Prevention of pertussis, diphtheria, tetanus, acute poliomyelitis, Hib infection and hepatitis B
Conditions
Interventions
Inoculate KD2-396 intramuscularly 0.5 mL per dose
Sponsors
Shinmura Yasuhiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Subjects who received three doses of vaccine against pertussis, diphtheria, tetanus, acute poliomyelitis (polio), Haemophilus influenzae type b infection (Hib infection) and hepatitis B (as documented in the Maternal and Child Health Handbook) 2)Subjects who can receive the investigational product by 17 months of age 3)Subjects who obtain written informed consent from their legally acceptable representatives
Exclusion criteria
Exclusion criteria: 1)Subjects with a medical history of pertussis, diphtheria, tetanus, acute poliomyelitis (polio), Hib infection, or hepatitis B (based on the interview of their legally acceptable representatives) 2)Subjects who have completed four doses of vaccine against pertussis, diphtheria, tetanus, acute poliomyelitis (polio) and Hib infection (as documented in the Maternal and Child Health Handbook) 3)Subjects who received hepatitis B vaccine and HBIG to prevent vertical transmission 4)Subjects who have exhibited anaphylaxis previously due to ingredients of the investigational product 5)Patients with fibrodysplasia ossificans progressive 6)Subjects who participated in another study and received other investigational products within past 4 months (120 days) from the date of the investigational product vaccination 7)Subjects with an interval of less than 6 months between the third vaccination of DPT-IPV and Hib vaccine and the investigational product vaccination 8)Subjects with an interval of less than 1 month between the third vaccination of hepatitis B vaccine and the investigational product vaccination 9)Subjects who are judged ineligible for participation in this study by the principal investigator or the subinvestigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Geometric mean fold rise (GMFR) for PT, FHA, diphtheria toxin, tetanus toxoid, PRP, and HBsAg before and after the investigational product vaccination -Mean difference in antibody titers (log2) against attenuated poliovirus types 1, 2, 3 before and after the investigational product vaccination -The incidence and causal relationship to the investigational product of all adverse events, adverse events resulting in death, serious adverse events other than death, important adverse events, and severe (Grade 3 or higher) adverse events occurring up to 27 days after the investigational product vaccination -The incidence, severity, number of days to onset, duration, and causal relationship to the investigational product of solicited local adverse events -The incidence, severity, number of days to onset, duration, and causal relationship to the investigational product of solicited systemic adverse events -The incidence, severity, number of days to onset, duration, and causal relationship to the investigational product of unsolicited adverse events -Maximum body temperature from vaccination of the investigational product to 6 days after the investigational product vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| -Prevalence of antibodies above the protective threshold against PT, FHA, diphtheria toxin, tetanus toxoid, attenuated poliovirus types 1, 2, 3, PRP, and HBsAg after the investigational product vaccination -Geometric mean antibody titers (hereafter GMT) against PT, FHA, diphtheria toxin, tetanus toxoid PRP, and HBsAg after the investigational product vaccination -Mean antibody titers (log2) against attenuated poliovirus types 1, 2, 3 after the investigational product vaccination | — |
Contacts
Public ContactMasatoshi Yamashita
KM Biologics Co., Ltd.
Outcome results
None listed