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

NCT ID: NCT01251133

Last Updated: 2010-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-03-31

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.

Conditions

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Infectious Disease by Haemophilus Influenzae Type b

Keywords

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Communicable Diseases Infection Influenza Orthomyxoviridae Infections RNA Virus Infections Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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LBVH0101

Group Type EXPERIMENTAL

LBVH0101 (Hib vaccine)

Intervention Type BIOLOGICAL

0.5mL

Hiberix

Group Type ACTIVE_COMPARATOR

Hiberix™ Vaccine

Intervention Type BIOLOGICAL

0.5mL

Interventions

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LBVH0101 (Hib vaccine)

0.5mL

Intervention Type BIOLOGICAL

Hiberix™ Vaccine

0.5mL

Intervention Type BIOLOGICAL

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
Minimum Eligible Age

12 Months

Maximum Eligible Age

15 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LG Life Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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LG Life Sciences

Locations

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Korea University Ansan Hospital

Ansan, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 22245607 (View on PubMed)

Other Identifiers

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LG-VHCL004

Identifier Type: -

Identifier Source: org_study_id