Hepatitis BPhase 4NCT04056728
A Phase IV Study to Assess the Safety of EupentaTM Inj
A Phase 4 study testing Eupenta Inj. in people with Hepatitis B and Diphtheria, run by LG Chem.
Trial 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} Read more about this study
- Who is it for?
- Ages 6 to 8 weeksHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B, Diphtheria, Haemophilus Influenzae Type B Infection
- What is being tested?
- Eupenta Inj.
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- 23 Sep 2019to 31 Dec 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 8 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
About this study
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}
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}
- Being tested
- Eupenta Inj.
- Medical subject headings
- Hepatitis B, Diphtheria, Haemophilus Infections, Tetanus, Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eupenta Inj.Biological
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.
| Study group | Role | What they receive |
|---|---|---|
| Eupenta Inj. | Experimental | Not described Receives: Biological: Eupenta Inj. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of any immediate reactions reported from the study after EupentaTM Inj. Vaccination
Measured: first 30 minutes after each study vaccination
Incidence of solicited local and systemic adverse events (AEs)
Measured: baseline(pre-vaccination) up to 7 days after each vaccination
Incidence of any unsolicited AEs during the entire study
Measured: through study completion, an average of 1 year
Incidence of SAEs during the entire study period
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start23 Sep 2019 (estimated)
- Primary completion12 Oct 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04056728
- Sponsor's protocol ID
- LG-VPCL005
- Status last verified
- Aug 2019
- First submitted
- 1 Aug 2019
- Last updated
- 14 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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}
- ClinicalTrials.gov ID
- NCT04056728
- Acronym / sponsor ID
- LG-VPCL005
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2019 (estimated)
- Primary completion
- 12 Oct 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 14 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eupenta Inj. | Experimental | Biological: Eupenta Inj. |
Who may qualify
- Ages
- 6 to 8 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Biological | Eupenta Inj. |
Primary outcome
Incidence of any immediate reactions reported from the study after EupentaTM Inj. Vaccination
Time frame: first 30 minutes after each study vaccination
Incidence of solicited local and systemic adverse events (AEs)
Time frame: baseline(pre-vaccination) up to 7 days after each vaccination
Incidence of any unsolicited AEs during the entire study
Time frame: through study completion, an average of 1 year
Incidence of SAEs during the entire study period
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Eupenta Inj. in people with Hepatitis B and Diphtheria, run by LG Chem.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of any immediate reactions reported from the study after EupentaTM Inj. Vaccination (time frame: first 30 minutes after each study vaccination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2019.