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

This study has been completed.
Sponsor:
Information provided by:
LG Life Sciences
ClinicalTrials.gov Identifier:
NCT01019772
First received: November 23, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by LG Life Sciences:

Primary Outcome Measures:
  • 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. [ Designated as safety issue: No ]

Enrollment: 217
Study Start Date: July 2007
Study Completion Date: August 2008
Arms Assigned Interventions
Experimental: LBVH0101 Biological: LBVH0101 (Hib vaccine)
Active Comparator: Hiberix Biological: Hiberix™ Vaccine

  Eligibility

Ages Eligible for Study:   49 Days to 84 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01019772

Locations
Korea, Republic of
Seoul National University Children's Hospital
Seoul, Jongno-gu, Korea, Republic of, 110-769
Sponsors and Collaborators
LG Life Sciences
  More Information

No publications provided by LG Life Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gyoung-Jin Choi/Assistant manager, LG Life Sciences
ClinicalTrials.gov Identifier: NCT01019772     History of Changes
Other Study ID Numbers: LG-VHCL002
Study First Received: November 23, 2009
Last Updated: November 23, 2009
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Communicable Diseases
Infection
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 01, 2014