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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
1,417
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.
Research Institute for Tropical Medicine
Alabang, Philippines
Mahidol University Faculty of Medicine Siriraj Hospital
Bangkok, Thailand
Chiang Mai University Maharaj Nakhon Chiang Mai Hospital
Chiang Mai, Thailand
Stage1: Seroconversion rate(%)
Proportion of subjects achieving seroconversion of each poliovirus serotype using microneutralization assay
Time frame: 4 weeks after 3rd vaccination
Stage2: Seroconversion rate(%)
Proportion of subjects achieving seroconversion of each poliovirus serotype using microneutralization assay
Time frame: 4 weeks after 3rd vaccination
Stage1: Seroconversion rate (%)
Proportion of subjects achieving seroconversion of each poliovirus serotype using microneutralization assay
Time frame: 4 weeks after 2nd vaccination
Stage2: Seroprotection rate (%)
Proportion of subjects achieving seroprotection of each poliovirus serotype using microneutralization assay
Time frame: 4 weeks after 3rd vaccination
Stage1: GMTs (Geometric Mean Titers)
Comparison of GMTs and GMT ratios
Time frame: 4 weeks after 2nd and 3rd vaccination
Stage2: GMTs (Geometric Mean Titers)
Comparison of GMTs and GMT ratios
Time frame: 4 weeks after 3rd vaccination
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