A Phase IV Study to Assess the Safety of EupentaTM Inj

Study Overview
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Brief Summary
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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}

Official Title
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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}

Conditions
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Hepatitis B, Diphtheria, Haemophilus Influenzae Type B Infection, Tetanus, Pertussis

Intervention / Treatment
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* Biological: Eupenta Inj.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent obtained from the parents or legally acceptable representatives (LARs) of the subject who have been informed of the purpose, method, effects, etc., of the study A male or female 6 to 8 weeks of age, inclusive, at the time of the first vaccination In good health as determined by medical history, physical examination, and judgment by the Investigator Body weight 3.2 kg and over at the time of screening Subjects for whom the Investigator believed that their parent(s)/LAR(s) could comply with the requirements of the protocol (e.g., completion of the Subject Diary Cards, return for site visits) Exclusion Criteria: Past or present medical history of known or suspected diphtheria, tetanus, pertussis, polio, HB and/or Hib diseases Any history of allergy to any of the components or excipients of EupentaTM Inj., including aluminum hydroxide, sodium hydrogen phosphate heptahydrate, monobasic sodium phosphate dihydrate, polysorbate and thimerosal Any medical condition which can compromise the infant's safety, as per Investigator's discretion History of seizures or abnormal cerebral signs in the newborn period or other serious neurological abnormality History of bleeding tendencies Household contact and/or intimate exposure with a confirmed case of diphtheria, pertussis, HB, polio and/or Hib diseases within in 30 days prior to screening History of fever ≥ 38°C/ 100.4°F within 3 days prior to screening and/or intake of anti-pyretic/analgesic medication. Subjects who meet this criterion will be rescreened to check the temperature after the temporary condition has resolved and if they are within the window period for age of first vaccination at the time of re-scheduled visit History of previous diphtheria-tetanus-pertussis (DTP), and/or Hib vaccination doses History of previous or concurrent vaccinations other than Bacillus Calmette-Guérin (BCG), HB vaccination at birth, Polio, Rotavirus and Pneumococcal vaccines Known or suspected immune disorders, or, received immunosuppressive therapy Participation 30 days prior to screening in the study or simultaneously in another study and/or received any investigational product

Ages Eligible for Study
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Minimum Age: 6 Weeks
Maximum Age: 8 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eupenta Inj.<br> | Biological: Eupenta Inj.<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |