Who is sponsoring NCT01251133?

NCT01251133 is sponsored by LG Life Sciences.

What condition does NCT01251133 study?

NCT01251133 studies Infectious Disease by Haemophilus Influenzae Type b.

What drugs are being tested in NCT01251133?

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

What is the status of NCT01251133?

NCT01251133 is currently COMPLETED.

Last reviewed 2010-11-30 · How we verify

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

NCT01251133 Phase 3 COMPLETED

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.

Details

Lead sponsor	LG Life Sciences
Phase	Phase 3
Status	COMPLETED
Enrolment	122
Start date	2008-07
Completion	2009-03

Conditions

Infectious Disease by Haemophilus Influenzae Type b

Interventions

LBVH0101 (Hib vaccine)
Hiberix™ Vaccine

Primary outcomes

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

Countries

South Korea