Inactivated Poliomyelitis Vaccine (Sabin strain)
BiologicalInvestigational 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.
NCT Number: NCT03169725
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.
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Notify Me6 week–8 week
All sexes
Interventional
Phase 2 / Phase 3
Research Institute for Tropical Medicine, Alabang, Philippines
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 4 weeks after 3rd vaccination
Proportion of subjects achieving seroconversion of each poliovirus serotype using microneutralization assay
Time frame: 4 weeks after 3rd vaccination
Proportion of subjects achieving seroconversion of each poliovirus serotype using microneutralization assay
Time frame: 4 weeks after 2nd vaccination
Proportion of subjects achieving seroconversion of each poliovirus serotype using microneutralization assay
Time frame: 4 weeks after 3rd vaccination
Proportion of subjects achieving seroprotection of each poliovirus serotype using microneutralization assay
Time frame: 4 weeks after 2nd and 3rd vaccination
Comparison of GMTs and GMT ratios
Time frame: 4 weeks after 3rd vaccination
Comparison of GMTs and GMT ratios
LG Chem
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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