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A Multi-center, Randomized, Active-controlled, Parallel-group, Open-label and Phase II Study to Evaluate Immunogenicity and Safety of LBVD (fully liquid hexavalent vaccine; Adsorbed Diphtheria-Tetanus-Pertussis-Hepatitis B(rDNA)- Inactivated Poliomyelitis (Sabin strain) and Haemophilus influenzae type b Conjugate Vaccine) Compared to Co-administration of EupentaTM Inj. (fully liquid pentavalent vaccine; Adsorbed Diphtheria-Tetanus-Pertussis-Hepatitis B(rDNA) and Haemophilus influenzae type b Conjugate Vaccine) and Imovax® Polio (Poliomyelitis Vaccine (inactivated)) in Separate Injections in Healthy Infants at 6-10-14 Weeks of Age as Primary Series

PHRR191010-002186

20190503130110

2019-CT0499

A Multi-center, Randomized, Active-controlled, Parallel-group, Open-label and Phase II Study to Evaluate Immunogenicity and Safety of LBVD (fully liquid hexavalent vaccine; Adsorbed Diphtheria-Tetanus-Pertussis-Hepatitis B(rDNA)- Inactivated Poliomyelitis (Sabin strain) and Haemophilus influenzae type b Conjugate Vaccine) Compared to Co-administration of EupentaTM Inj. (fully liquid pentavalent vaccine; Adsorbed Diphtheria-Tetanus-Pertussis-Hepatitis B(rDNA) and Haemophilus influenzae type b Conjugate Vaccine) and Imovax® Polio (Poliomyelitis Vaccine (inactivated)) in Separate Injections in Healthy Infants at 6-10-14 Weeks of Age as Primary Series

Planned duration of the study (for each subject): About 32 weeks; Total 336 subjects ( Randomized 1:1:1:1, Drop-out rate 10% included) Primary vaccination in infants against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib)

Regime Classification Priority
2017 - 2022 Research to enhance and extend healthy lives Maternal, newborn and child health
Start Date Duration in Months Target Completion Date Actual Completion Date
2019-11-11 3 2020-02-11 0000-00-00

Ongoing

Institution Classification Region LTO #
LG Chem, Ltd. Private Business South Korea N/A
Institution Classification Region LTO #
IQVIA RDS Philippines, Inc. Private Business NCR 3000003797863
Institution Region
LG Chem, Ltd. South Korea
Name E-Mail Institution and Institution Address
Elena Lam QMNL.HealthRegistrymailbox@quintiles.com Unit A, 7th Floor, 8 Rockwell, Hidalgo Drive, Rockwell Center, Makati City, 1210, Philippines
Name E-Mail Institution and Institution Address
Evangeline Costelo Evangeline.Costelo@quintiles.com Unit A, 7th Floor, 8 Rockwell, Hidalgo Drive, Rockwell Center, Makati City, 1210, Philippines
Name Expertise Affiliation
Lulu C. Bravo, MD Pediatric Infectious Diseases National Institutes of Health - University of the Philippines - Manila
Maria Rosario Z. Capeding, MD Principal Investigator Tropical Disease Foundation, Inc.
Salvacion R. Gatchalian, MD Pediatric Infectious Diseases Manila Doctors Hospital
Project Location Institutional Ethics Review Board
National Institutes of Health - University of the Philippines - Manila National Institutes of Health
Tropical Disease Foundation, Inc. Tropical Disease Foundation Institutional Review Board
Manila Doctors Hospital Manila Doctors Hospital Institutional Review Board

Healthy infants who require 3-dose primary vaccination course for diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae
type b (Hib) in accordance to the National Immunization Program

To evaluate immunogenicity and safety of three different doses of LBVD in comparison to coadministration of EupentaTM Inj. and Imovax® Polio in separate injections at four weeks after three-dose primary series at 6-10-14 weeks of age when administered to healthy infants and thereby to select the optimal dose of LBVD based on immunogenicity and safety data compared to EupentaTM Inj. and Imovax® Polio.

Unspecified

Pending

  • Philippines

Clinical Trial

20190503130110

20190503130110

2019-08-07

0000-00-00

336

Unspecified

Unspecified

2019-11-11

Inclusion Criteria
1) A male or female healthy (i.e. free of obvious health problems) infant who have reached at least 42 days (6 weeks) of age and not more than 56 days (8 weeks) of age at the time of first vaccination
2) Born at full term of pregnancy (Gestational age ≥ 37 weeks)
3) Body weight ≥ 3.2 kg at the time of screening
4) Received one dose of HepB mono-vaccine within seven days at birth
5) Born to both HBsAg and HIV negative mother
6) Subject‘s parent(s) or LAR able to understand and comply with planned study procedures
7) Written informed consent by subject‘s parent(s) or LAR
Exclusion Criteria
1) Previously received any dose of diphtheria, tetanus, pertussis, polio (OPV or IPV) and/or Hib containing vaccines
2) History of previous or concurrent vaccinations other than HepB, BCG, rotavirus and pneumococcal vaccines
3) Known or suspected history of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, or Hib diseases
4) Household contact and/or intimate exposure in the previous 30 days to an individual with ascertained diphtheria, pertussis, hepatitis B, polio or Hib diseases
5) Experienced fever ≥ 38°C (100.4°F) within the past three days prior to screening
6) Experienced significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the past seven days prior to screening
7) Known or suspected immune disorder or immunodeficient condition
8) Receipt of immunoglobulin or blood-derived product since birth
9) Chronic administration (defined as more than 14 days) of immunosuppressant or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone, or equivalent, ≥0.5mg/kg/day. Inhaled and topical steroids are allowed.
10) History of bleeding disorder contraindicating intramuscular injection
11) Major congenital defects or serious chronic illness
12) History of any neurological disorders or seizures
13) History of allergic reactions to any vaccine components including excipients and preservatives (neomycin, streptomycin, polymyxin B, yeast or etc.)
14) History of allergic reactions to latex
15) Participation in another interventional trial or received any investigational product within 30 days before to the enrollment
16) Plan to leave the area of the study site before the end of the study period
17) Infants who is considered unsuitable for the clinical study by the investigator

Interventional

1) Fully liquid hexavalent vaccine; Adsorbed Diphtheria-Tetanus-Pertussis-Hepatitis B(rDNA)-Inactivated Poliomyelitis (Sabin strain) and Haemophilus influenzae type b Conjugate Vaccine 2) Fully liquid pentavalent vaccine; Adsorbed Diphtheria-Tetanus- Pertussis-Hepatitis B(rDNA) and Haemophilus influenzae type b Conjugate Vaccine 3) Poliomyelitis Vaccine (inactivated)

To evaluate immunogenicity and safety of three different doses of LBVD in comparison to coadministration of EupentaTM Inj. and Imovax® Polio in separate injections

Date Amendment Classification Reason
2020-01-02 Amendments related to the protocol • Subject’s Parents or Legally Acceptable Representative (LAR)’s Information Sheet and Consent Form ver 3.1 and Abbreviated Information Sheet and Consent Form – For Hepatitis B Screening Test and HIV Test of the Subject’s Mother v 3.0

Randomized

N/A

Unspecified

Parallel

To select the optimal dose of LBVD based on immunogenicity and safety data compared to EupentaTM Inj. and Imovax® Polio.in separate injections in healthy infants at 6-10-14 weeks of age

Phase II

Utilization Utilization Info
Publication
Oral Presentation
Drug Literature
Posters
Others
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