Status:
COMPLETED
Immunogenicity and Safety Study of 4th LBVH0101 After the Primary Vaccination in LG-VHCL002 Study
Lead Sponsor:
LG Life Sciences
Conditions:
Infectious Disease by Haemophilus Influenzae Type b
Eligibility:
All Genders
12-15 years
Phase:
PHASE3
Brief Summary
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 ...
Detailed Description
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™, res...
Eligibility Criteria
Inclusion
- Were vaccinated with LBVH0101 or Hiberix™ three times in LG-VHCL002 study
- Healthy male and female infants at the age of 12 to 15 months from birth
- The infants and their parents/legally acceptable representative could comply with all of the scheduled visits in the study
- The parents/legally acceptable representative signed the written consent form.
Exclusion
- Subject had been vaccinated with 4th shot of Haemophilus influenzae type b
- Subject is scheduled to be administered with any vaccine other than those specified in the protocol as allowed according to the Standard Immunization Schedule, between the 4th vaccination and Completion Visit
- Subject had suffered from any infectious disease caused by Haemophilus influenzae type b
- Subject has fever of ≥ 37.5°C (axillary temperature) at the day of vaccination
- There is a clear or suspected immune function disorder
- Systemic corticosteroid (prednisolone or equivalent \> 0.5 mg/kg/day) was administered for more than 14 days within 30 days prior to administration of the test vaccine or any systemic immunosuppressant was used
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT01251133
Start Date
July 1 2008
End Date
March 1 2009
Last Update
December 1 2010
Active Locations (1)
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1
Korea University Ansan Hospital
Ansan, Gyeonggi-do, South Korea