This is a multi-center, comparative, two-arm, parallel-group, single-blind, phase III study to assess immunogenicity and safety of 4th LBVH0101 (Haemophilus influenzae type b tetanus toxoid conjugate vaccine) vaccination compared with 4th Hiberix™ vaccination after the same vaccination with primary one in healthy toddlers who completed the primary vaccination with LBVH0101 or Hiberix™ in LG-VHCL002 study.
Primary objective: This study was purposed to compare and assess immunogenicity of 4th LBVH0101 or Hiberix™ vaccination in toddlers who completed the primary vaccination with LBVH0101 or Hiberix™, respectively, in LG-VHCL002 study. Secondary objective: This study was purposed to compare and assess safety of 4th LBVH0101 or Hiberix™ vaccination in toddlers who completed primary vaccination with LBVH0101 or Hiberix™ in LG-VHCL002 study. It was also purposed to assess persistence of immunogenicity prior to 4th vaccination in toddlers who completed the primary vaccination with LBVH0101 or Hiberix™, respectively, in LG-VHCL002 study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
122
0.5mL
0.5mL
Korea University Ansan Hospital
Ansan, Gyeonggi-do, South Korea
Percentage of the subjects who obtained protective Ab response with anti-PRP Ab titer ≥ 1 ㎍/mL after 4th vaccination
Time frame: at 4 weeks after 4th vaccination
Percentage of the subjects who maintained preventive Ab response with anti-PRP Ab titer ≥ 1㎍/mL prior to 4th vaccination
Percentage of the subjects who maintained preventive Ab response with anti-PRP Ab titer ≥ 0.15㎍/mL prior to 4th vaccination
Percentage of the subjects who obtained preventive Ab response with anti-PRP Ab titer ≥ 0.15㎍/mL after 4th vaccination
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