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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01019772
Recruitment Status : Completed
First Posted : November 25, 2009
Last Update Posted : November 25, 2009
Information provided by:
LG Life Sciences

Brief 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.

Condition or disease Intervention/treatment Phase
Infectious Disease by Haemophilus Influenzae Type b Biological: LBVH0101 (Hib vaccine) Biological: Hiberix™ Vaccine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 217 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Study Start Date : July 2007
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Tetanus

Arm Intervention/treatment
Experimental: LBVH0101 Biological: LBVH0101 (Hib vaccine)
Active Comparator: Hiberix Biological: Hiberix™ Vaccine

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   49 Days to 84 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy male or female infants aged from 49 days to 84 days at the time of enrollment.
  • 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 previously received Haemophilus influenzae type b vaccine prior to this clinical study.
  • 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 or were suspected for immune function disorders; had previously received or were suspected to receive the immunosuppressive therapy; or had received the immunosuppressive therapy within 30 days prior to participating in the study (including systemic corticosteroids or inhalation corticosteroids) (However, it was not the exclusion criteria to have received corticosteroid therapy (prednisolone equivalent ≤ 0.5 mg/kg/day) not more than for 14 consecutive days at least 30 days before their participation in the study).
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01019772

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Korea, Republic of
Seoul National University Children's Hospital
Seoul, Jongno-gu, Korea, Republic of, 110-769
Sponsors and Collaborators
LG Life Sciences
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Gyoung-Jin Choi/Assistant manager, LG Life Sciences Identifier: NCT01019772    
Other Study ID Numbers: LG-VHCL002
First Posted: November 25, 2009    Key Record Dates
Last Update Posted: November 25, 2009
Last Verified: November 2009
Additional relevant MeSH terms:
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Communicable Diseases
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs