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Submitted by: Geraldine Guerina 2019-07-17 04:16:29 Last Updated by: Geraldine Guerina 2020-05-14 16:42:02


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).

Start Date Duration in Months Target Completion Date Actual Completion Date
2019-09-19 24 2021-09-19 0000-00-00

Ongoing

Institution Classification Region LTO #
LG Chem, Ltd. Private Business South Korea
Institution Classification Region LTO #
PAREXEL Clinical Research (Philippines) Ltd. Corp. Private Business NCR CDRR-NCR-CRO-4
Institution Region
LG Chem, Ltd. South Korea
Name E-Mail Institution and Institution Address
Rio Aquino Rio.Aquino@parexel.com Makati City, Philippines
Name E-Mail Institution and Institution Address
Ariel Hernandez Ariel.Hernandez@parexel.com Makati City, Philippines
Name Expertise Affiliation
Anna Lisa Ong-Lim, MD Principal Investigator Philippine General Hospital
Anna Ma. Lena Lopez, MD Principal Investigator National Institutes of Health - University of the Philippines - Manila
Delia Caparas-Yu, MD Principal Investigator De La Salle Health Science Institute
Margaret S. Modequillo, MD Principal Investigator Perpetual Succour Hospital
Maria Estrella Ibe, MD Principal Investigator St. Luke's Medical Center - Quezon City
Maria Nerissa Atienza-De Leon, MD Principal Investigator Philippine Heart Center
Maria Rosario Z. Capeding, MD Principal Investigator Tropical Disease Foundation, Inc.
Mervin Edcel Flavier, MD Principal Investigator Southern Philippines Medical Center
Michelle Ylade, MD, MSc Principal Investigator Philippine General Hospital
Mitzi Trinidad-Aseron, MD Principal Investigator University of Perpetual Help DALTA Medical Center
Project Location Institutional Ethics Review Board
Philippine General Hospital Philippine General Hospital Ethics Review Board
National Institutes of Health - University of the Philippines - Manila National Institutes of Health
De La Salle Health Science Institute N/A
Perpetual Succour Hospital Perpetual Succour Hospital Institutional Ethics and Review Board
St. Luke's Medical Center - Quezon City St. Luke's Medical Center Institutional Ethics Review Board
Philippine Heart Center Philippine Heart Center Ethics Review Committee
Tropical Disease Foundation, Inc. Tropical Disease Foundation Institutional Review Board
Southern Philippines Medical Center DOH XI Cluster Ethics Review Committee
Philippine General Hospital Philippine General Hospital Ethics Review Board
University of Perpetual Help DALTA Medical Center University of Perpetual Help DALTA Medical Center Ethics Review Committee

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

LG-VPCL005

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

Date Amendment Classification Reason
2019-07-16 Amendments related to the protocol (1) ICF - LG-VPCL005_Model ICF_V1.1_30Apr2019_Cebuano-Cebu, LG-VPCL005_Model ICF_V1.1_30Apr2019_Cebuano-Davao; (2) Diary Card - LG-VPCL005_Diary Version 1.1 17APR2019_Tag, LG-VPCL005_Diary Version 1.1 17APR2019_Cebuano-Cebu, LG-VPCL005_Diary Version 1.1 17APR2019_Cebuano-Davao; (3) Subject ID Card - LG-VPCL005_Subject Identification Card_version 1.0_04APR2019_Cebuano-Cebu, LG-VPCL005_Subject Identification Card_version 1.0_04APR2019_Cebuano-Davao
2019-08-07 Amendments related to the protocol [1] ICF (a) English LG-VPCL005_Model ICF_V1.2_04Jul2019, (b) Tagalog LG-VPCL005_Model ICF_V1.2_04Jul2019, (c) Cebuano-Cebu LG-VPCL005_Model ICF_V1.2_04Jul2019, (d) Cebuano-Davao LG-VPCL005_Model ICF_V1.2_04Jul2019; [2] Diary Card (a) English LG-VPCL005_Diary Card Version 1.2 04Jul2019, (b) Tagalog LG-VPCL005_Diary Card Version 1.2 04Jul2019, (c) Cebuano-Cebu LG-VPCL005_Diary Card Version 1.2 04Jul2019, (d) Cebuano-Davao LG-VPCL005_Diary Card Version 1.2 04Jul2019; [3] Subject ID Card (a) English LG-VPCL005_Subject Identification Card_version 1.0_28May2019, (b) Tagalog LG-VPCL005_Subject Identification Card_version 1.0_28May2019, (c) Cebuano-Cebu LG-VPCL005_Subject Identification Card_version 1.0_28May2019, (d) Cebuano-Davao LG-VPCL005_Subject Identification Card_version 1.0_28May2019
2020-01-29 Amendments related to the trial arrangements Change of the principal investigator or addition of new ones
2020-04-27 Amendments related to the trial arrangements Change of the principal investigator or addition of new ones

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

Utilization Utilization Info
Publication
Oral Presentation
Drug Literature
Posters
Others
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