NCT01251133

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: LG Life Sciences · Industry
• Sex: All
• Age: 12 Months – 15 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Infectious Disease by Haemophilus Influenzae Type b

Interventions

Type	Name	Description
BIOLOGICAL	LBVH0101 (Hib vaccine)	0.5mL
BIOLOGICAL	Hiberix™ Vaccine	0.5mL

Timeline

• Start date: 2008-07-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2010-12-01
• Last updated: 2010-12-01

Locations

1 site across 1 country: South Korea