A Clinical Study to Evaluate the Safety and Immunogenicity of Inactivated Poliomyelitis Vaccine in Healthy Infants

August 27, 2019 updated by: LG Chem

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

The purpose of the study is to evaluate safety and immunogenicity of inactivated poliomyelitis vaccine based on Sabin strain (LBVC) in healthy infants to select optimal dose of LBVC as well as to demonstrate the lot-to-lot consistency and non-inferiority of LBVC.

Study Overview

Study Type

Interventional

Enrollment (Actual)

1417

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Alabang, Philippines
        • Research Institute for Tropical Medicine
      • Bangkok, Thailand
        • Mahidol University Faculty of Medicine Siriraj Hospital
      • Chiang Mai, Thailand
        • Chiang Mai University Maharaj Nakhon Chiang Mai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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
  • Born at full term of pregnancy (Gestational age ≥37 weeks)
  • Body weight ≥ 3.2 kg at the time of screening
  • Born to HIV negative mother
  • The parents or Legally Acceptable Representative (LAR) able to understand and comply with planned study procedures
  • Signed informed consent by subject's parents or Legally Acceptable Representative (LAR)

Exclusion Criteria:

  • Previously received any polio vaccines (OPV or IPV)
  • History of previous or concurrent vaccinations other than HepB, BCG, DTP, Hib, Rotavirus vaccine and PCV
  • History of bleeding disorder contraindicating intramuscular injection.
  • Experienced fever ≥ 38 °C/ 100.4 °F within the past 3 days prior to the screening
  • Receipt of immunoglobulin or blood-derived product since birth
  • History of allergic reactions to any vaccine components, including excipients and preservatives (neomycin, streptomycin and polymyxin B, etc.)
  • Known or suspected immune disorder, or received immunosuppressive therapy
  • History of poliomyelitis
  • History of any neurological disorders or seizures
  • Known or suspected febrile, acute or progressive illness
  • Household contact and/or intimate exposure in the previous 30 days to an individual with poliomyelitis
  • Participation in another interventional trial within 30 days before to the enrollment or simultaneous participation in another clinical study
  • Infants whose families are planning to leave the area of the study site before the end of the study period
  • Infants who is considered unsuitable for the clinical study by the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test group 1
Low dose (Stage2: Lot A) of investigational inactivated poliomyelitis vaccine based on Sabin strains (LBVC)
Investigational IPV based on Sabin strain (LBVC). Should be injected by intramuscular three injections in the anterolateral aspect of thigh at 6, 10 and 14 weeks of age.
Experimental: Test group 2
Middle dose (Stage2: Lot B) of investigational inactivated poliomyelitis vaccine based on Sabin strains (LBVC)
Investigational IPV based on Sabin strain (LBVC). Should be injected by intramuscular three injections in the anterolateral aspect of thigh at 6, 10 and 14 weeks of age.
Experimental: Test group 3
High dose (Stage2: Lot C) of investigational inactivated poliomyelitis vaccine based on Sabin strains (LBVC)
Investigational IPV based on Sabin strain (LBVC). Should be injected by intramuscular three injections in the anterolateral aspect of thigh at 6, 10 and 14 weeks of age.
Active Comparator: Comparator
Cormmercialized inactivated poliomyelitis vaccine based on Sabin strains (Imovax Polio)
Commercialized IPV based on Salk strain (Imovax Polio). Should be injected by intramuscular three injections in the anterolateral aspect of thigh at 6, 10 and 14 weeks of age.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stage1: Seroconversion rate(%)
Time Frame: 4 weeks after 3rd vaccination
Proportion of subjects achieving seroconversion of each poliovirus serotype using microneutralization assay
4 weeks after 3rd vaccination
Stage2: Seroconversion rate(%)
Time Frame: 4 weeks after 3rd vaccination
Proportion of subjects achieving seroconversion of each poliovirus serotype using microneutralization assay
4 weeks after 3rd vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stage1: Seroconversion rate (%)
Time Frame: 4 weeks after 2nd vaccination
Proportion of subjects achieving seroconversion of each poliovirus serotype using microneutralization assay
4 weeks after 2nd vaccination
Stage2: Seroprotection rate (%)
Time Frame: 4 weeks after 3rd vaccination
Proportion of subjects achieving seroprotection of each poliovirus serotype using microneutralization assay
4 weeks after 3rd vaccination
Stage1: GMTs (Geometric Mean Titers)
Time Frame: 4 weeks after 2nd and 3rd vaccination
Comparison of GMTs and GMT ratios
4 weeks after 2nd and 3rd vaccination
Stage2: GMTs (Geometric Mean Titers)
Time Frame: 4 weeks after 3rd vaccination
Comparison of GMTs and GMT ratios
4 weeks after 3rd vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2017

Primary Completion (Actual)

January 18, 2019

Study Completion (Actual)

June 14, 2019

Study Registration Dates

First Submitted

May 11, 2017

First Submitted That Met QC Criteria

May 25, 2017

First Posted (Actual)

May 30, 2017

Study Record Updates

Last Update Posted (Actual)

August 29, 2019

Last Update Submitted That Met QC Criteria

August 27, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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