to 7 days after each vaccination | |
| Incidence of any unsolicited AEs during the entire study | through study completion, an average of 1 year | |
| Incidence of SAEs during the entire study period | through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D004165 | Diphtheria |
| D006192 | Haemophilus Infections |
| D013742 | Tetanus |
| D014917 | Whooping Cough |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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|
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D016871 | Pasteurellaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D003015 | Clostridium Infections |
| D001885 | Bordetella Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |