臨床研究等提出・公開システム

A multicenter, rater-blinded, randomized, active-controlled, parallel-assignment study to confirm the safety and immunogenicity of vaccination of KD2-396(L) and KD2-396(H) and to examine the optimal dose of hepatitis b virus surface antigen (hereafter HBsAg) in infants aged >=2 months to < 6 months at the time of the first vaccination

KD2-396 II

Yamamoto Akihiko

KM Biologics Co., Ltd.

1314-1 Kyokushi Kawabe, Kikuchi-shi, Kumamoto, Japan

rinkai-jrct@kmbiologics.com

Masatoshi Yamashita

KM Biologics Co., Ltd.

1314-1 Kyokushi Kawabe, Kikuchi-shi, Kumamoto, Japan

+81-968-37-4073

rinkai-jrct@kmbiologics.com

Complete

Oct. 30, 2023

Interventional

randomized controlled trial

double blind

dose comparison control

parallel assignment

prevention purpose

(1) Infants aged >=2 months to < 6 months at the time of the first vaccination.
(2) Subjects who obtain written informed consent from their legally acceptable representatives.

(1) Subjects with a medical history of pertussis, diphtheria, tetanus, acute poliomyelitis (polio), Haemophilus influenzae type b (hereafter Hib) infection, or hepatitis B.
(2) Subjects who received vaccine against pertussis, diphtheria, tetanus, acute poliomyelitis (polio), Hib infection or hepatitis B.
(3) Subjects who received 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 have participated in another study and received other investigational products within the past 4 months (120 days) from the date of the investigational product vaccination, or who are scheduled to participate in another study during the participation period in this study.
(7) Subjects who are judged ineligible for participation in this study by the principal investigator or the subinvestigator.

Both

Prevention of pertussis, diphtheria, tetanus, acute poliomyelitis, Hib infection and hepatitis B

Investigational vaccine group
KD2-396 is administered intramuscularly 3 times at 0.5 mL at intervals of 27 days to 56 days between doses.
KD2-396 is administered intramuscularly once at 0.5 mL at >=6 months to <18 months after the third vaccination.

Control vaccine group
Adsorbed Diphtheria-Purified Pertussis-Tetanus-Inactivated Polio-Haemophilus type b conjugate Combined Vaccine is administered intramuscularly 3 times at 0.5 mL at intervals of 27days to 56 days between doses.
Adsorbed Diphtheria-Purified Pertussis-Tetanus-Inactivated Polio-Haemophilus type b conjugate Combined Vaccine is administered intramuscularly once at 0.5 mL at >=6 months to <18 months after the third vaccination.
Recombinant adsorbed Hepatitis B Vaccine(yeast-derived) is administered subcutaneously 2 times at 0.25 mL at intervals of 27 days to 56 days between doses.
Recombinant adsorbed Hepatitis B Vaccine(yeast-derived) is administered subcutaneously once at 0.25 mL at intervals of 139 days to 167 days after the first vaccination.

- For KD2-396(L), KD2-396(H) and control vaccination groups at Visit 4,
prevalence of antibodies above the protective threshold required to give prevention against PT, FHA, diphtheria toxin, tetanus toxoid, PRP (PRP includes the protective threshold required to give long-term prevention), and attenuated poliovirus types 1, 2 and 3.
-For KD2-396(L) and KD2-396(H) groups at Visit 4 and Visit 8,and the control vaccination group at Visit 6, prevalence of antibodies above the protective threshold required to give prevention against HBsAg.

- For KD2-396(L), KD2-396(H) and control vaccination groups at Visit 8,
prevalence of antibodies above the protective threshold required to give prevention against PT, FHA, diphtheria toxin, tetanus toxoid, PRP (PRP includes the protective threshold required to give long-term prevention), and attenuated poliovirus types 1, 2 and 3.
-For KD2-396(L), KD2-396(H) and control vaccination groups at Visit 4 and Visit 8,geometric mean antibody titers (hereafter GMT) against PT, FHA, diphtheria toxin, tetanus toxoid and PRP.
-For KD2-396(L), KD2-396(H) and control vaccination groups at Visit 4 and Visit 8,mean antibody titers (log2) against attenuated poliovirus types 1, 2, and 3.
-For KD2-396(L) and KD2-396(H) groups at Visit 4 and Visit 8 and the control vaccination group at Visit 6,GMT against HBsAg.

+81-3-5773-5570

Sept. 05, 2023

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