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

NCT01019772 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 217

Last updated 2009-11-25

No results posted yet for this study

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.

Conditions

  • Infectious Disease by Haemophilus Influenzae Type b

Interventions

BIOLOGICAL

LBVH0101 (Hib vaccine)

BIOLOGICAL

Hiberix™ Vaccine

Sponsors & Collaborators

  • LG Life Sciences

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
49 Days
Max Age
84 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-07-31
Completion
2008-08-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01019772 on ClinicalTrials.gov