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

Infectious Disease by Haemophilus Influenzae Type b Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01019772
• Other study ID #: LG-VHCL002
• Status: Completed
• Phase: Phase 3
• First received: November 23, 2009
• Last updated: November 23, 2009
• Start date: July 2007
• Est. completion date: August 2008

Study information

• Verified date: November 2009
• Source: LG Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 49 Days to 84 Days

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Infectious Disease by Haemophilus Influenzae Type b

Intervention

Biological:
• LBVH0101 (Hib vaccine)

• Hiberix™ Vaccine

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Children's Hospital	Seoul	Jongno-gu

Sponsors (1)

Lead Sponsor	Collaborator
LG Life Sciences

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.			No