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CompletedNCT01251133Updated Dec 1, 2010

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

A Phase 3 interventional study of LBVH0101 (Hib vaccine) and Hiberix™ Vaccine in Infectious Disease by Haemophilus Influenzae Type b, sponsored by LG Life Sciences. Completed at 1 site in South Korea. Open to participants aged 12 Months to 15 Months. Per ClinicalTrials.gov, last updated 2010-12-01.

Sponsored by LG Life Sciences (part of LG Chem) · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
122
Allocation
Randomized
Ages
12 Months to 15 Months
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • 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
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In context

Communicable Diseases

4,448 studies on the registry are indexed under Communicable Diseases; 514 are open to participants now.

This study's enrollment of 122 is close to the median of 121 across 2,712 interventional studies indexed under Communicable Diseases.

Browse Communicable Diseases studies →

Lead sponsor

LG Life Sciences is the lead sponsor of 78 studies on the registry; none are open to participants now.

First submitted before LG Life Sciences became part of LG Chem.

Browse LG Life Sciences studies →All LG Chem studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Months to 15 Months
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
122 participants (actual)

Study arms

  • Experimental
    LBVH0101

    Biological: LBVH0101 (Hib vaccine)

  • Active comparator
    Hiberix

    Biological: Hiberix™ Vaccine

Interventions

06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. Percentage of the subjects who maintained preventive Ab response with anti-PRP Ab titer ≥ 1㎍/mL prior to 4th vaccination

  2. Percentage of the subjects who maintained preventive Ab response with anti-PRP Ab titer ≥ 0.15㎍/mL prior to 4th vaccination

  3. Percentage of the subjects who obtained preventive Ab response with anti-PRP Ab titer ≥ 0.15㎍/mL after 4th vaccination

07

Study locations

1 site
  • Korea University Ansan Hospital
    Ansan, Gyeonggi-do, South Korea
08

References and documents

Publications

  • 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. PubMed 22245607 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2008, a primary completion of Mar 2009 and a completion of Mar 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 30, 2010
First posted
Dec 1, 2010
Start
Jul 2008
Primary completionActual
Mar 2009
CompletionActual
Mar 2009
Last update
Dec 1, 2010
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 1, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01251133
Lead sponsor
LG Life Sciences
First posted
Dec 1, 2010
Start date
Jul 2008
Primary completion
Mar 2009
Completion
Mar 2009
Last update
Dec 1, 2010

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.

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