Infectious Disease by Haemophilus Influenzae Type b
Conditions
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.
Interventions
BIOLOGICALLBVH0101 (Hib vaccine)
BIOLOGICALHiberix™ Vaccine
Sponsors
LG Life Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
49 Days to 84 Days
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
South Korea
Outcome results
None listed