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NCT Number: NCT01251133

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

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.

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Key information

Conditions

Infectious Disease by Haemophilus Influenzae Type b Communicable Diseases Disease Attributes Infections Influenza, Human Orthomyxoviridae Infections Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

12 month–15 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Korea University Ansan Hospital

Ansan, Gyeonggi-do, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LBVH0101 (Hib vaccine)

Biological

0.5mL

Hiberix™ Vaccine

Biological

0.5mL

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

Sponsors and collaborators

Lead sponsor

LG Life Sciences

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 1, 2010
Registry last updated
Dec 1, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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