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

Infectious Disease by Haemophilus Influenzae Type b Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01251133
• Other study ID #: LG-VHCL004
• Status: Completed
• Phase: Phase 3
• First received: November 30, 2010
• Last updated: November 30, 2010
• Start date: July 2008
• Est. completion date: March 2009

Study information

• Verified date: November 2010
• Source: LG Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Months to 15 Months

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Infectious Disease by Haemophilus Influenzae Type b

Intervention

Biological:
• LBVH0101 (Hib vaccine)
0.5mL
• Hiberix™ Vaccine
0.5mL

Locations

Country	Name	City	State
Korea, Republic of	Korea University Ansan Hospital	Ansan	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
LG Life Sciences

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of the subjects who obtained protective Ab response with anti-PRP Ab titer = 1 ?/mL after 4th vaccination		at 4 weeks after 4th vaccination	No
Secondary	Percentage of the subjects who maintained preventive Ab response with anti-PRP Ab titer = 1?/mL prior to 4th vaccination			No
Secondary	Percentage of the subjects who maintained preventive Ab response with anti-PRP Ab titer = 0.15?/mL prior to 4th vaccination			No
Secondary	Percentage of the subjects who obtained preventive Ab response with anti-PRP Ab titer = 0.15?/mL after 4th vaccination			No