Back to resultsImmunogenicity and Safety Study of 4th LBVH0101 After the Primary Vaccination in LG-VHCL002 Study
Primary Purpose
Infectious Disease by Haemophilus Influenzae Type b
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
LBVH0101 (Hib vaccine)
Hiberix™ Vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Infectious Disease by Haemophilus Influenzae Type b focused on measuring Communicable Diseases, Infection, Influenza, Orthomyxoviridae Infections, RNA Virus Infections, Virus Diseases, Respiratory Tract Infections, Respiratory Tract Diseases
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Korea University Ansan Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LBVH0101
Hiberix
Arm Description
Outcomes
Primary Outcome Measures
Percentage of the subjects who obtained protective Ab response with anti-PRP Ab titer ≥ 1 ㎍/mL after 4th vaccination
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01251133
Brief Title
Immunogenicity and Safety Study of 4th LBVH0101 After the Primary Vaccination in LG-VHCL002 Study
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
LG Life Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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.
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™, 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infectious Disease by Haemophilus Influenzae Type b
Keywords
Communicable Diseases, Infection, Influenza, Orthomyxoviridae Infections, RNA Virus Infections, Virus Diseases, Respiratory Tract Infections, Respiratory Tract Diseases
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
122 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LBVH0101
Arm Type
Experimental
Arm Title
Hiberix
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
LBVH0101 (Hib vaccine)
Intervention Description
0.5mL
Intervention Type
Biological
Intervention Name(s)
Hiberix™ Vaccine
Intervention Description
0.5mL
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Percentage of the subjects who maintained preventive Ab response with anti-PRP Ab titer ≥ 1㎍/mL prior to 4th vaccination
Title
Percentage of the subjects who maintained preventive Ab response with anti-PRP Ab titer ≥ 0.15㎍/mL prior to 4th vaccination
Title
Percentage of the subjects who obtained preventive Ab response with anti-PRP Ab titer ≥ 0.15㎍/mL after 4th vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
15 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Facility Information:
Facility Name
Korea University Ansan Hospital
City
Ansan
State/Province
Gyeonggi-do
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
22245607
Citation
Kim KH, Kim YK, Kim NH, Chang SH, Lee J, Park EA, Park SE, Eun BW, Lee H, Lee HJ. Immunogenicity and safety of LBVH0101, a new Haemophilus influenzae type b tetanus toxoid conjugate vaccine, compared with Hiberix in Korean infants and children: a randomized trial. Vaccine. 2012 Feb 27;30(10):1886-94. doi: 10.1016/j.vaccine.2011.12.122. Epub 2012 Jan 13.
Results Reference
derived
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Immunogenicity and Safety Study of 4th LBVH0101 After the Primary Vaccination in LG-VHCL002 Study
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