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}.

PHRR190725-002166

LG-VPCL005

2019-CT0500

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}.

This is a prospective, open-label, single-arm, interventional phase IV study to assess the safety of EupentaTM Inj. administration in infants for active primary immunization against diphtheria, tetanus, pertussis, HB and Hib diseases.
Study population includes infants of either sex who are generally healthy and safe to be enrolled in the study, as per the Investigator’s discretion, who are eligible to receive EupentaTM Inj. vaccination against diphtheria, tetanus, pertussis, HB and Hib, as per local schedule for primary immunization.
The subjects will be required to visit a study site for screening, vaccination and follow-up. Screening and first dose of vaccination will be performed on the same day at Visit 1. The subjects will be required to visit the study site on four occasions: Visit 1 (Screening, first dose of vaccination), Visit 2 (second dose of vaccination) and Visit 3 (third and final dose of vaccination) and Visit 4 (Follow-up).

Ongoing

Active primary immunization against diphtheria, tetanus, pertussis, HB and Hib diseases

To assess the safety of Eupenta TM Inj. By collecting any adverse events following immunization (AEFIs) in vaccinated subjects

Unspecified

Recruiting

• Philippines

Clinical Trial

20190503100235

2019-07-10

0000-00-00

3000

Unspecified

Unspecified

19 Sep 2019

Inclusion Criteria
Each potential subject is eligible to be enrolled in the study only if all of the following criteria are met:
1. Written informed consent obtained from the parent(s) or LAR(s) 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 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
Subjects will be excluded from the study if any of the following criteria is met:
1. Past or present medical history of known or suspected diphtheria, tetanus, pertussis, polio, HB or Hib disease
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 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

Interventional

EupentaTM Inj.

Fully liquid pentavalent vaccine, Adsorbed Diphtheria-Tetanus-whole-cell Pertussis-Hepatitis B (rDNA [recombinant-deoxyribonucleic acid])-Haemophilus influenzae type b conjugate vaccine

Non-Randomized

Open Label

Unspecified

Single

To assess the safety profile of Eupenta TM Inj. when administered to infants as a part of active primary immunization

Phase IV