Immunogenicity and Safety Study of LBVH0101 in Healthy Infants at Two, Four and Six Months of Age
NCT ID: NCT01019772
Last Updated: 2009-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
217 participants
INTERVENTIONAL
2007-07-31
2008-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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LBVH0101
LBVH0101 (Hib vaccine)
Hiberix
Hiberix™ Vaccine
Interventions
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LBVH0101 (Hib vaccine)
Hiberix™ Vaccine
Eligibility Criteria
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Inclusion Criteria
* 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 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 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.
49 Days
84 Days
ALL
Yes
Sponsors
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LG Life Sciences
INDUSTRY
Responsible Party
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LG Life Sciences
Locations
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Seoul National University Children's Hospital
Seoul, Jongno-gu, South Korea
Countries
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References
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Kim KH, Kim YK, Kim NH, Chang SH, Lee J, Park EA, Park SE, Eun BW, Lee H, Lee HJ. Immunogenicity and safety of LBVH0101, a new Haemophilus influenzae type b tetanus toxoid conjugate vaccine, compared with Hiberix in Korean infants and children: a randomized trial. Vaccine. 2012 Feb 27;30(10):1886-94. doi: 10.1016/j.vaccine.2011.12.122. Epub 2012 Jan 13.
Other Identifiers
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LG-VHCL002
Identifier Type: -
Identifier Source: org_study_id