A Phase IV Study to Assess the Safety of EupentaTM Inj

NCT ID: NCT04056728

Last Updated: 2019-08-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 3000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-23
• Study Completion Date: 2020-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Eupenta Inj.

Group Type: EXPERIMENTAL

Eupenta Inj.

Intervention Type: 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.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. 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

2. A male or female 6 to 8 weeks of age, inclusive, at the time of the first vaccination

3. In good health as determined by medical history, physical examination, and judgment by the Investigator

4. Body weight 3.2 kg and over at the time of screening

5. 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

1. Past or present medical history of known or suspected diphtheria, tetanus, pertussis, polio, HB and/or Hib diseases

2. 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

3. Any medical condition which can compromise the infant's safety, as per Investigator's discretion

4. History of seizures or abnormal cerebral signs in the newborn period or other serious neurological abnormality

5. History of bleeding tendencies

6. 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

7. 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

8. History of previous diphtheria-tetanus-pertussis (DTP), and/or Hib vaccination doses

9. History of previous or concurrent vaccinations other than Bacillus Calmette-Guérin (BCG), HB vaccination at birth, Polio, Rotavirus and Pneumococcal vaccines

10. Known or suspected immune disorders, or, received immunosuppressive therapy

11. Participation 30 days prior to screening in the study or simultaneously in another study and/or received any investigational product

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 8 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

LG Chem

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

LG-VPCL005

Identifier Type: -

Identifier Source: org_study_id