Who is sponsoring NCT01019772?

NCT01019772 is sponsored by LG Life Sciences.

What condition does NCT01019772 study?

NCT01019772 studies Infectious Disease by Haemophilus Influenzae Type b.

What drugs are being tested in NCT01019772?

Interventions: LBVH0101 (Hib vaccine), Hiberix™ Vaccine.

What is the status of NCT01019772?

NCT01019772 is currently COMPLETED.

Last reviewed 2009-11-23 · How we verify

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

NCT01019772 Phase 3 COMPLETED

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.

Details

Lead sponsor	LG Life Sciences
Phase	Phase 3
Status	COMPLETED
Enrolment	217
Start date	2007-07
Completion	2008-08

Conditions

Infectious Disease by Haemophilus Influenzae Type b

Interventions

LBVH0101 (Hib vaccine)
Hiberix™ Vaccine

Primary outcomes

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.

Countries

South Korea