Immunogenicity and Safety Study of 4th LBVH0101 After the Primary Vaccination in LG-VHCL002 Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Infectious Disease by Haemophilus Influenzae Type b

Intervention / Treatment
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* Biological: LBVH0101 (Hib vaccine)
* Biological: Hiberix™ Vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 15 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LBVH0101<br> | Biological: LBVH0101 (Hib vaccine)<br>* 0.5mL<br>|
| Active Comparator: Hiberix<br> | Biological: Hiberix™ Vaccine<br>* 0.5mL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of the subjects who obtained protective Ab response with anti-PRP Ab titer ≥ 1 ㎍/mL after 4th vaccination |  | at 4 weeks after 4th vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Communicable Diseases, Infection, Influenza, Orthomyxoviridae Infections, RNA Virus Infections, Virus Diseases, Respiratory Tract Infections, Respiratory Tract Diseases