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Status unknownNCT04056728Updated Aug 14, 2019

A Phase IV Study to Assess the Safety of EupentaTM Inj

A Phase 4 interventional study of Eupenta Inj. in Hepatitis B, Diphtheria and Haemophilus Influenzae Type B Infection, sponsored by LG Chem. Status unknown. Open to participants aged 6 Weeks to 8 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-14.

Sponsored by LG Chem · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Aug 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
3,000
Allocation
Not applicable
Ages
6 Weeks to 8 Weeks
Sex
All
01

Study 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}

02

Conditions studied

  • Hepatitis B
  • Diphtheria
  • Haemophilus Influenzae Type B Infection
  • Tetanus
  • Pertussis
03

In context

Hepatitis B

1,662 studies on the registry are indexed under Hepatitis B; 192 are open to participants now.

This study's planned enrollment of 3,000 is above the median of 120 across 1,191 interventional studies indexed under Hepatitis B.

Browse Hepatitis B studies →

Lead sponsor

LG Chem is the lead sponsor of 71 studies on the registry; 8 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 1 (8%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Weeks to 8 Weeks
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3,000 participants (estimated)

Study arms

  • Experimental
    Eupenta Inj.

    Biological: Eupenta Inj.

Interventions

  • BiologicalEupenta 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.

06

What researchers measure

Primary outcomes

  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

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2019; primary completion for Oct 2020, 12 months later.

Of 34 industry-sponsored phase 4 interventional studies under Hepatitis B, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 40. This study's planned 12 months is below that.

Counting every sponsor, half of 112 studies reached it within 40 months; a quarter within 18 and three quarters within 63.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 1, 2019
First posted
Aug 14, 2019
StartEst.
Sep 23, 2019
Primary completionEst.
Oct 12, 2020
CompletionEst.
Dec 31, 2020
Last update
Aug 14, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 14, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04056728
Lead sponsor
LG Chem
Responsible party
Sponsor
First posted
Aug 14, 2019
Start date
Sep 23, 2019 (estimated)
Primary completion
Oct 12, 2020 (estimated)
Completion
Dec 31, 2020 (estimated)
Last update
Aug 14, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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