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

Infectious Disease by Haemophilus Influenzae Type b Clinical Trial

Official title: 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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

n/a

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

• NCT number: NCT01019772
• Study type: Interventional
• Source: LG Life Sciences
• Status: Completed
• Phase: Phase 3
• Start date: July 2007
• Completion date: August 2008