Multicenter, evaluator-blind, randomized, parallel-group, comparative study to evaluate immunogenicity and safety of KD-370 in comparison with simultaneous vaccination with ActHIB(R) and Quattrovac(R) in infants.
- Conditions
- Prevention of pertussis, diphtheria, tetanus, acute poliomyelitis, and invasive disease caused by Haemophilus influenzae type b
- Registration Number
- JPRN-jRCT2080223917
- Lead Sponsor
- KM Biologics Co.,Ltd.
- Brief Summary
Subcutaneously, three doses of KD-370 were administered to infants ranging from 2 months or older to under 60 months as primary immunization, and the immunogenicity of the KD-370 was confirmed to bear comparison with that of simultaneous administration of ActHIB (R) and Quattrovac (R). Moreover, subcutaneous administration of a total of four doses including a booster immunization resulted in higher antibody titers. Also, in terms of the safety of the KD-370, it is considered to have clinically acceptable safety as well as simultaneous administration of ActHIB (R) and Quattrovac (R).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 496
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 who are judged as ineligible for participation in this study 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