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

This study has been completed.
Sponsor:
Information provided by:
LG Life Sciences
ClinicalTrials.gov Identifier:
NCT01251133
First received: November 30, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Infectious Disease by Haemophilus Influenzae Type b
Biological: LBVH0101 (Hib vaccine)
Biological: Hiberix™ Vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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

Resource links provided by NLM:


Further study details as provided by LG Life Sciences:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of the subjects who maintained preventive Ab response with anti-PRP Ab titer ≥ 1㎍/mL prior to 4th vaccination [ Designated as safety issue: No ]
  • Percentage of the subjects who maintained preventive Ab response with anti-PRP Ab titer ≥ 0.15㎍/mL prior to 4th vaccination [ Designated as safety issue: No ]
  • Percentage of the subjects who obtained preventive Ab response with anti-PRP Ab titer ≥ 0.15㎍/mL after 4th vaccination [ Designated as safety issue: No ]

Enrollment: 122
Study Start Date: July 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LBVH0101 Biological: LBVH0101 (Hib vaccine)
0.5mL
Active Comparator: Hiberix Biological: Hiberix™ Vaccine
0.5mL

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.

  Eligibility

Ages Eligible for Study:   12 Months to 15 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01251133

Locations
Korea, Republic of
Korea University Ansan Hospital
Ansan, Gyeonggi-do, Korea, Republic of
Sponsors and Collaborators
LG Life Sciences
  More Information

No publications provided by LG Life Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Soomin Oh/CRA, LG Life Sciences
ClinicalTrials.gov Identifier: NCT01251133     History of Changes
Other Study ID Numbers: LG-VHCL004
Study First Received: November 30, 2010
Last Updated: November 30, 2010
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by LG Life Sciences:
Communicable Diseases
Infection
Influenza
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

Additional relevant MeSH terms:
Communicable Diseases
Infection

ClinicalTrials.gov processed this record on October 20, 2014