A Phase IV Study to Assess the Safety of EupentaTM Inj

Hepatitis B Clinical Trial

Official title:

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}

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04056728
• Other study ID #: LG-VPCL005
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: September 23, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: August 2019
• Source: LG Chem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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}

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3000
• Est. completion date: December 31, 2020
• Est. primary completion date: October 12, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Weeks to 8 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Diphtheria
• Haemophilus Infections
• Haemophilus Influenzae Type B Infection
• Hepatitis
• Hepatitis B
• Influenza, Human
• Pertussis
• Tetanus
• Whooping Cough

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
LG Chem

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of any immediate reactions reported from the study after EupentaTM Inj. Vaccination		first 30 minutes after each study vaccination
Primary	Incidence of solicited local and systemic adverse events (AEs)		baseline(pre-vaccination) up to 7 days after each vaccination
Primary	Incidence of any unsolicited AEs during the entire study		through study completion, an average of 1 year
Primary	Incidence of SAEs during the entire study period		through study completion, an average of 1 year