Immunogenicity and Safety Study of LBVH0101 in Healthy Infants at Two, Four and Six Months of Age

November 23, 2009 updated by: LG Life Sciences

A Multicentre, Comparative, Two-arm, Parallel-group, Double-blind, Randomized Phase III Study to Assess Immunogenicity and Safety of LBVH0101 (Haemophilus Influenzae Type b Tetanus Toxoid Conjugate Vaccine) Compared With Hiberix™ Vaccine in Healthy Infants at Two, Four and Six Months of Age

The purpose of this study is to evaluate and compare the immunogenicity and safety of LBVH0101 (Haemophilus influenzae type b tetanus toxoid conjugate vaccine) to that of Hiberix™ at vaccination in healthy infants at their 2, 4, and 6 months of age.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

217

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Jongno-gu
      • Seoul, Jongno-gu, Korea, Republic of, 110-769
        • Seoul National University Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 2 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy male or female infants aged from 49 days to 84 days at the time of enrollment.
  • The gestation period was 37 weeks or longer, and birth weight was 2.5 kg or more.
  • The infants and their parents/legally acceptable representative could comply with all of the scheduled visits in the study and the study requirements related to protocol compliance.
  • The parents/legally acceptable representative (LAR) signed the written consent form.

Exclusion Criteria:

  • Had previously received Haemophilus influenzae type b vaccine prior to this clinical study.
  • Had a plan for vaccination with the vaccine other than those permitted in the protocol based on the standard vaccination schedule.
  • Had been contacted with a patient with confirmed Hib infection within 30 days before the study start.
  • Had had fever of ≥ 37.5°C within the last 3 days (If measured by tympanic thermometer, fever of 38°C or higher)
  • Had or were suspected for immune function disorders; had previously received or were suspected to receive the immunosuppressive therapy; or had received the immunosuppressive therapy within 30 days prior to participating in the study (including systemic corticosteroids or inhalation corticosteroids) (However, it was not the exclusion criteria to have received corticosteroid therapy (prednisolone equivalent ≤ 0.5 mg/kg/day) not more than for 14 consecutive days at least 30 days before their participation in the study).
  • Had received the treatment of parenteral immunoglobulin or blood products after birth.
  • Had allergic history to be considered due to any component of the vaccine including excipients or preservatives.
  • Three preceding generations in an ancestral line were not of Korean heritage.
  • Had or were suspected to have significant disorders of blood, heart, liver, kidney, nervous system, respiratory system, or digestive system, or the investigator decided that the evaluation of study objective might be interrupted.
  • Had been treated with other investigational drug by participating in another clinical trial within 30 days prior to this study entry, or were participating in another clinical study at that time.
  • Had plans to move away from the area of the study site before completing the study.
  • Inappropriate to take part in this clinical study in the principal investigator or sub-investigator's opinion, for the reasons other than above criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LBVH0101
Biological: LBVH0101 (Hib vaccine)
Active Comparator: Hiberix
Biological: Hiberix™ Vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Proportion of subjects who have obtained protective antibody response with anti-PRP antibody titer not less than 1㎍/mL after the 3rd vaccination (at 4 weeks after the 3rd vaccination) in the test group and control group.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LG Life Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

November 23, 2009

First Submitted That Met QC Criteria

November 23, 2009

First Posted (Estimate)

November 25, 2009

Study Record Updates

Last Update Posted (Estimate)

November 25, 2009

Last Update Submitted That Met QC Criteria

November 23, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LG-VHCL002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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