Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT01251133
Eligibility Criteria:
Inclusion Criteria:
* Were vaccinated with LBVH0101 or Hiberix™ three times in LG-VHCL002 study
* Healthy male and female infants at the age of 12 to 15 months from birth
* The infants and their parents/legally acceptable representative could comply with all of the scheduled visits in the study
* The parents/legally acceptable representative signed the written consent form.
Exclusion Criteria:
* Subject had been vaccinated with 4th shot of Haemophilus influenzae type b
* Subject is scheduled to be administered with any vaccine other than those specified in the protocol as allowed according to the Standard Immunization Schedule, between the 4th vaccination and Completion Visit
* Subject had suffered from any infectious disease caused by Haemophilus influenzae type b
* Subject has fever of ≥ 37.5°C (axillary temperature) at the day of vaccination
* There is a clear or suspected immune function disorder
* Systemic corticosteroid (prednisolone or equivalent \> 0.5 mg/kg/day) was administered for more than 14 days within 30 days prior to administration of the test vaccine or any systemic immunosuppressant was used
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Months
Maximum Age:
15 Months
Study:
NCT01251133
Study Brief:
Protocol Section:
NCT01251133