Philippine Health Research Registry
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A study to determine the safety and immunogenicity of a new vaccine for Polio in healthy infants
Last Updated on: 2018-02-06 15:40:30
Registry ID: PHRR170812-001656
Secondary Identification Number: LG-VCCL001; 2016-CT0386


Scientific Title

A prospective, multi-national, multi-center, double-blind, randomized, active controlled, parallel-group, seamless Phase II/III clinical study to evaluate the safety and immunogenicity of ‘LBVC (Sabin Poliomyelitis Vaccine (Inactivated))’ compared with ‘Imovax® Polio (Poliomyelitis Vaccine (Inactivated))’ in healthy infants

Project Description

This study is a multi-national, multi-center, double-blind, randomized, active controlled, parallel-group Phase II/III (Stage I & Stage II) seamless study designed to evaluate the safety and immunogenicity of “LBVC (Sabin Poliomyelitis Vaccine(Inactivated))” compared with “Imovax® Polio (Poliomyelitis Vaccine(Inactivated))” given with 3 doses vaccinations in healthy infants.
 
Stage I is the dose exploration stage to compare the safety and immunogenicity of three doses (Low, Middle and High) of LBVC with Imovax® Polio after vaccination of 3-dose series in healthy infants. The purpose is the select the optimal dose of LBVC for Stage II.
 
Stage II is to assess and compare the safety and immunogenicity of the selected dose of LBVC from Stage I with Imovax® polio after vaccination of 3-dose series in healthy infants and to demonstrate lot-to-lot consistency of three lots of LBVC and non-inferiority of immunogenicity of LBVC against Imovax® polio.

NUHRA Details
NUHRA Regime NUHRA Classification NUHRA Priority
2010 - 2016 Health Technology Development Drug Discovery and Development
Project Duration
Start Date Duration in Months Target Completion Date Actual Completion Date
2017-08-10 8 2018-04-10 0000-00-00
Project Status

Ongoing

Implementing Agency (Primary Sponsor)

Name of Institution Classification Region LTO #
LG Life Sciences, Ltd. Private Business South Korea NA

Cooperating Agency (Secondary Sponsor)

Name of Institution Classification Region LTO #
INC Research Pte. Ltd. Private Business NCR CDRR-NCR-CRO-1

Funding Agency (Sources of Monetary or Material Support)

1. LG Chem

Contact for Public Queries

Name: Email Address: Phone Number: Postal Address:
Yunjeong Yang yangyj@lgchem.com +82-10-4380-2237 LG Gwanghwamun Bldg., 58, Saemunan-ro, Jongno-gu, Seoul 03184, Korea

Contact for Scientific Queries

Name: Email Address: Phone Number: Postal Address:
Yunjeong Yang yangyj@lgchem.com +82-10-4380-2237 LG Gwanghwamun Bldg., 58, Saemunan-ro, Jongno-gu, Seoul 03184, Korea

Investigating Team

Name Expertise Affiliation
Maria Rosario Z. Capeding, MD Pediatrician Research Institute for Tropical Medicine

Health Condition(s) or Problem(s) Studied

Active immunization in infants against poliomyelitis caused by poliovirus.
 

Primary Outcomes

Stage I (Dose exploration)
To compare safety and immunogenicity of three doses (Low, Middle and High) of LBVC with Imovax® polio after vaccination of 3-dose series in healthy infants, and hereby to select optimal dose of LBVC for Stage II.
 
Stage II (Evaluation of safety and immunogenicity)
To assess and compare safety of LBVC with Imovax® polio after vaccination of 3-dose series in healthy infants, and to demonstrate the lot-to-lot consistency of three lots of LBVC and non-inferiority of immunogenicity of LBVC against Imovax® polio.

Key Secondary Outcomes

None

Date of First Enrollment

2017-08-10

Recruitment Status

Completed

Countries of Recruitment

Philippines; Thailand

Research Classification

Clinical Trial

Project Location & Institutional Ethics Review Board Which Approved the Study

Project Location Institutional Ethics Review Board
Research Institute for Tropical Medicine Research Institute for Tropical Medicine Institutional Review Board

FDA Document Tracking Number

20161129175210

FDA / ERC Approval Date

2017-06-20

Amendment Approval Dates/Reasons

None

Key Inclusion and Exclusion Criteria (CT)

Inclusion Criteria:
1. Healthy infants of either sex 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 enrollment
2. Born at full term of pregnancy (Gestational age ≥37 weeks)
3. Body weight ≥ 3.2 kg at the time of screening
4. Born to HIV negative mother
5. The parents or Legally Acceptable Representative (LAR) able to understand and comply with planned study procedures
6. Signed informed consent by subject‟s parents or Legally Acceptable Representative (LAR)
 
Exclusion Criteria:
1. Previously received any polio vaccines (OPV or IPV)
2. History of previous or concurrent vaccinations other than BCG, DTP, Hib, Rotavirus vaccine and PCV
3. History of bleeding disorder contraindicating intramuscular injection.
4. Experienced fever ≥ 38 °C/ 100.4 °F within the past 3 days prior to the screening
5. Receipt of immunoglobulin or blood-derived product since birth
6. History of allergic reactions to any vaccine components, including excipients and preservatives (neomycin, streptomycin and polymyxin B, etc.)
7. Known or suspected immune disorder, or received immunosuppressive therapy
8. History of poliomyelitis
9. History of any neurological disorders or seizures
10. Known or suspected febrile, acute or progressive illness
11. Household contact and/or intimate exposure in the previous 30 days to an individual with poliomyelitis
12. Participation in another interventional trial within 30 days before to the enrollment or simultaneous participation in another clinical study
13. Infants whose families are planning to leave the area of the study site before the end of the study period
14. Infants who is considered unsuitable for the clinical study by the investigator
 

Study Type

Interventional

Intervention Name

LBVC [Sabin Poliovirus Vaccine (Inactivated)]

Intervention Description

LBVC is a poliomyelitis vaccine containing inactivated sabin poliovirus which has been developed by LG Chem and has similar antigens with other currently available inactivated poliomyelitis vaccines such as Imovax® Polio. These vaccines are prescribed for active immunization against poliomyelitis caused by poliovirus. Imovax® Polio, as a control vaccine for this study, has been used worldwide. LBVC will be administered through intramuscular injection in the anterolateral aspect of thigh in infants.

Method of Allocation

Randomized

Masking / Blinding

Double Blind

Masking Details

This study is a double-blind study. Study vaccines have different forms — the test vaccines will be supplied in vials and the comparator will be provided in pre-filled syringes. For this reason, in order to maintain the double-blind, the subjects are administered study vaccines in a separate room without subject‟s parents (or LAR) and investigators by an independent nurse who is unblinded in this study. Therefore, the study-related person (except the responsible person who prepares the randomization code, code manager, and pharmacist) and the subjects should be blinded and should not know randomized group information.

Assignment

Parallel

Purpose

This study is planned Phase II/III (Stage I – Stage II) seamless design. The Phase II (Stage I) trial is a dose exploration study; the safety and immunogenicity of the three intramuscular injections with three doses of test vaccines (each low, middle and high dose of LBVC) and comparator (Imovax® polio) will be evaluated and selected appropriate dose of LBVC for Phase III (Stage II) study. The purpose of the Phase III (Stage II) study is an evaluation of safety and immunogenicity; the safety of selected 3 lots of LBVC will be assessed, and immunogenicity of the lot-to-lot consistency of LBVC and non-inferiority of the LBVC against the Imovax® polio will be evaluated.

Phase

Phase II/III

Target Sample Size (Philippines)

133

Actual Sample Size (Philippines)

0

Reason for the difference between target & actual sample sizes

Unspecified

Date of first enrollment

2017-08-10

Research Utilization

None