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A Phase IV Study to Assess the Safety of EupentaTM Inj

NCT04056728 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3000

Last updated 2019-08-14

No results posted yet for this study

Summary

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

  • Hepatitis B
  • Diphtheria
  • Haemophilus Influenzae Type B Infection
  • Tetanus
  • Pertussis

Interventions

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.

Sponsors & Collaborators

  • LG Chem

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Weeks
Max Age
8 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-23
Primary Completion
2020-10-12
Completion
2020-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04056728 on ClinicalTrials.gov