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A Phase IV Study to Assess the Safety of EupentaTM Inj

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04056728
Recruitment Status : Not yet recruiting
First Posted : August 14, 2019
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
LG Chem

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}

Condition or disease Intervention/treatment Phase
Hepatitis B Diphtheria Haemophilus Influenzae Type B Infection Tetanus Pertussis Biological: Eupenta Inj. Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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}
Estimated Study Start Date : September 23, 2019
Estimated Primary Completion Date : October 12, 2020
Estimated Study Completion Date : December 31, 2020


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.




Primary Outcome Measures :
  1. Incidence of any immediate reactions reported from the study after EupentaTM Inj. Vaccination [ Time Frame: first 30 minutes after each study vaccination ]
  2. Incidence of solicited local and systemic adverse events (AEs) [ Time Frame: baseline(pre-vaccination) up to 7 days after each vaccination ]
  3. Incidence of any unsolicited AEs during the entire study [ Time Frame: through study completion, an average of 1 year ]
  4. Incidence of SAEs during the entire study period [ Time Frame: through study completion, an average of 1 year ]


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Ages Eligible for Study:   6 Weeks to 8 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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Responsible Party: LG Chem
ClinicalTrials.gov Identifier: NCT04056728    
Other Study ID Numbers: LG-VPCL005
First Posted: August 14, 2019    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Whooping Cough
Tetanus
Diphtheria
Haemophilus Infections
Influenza, Human
Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Orthomyxoviridae Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Hepadnaviridae Infections
DNA Virus Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Infection
Clostridium Infections
Gram-Positive Bacterial Infections
Corynebacterium Infections
Actinomycetales Infections
Pasteurellaceae Infections