Prevention of pertussis, diphtheria, tetanus, acute poliomyelitis, and invasive disease caused by Haemophilus influenzae type b
Conditions
Sponsors
KM Biologics Co.,Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy - Seropositivity rate (>= 1mcg/mL) against polyribosyl ribitol phosphate after primary immunization - Seropositivity rates against pertussis toxin, filamentous hemagglutinin, diphtheria toxin, tetanus toxoid, poliovirus types 1, 2, and 3 (Sabin strain) after primary immunization | — |
Secondary
| Measure | Time frame |
|---|---|
| safety - Seropositivity rate (>= 0.15mcg/mL) against polyribosyl ribitol phosphate after primary immunization - Seropositivity rates against poliovirus types 1 (Mahoney strain), 2 (MEF-1 strain), and 3 (Saukett strain) after primary immunization - Seropositivity rate (>= 1mcg/mL and >= 0.15mcg/mL) against polyribosyl ribitol phosphate after booster immunization - Seropositivity rates against pertussis toxin, filamentous hemagglutinin, diphtheria toxin, tetanus toxoid, poliovirus types 1, 2, and 3 (Sabin strain), and poliovirus types 1 (Mahoney strain), 2 (MEF-1 strain), and 3 (Saukett strain) after booster immunization - The geometric mean titers against polyribosyl ribitol phosphate, pertussis toxin, filamentous hemagglutinin, diphtheria toxin, tetanus toxoid, poliovirus types 1, 2, and 3 (Sabin strain), and poliovirus types 1 (Mahoney strain), 2 (MEF-1 strain), and 3 (Saukett strain) after primary immunization - The geometric mean titers against polyribosyl ribitol phosphate, pertussis toxin, filamentous hemagglutinin, diphtheria toxin, tetanus toxoid, poliovirus types 1, 2, and 3 (Sabin strain), and poliovirus types 1 (Mahoney strain), 2 (MEF-1 strain), and 3 (Saukett strain) after booster immunization - Incidence of adverse event - Incidence of adverse drug reaction | — |
Countries
Japan
Contacts
Public ContactMasatoshi Yamashita
KM Biologics Co.,Ltd.
Outcome results
None listed