Clinical trial NCT04056728: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatitis B
Diphtheria
Haemophilus Influenzae Type B Infection
Tetanus
Pertussis
Lead sponsor: LG Chem
Sponsor class: INDUSTRY
First posted: 2019-08-14
Enrollment: 3000
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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}


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

Primary outcomes:
measure: Incidence of any immediate reactions reported from the study after EupentaTM Inj. Vaccination
timeFrame: first 30 minutes after each study vaccination
measure: Incidence of solicited local and systemic adverse events (AEs)
timeFrame: baseline(pre-vaccination) up to 7 days after each vaccination
measure: Incidence of any unsolicited AEs during the entire study
timeFrame: through study completion, an average of 1 year
measure: Incidence of SAEs during the entire study period
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: