A Phase IV Study to Assess the Safety of EupentaTM Inj

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}

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}

Study Overview

• Status: Unknown
• Conditions: Hepatitis B; Pertussis; Tetanus; Diphtheria; Haemophilus Influenzae Type B Infection
• Intervention / Treatment: Biological: Eupenta Inj.

• Study Type: Interventional
• Enrollment (Anticipated): 3000
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 1 month (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eupenta Inj.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: LG Chem

Study record dates

Study Major Dates

• Study Start (Anticipated): September 23, 2019
• Primary Completion (Anticipated): October 12, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: August 1, 2019
• First Submitted That Met QC Criteria: August 13, 2019
• First Posted (Actual): August 14, 2019

Study Record Updates

• Last Update Posted (Actual): August 14, 2019
• Last Update Submitted That Met QC Criteria: August 13, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Orthomyxoviridae Infections; Clostridium Infections; Corynebacterium Infections; Pasteurellaceae Infections; Hepatitis B; Whooping Cough; Hepatitis; Influenza, Human; Tetanus; Diphtheria; Haemophilus Infections
• Other Study ID Numbers: LG-VPCL005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No