A multicenter, open-label, uncontrolled study to confirm the safety and immunogenicity of single intramuscular dose of KD2-396 in infants who have completed three doses of DPT-IPV, freeze-dried Haemophilus b vaccine (hereafter Hib vaccine) and hepatitis B vaccine

Shinmura Yasuhiko0 sites30 target enrollmentOctober 26, 2022

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Shinmura Yasuhiko
Enrollment: 30
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

Infants under 17 months of age who have completed three doses of commercially available DPT-IPV, Hib vaccine and HB vaccine were vaccinated a single intramuscular dose of KD2-396 as an additional vaccination. As a result, serious concerns about safety profile for KD2-396 was not observed and KD2-396 was considered as tolerable in clinical. KD2-396 was also shown to be capable of inducing antibodies against PT, FHA, diphtheria toxin, tetanus toxoid, attenuated poliovirus types 1, 2, 3, PRP and HBsAg.

Registry

who.int

Start Date

October 26, 2022

End Date

January 12, 2023

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Shinmura Yasuhiko

Eligibility 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

•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