UnknownPhase 4

A Phase IV Study to Assess the Safety of EupentaTM Inj

3,000 participantsStarted 2019-09-23

Plain-language 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}

Who can participate

Age range6 Weeks – 8 Weeks

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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)

Exclusion criteria

✕. 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
✕. 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

What they're measuring

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

Timeframe: first 30 minutes after each study vaccination

Incidence of solicited local and systemic adverse events (AEs)

Timeframe: baseline(pre-vaccination) up to 7 days after each vaccination

Incidence of any unsolicited AEs during the entire study

Timeframe: through study completion, an average of 1 year

Incidence of SAEs during the entire study period

Timeframe: through study completion, an average of 1 year

Trial details

NCT IDNCT04056728

SponsorLG Chem

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-10-12

View on ClinicalTrials.gov More Hepatitis B trials

Who can participate

Age range6 Weeks – 8 Weeks

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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)

Exclusion criteria

✕. 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
✕. 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

What they're measuring

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

Timeframe: first 30 minutes after each study vaccination

Incidence of solicited local and systemic adverse events (AEs)

Timeframe: baseline(pre-vaccination) up to 7 days after each vaccination

Incidence of any unsolicited AEs during the entire study

Timeframe: through study completion, an average of 1 year

Incidence of SAEs during the entire study period

Timeframe: through study completion, an average of 1 year