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

LG Chem3 sites in 2 countries1,417 target enrollmentMay 31, 2017

ConditionsPoliomyelitis

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Poliomyelitis
Sponsor: LG Chem
Enrollment: 1417
Locations: 3
Primary Endpoint: Stage1: Seroconversion rate(%)
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

May 31, 2017

End Date

June 14, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

LG Chem

Responsible Party

Sponsor

Eligibility Criteria

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