Multicenter, evaluator-blind, randomized, parallel-group, comparative study to evaluate immunogenicity and safety by intramuscular injection of KD-370 in infants
- Conditions
- Prevention of pertussis, diphtheria, tetanus, acute poliomyelitis, and invasive disease caused bay Haemophilus influenzae type b
- Registration Number
- JPRN-jRCT2080223918
- Lead Sponsor
- KM Biologics Co., Ltd.
- Brief Summary
As a result of evaluating immunogenicity and safety of intramuscular injection of KD-370 for infants ranging from 2 months or older to under 60 months in comparison to the subcutaneous injection, the immunogenicity was similar in intramuscular and subcutaneous injection. In terms of safety, intramuscular injection was expected to reduce the injection site reaction compared to subcutaneous injection, and it was confirmed to be acceptable safety for children.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 108
Infants who are able to receive 4 doses of the investigational drug at defined intervals between the age of 2 months and 60 months
- Infants who obtain written informed consent from their legally acceptable representatives
- Infants having a medical history of Hib infection, pertussis, diphtheria, tetanus, or acute poliomyelitis (polio) (based on interview of their legally acceptable representatives)
- Infants who have received vaccination for Hib, pertussis, diphtheria, tetanus, or acute poliomyelitis (polio) (Confirm Mother and Child Health Handbook)
- Infants who previously exhibited anaphylaxis by components contained in the investigational drug
- Infants who have received another investigational drug in another clinical trial within 4 months (120 days) prior to administration of investigational drug in this trial or those who plan to participate in another clinical trial during this clinical trial
- Infants with fibrodysplasia ossificans progressiva
- Infants who are judged as ineligible for participation in this clinical trial by the principal investigator or sub-investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method