A Phase IV Study to Assess the Safety of EupentaTM Inj

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}

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}
    

Study Phase

Phase 4

Study Type

Interventional

Primary Outcome

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

Condition

Hepatitis B

Intervention

Eupenta Inj.

Study Arms / Comparison Groups

 Eupenta Inj.

Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Biological

Estimated Enrollment

3000

Start Date

September 23, 2019

Completion Date

December 31, 2020

Primary Completion Date

October 12, 2020

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
      

Gender

All

Ages

6 Weeks - 8 Weeks

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, , 

NCT ID

NCT04056728

Organization ID

LG-VPCL005

Responsible Party

Sponsor

Study Sponsor

LG Chem

Study Sponsor

, , 

Verification Date

August 2019