Infectious Disease by Haemophilus Influenzae Type b Clinical Trial
Official title:
A Phase III Study to Assess Immunogenicity and Safety of 4th LBVH0101 Vaccination Compared With 4th Hiberix™ Vaccination in Healthy Toddlers Who Completed Primary Vaccination in LG-VHCL002 Study
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01019772 -
Immunogenicity and Safety Study of LBVH0101 in Healthy Infants at Two, Four and Six Months of Age
|
Phase 3 |