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A Phase IV Study to Assess the Safety of EupentaTM Inj

Primary Purpose

Hepatitis B, Diphtheria, Haemophilus Influenzae Type B Infection

Status

Unknown status

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Eupenta Inj.

About this trial

This is an interventional prevention trial for Hepatitis B

Eligibility Criteria

6 Weeks - 8 Weeks (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Eupenta Inj.

Arm Description

Outcomes

Primary Outcome Measures

Incidence of any immediate reactions reported from the study after EupentaTM Inj. Vaccination

Incidence of solicited local and systemic adverse events (AEs)

Incidence of any unsolicited AEs during the entire study

Incidence of SAEs during the entire study period

Secondary Outcome Measures

Full Information

NCT ID

NCT04056728

First Posted

August 1, 2019

Last Updated

August 13, 2019

Sponsor

LG Chem

1. Study Identification

Unique Protocol Identification Number

NCT04056728

Brief Title

A Phase IV Study to Assess the Safety of EupentaTM Inj

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}

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Unknown status

Study Start Date

September 23, 2019 (Anticipated)

Primary Completion Date

October 12, 2020 (Anticipated)

Study Completion Date

December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

LG Chem

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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}

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

3000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Eupenta Inj.

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

Eupenta Inj.

Intervention Description

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.

Primary Outcome Measure Information:

Title

Incidence of any immediate reactions reported from the study after EupentaTM Inj. Vaccination

Time Frame

first 30 minutes after each study vaccination

Title

Incidence of solicited local and systemic adverse events (AEs)

Time Frame

baseline(pre-vaccination) up to 7 days after each vaccination

Title

Incidence of any unsolicited AEs during the entire study

Time Frame

through study completion, an average of 1 year

Title

Incidence of SAEs during the entire study period

Time Frame

through study completion, an average of 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Weeks

Maximum Age & Unit of Time

8 Weeks

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Learn more about this trial

A Phase IV Study to Assess the Safety of EupentaTM Inj

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