臨床研究等提出・公開システム

A multicenter, phase III, evaluator-blinded, randomized, active-controlled, parallel-group comparative study to evaluate the immunogenicity and safety of KD2-396 compared with Quintovac Aqueous Suspension Injection (DTaP-sIPV/Hib) and Bimmugen Injection (HB vaccine) in infants aged >=2 months and <7 months at the time of the first dose

Phase III study of KD2-396

Horita Akira

KM Biologics Co., Ltd.

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

rinkai-jrct@kmbiologics.com

Yamashita Masatoshi

KM Biologics Co., Ltd.

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

+81-968-37-4073

rinkai-jrct@kmbiologics.com

Not Recruiting

Mar. 25, 2026

Interventional

randomized controlled trial

double blind

active control

parallel assignment

prevention purpose

1. Infants aged >=2 months and <7 months at the time of the first dose
2. Written informed consent provided by a legal representative

1. History of pertussis, diphtheria, tetanus, poliomyelitis (polio), Hib infection, or hepatitis B (as reported by a legal representative)
2. Receipt of any vaccine against pertussis, diphtheria, tetanus, poliomyelitis (polio), or Hib infection
3. Receipt of hepatitis B vaccine and hepatitis B immune globulin to prevent vertical transmission
4. History of anaphylaxis due to components of the investigational products
5. Subjects with fibrodysplasia ossificans progressiva
6. Participants in another clinical trial and receipt of another investigational product within 120 days prior to the administration of the study drug
7. Receipt of a blood transfusion or a gamma globulin preparation within 90 days prior to the first dose of the study drug, or high-dose gamma globulin therapy (>=200 mg/kg) within 180 days prior to the first dose
8. Receipt of treatment* affecting immune function within 180 days prior to the first dose of the study drug
*Radiation therapy, immunosuppressants (topical drugs permitted), immunosuppressive therapy, antirheumatic drugs, adrenocorticotropic hormone agents, and adrenocortical steroid preparations (defined as a treatment for>=14 consecutive days at a prednisolone-equivalent dose of >=2 mg/kg/day for those weighing < 10 kg, or >= 20 mg/day for those weighing >= 10 kg; topical drugs are permitted)
9. Others: Subjects deemed inappropriate for participation by the investigator or subinvestigator

Both

Prevention of pertussis, diphtheria, tetanus, poliomyelitis(polio), Hib infection, and hepatitis B

Study drug group
KD2-396 should be administered as follows: Administer 0.5 mL intramuscularly three doses at intervals of 27 to 56 days, followed by one 0.5 mL intramuscular dose 6 to 18 months after the third dose
Control drug group
DTaP-sIPV/Hib should be administered as follows: Administer three 0.5 mL intramuscular doses at intervals of 27 to 56 days, followed by one 0.5 mL intramuscular dose 6-18 months after the third dose
HB vaccine should be administered as follows: Administer two 0.25 mL subcutaneous doses at intervals of 27 to 56-days, followed by a 0.25 mL subcutaneous dose 139 to 167 days after the first dose

-Difference in the proportion of subjects with antibody titers at or above the protective level against hepatitis B virus surface antigen (HBsAg) between the study drug group and the control drug group
-Difference in the proportion of subjects with antibody titers at or above the protective level (long-term protective level for PRP) against PT, FHA, diphtheria toxin, tetanus toxoid, attenuated poliovirus types 1, 2, and 3, and PRP between the study drug group and the control drug group

-Proportion of subjects with antibody titers against HBsAg at or above the protective level in the study drug group and in the control drug group
-Proportion of subjects with antibody titers at or above the protective level (including long-term protective level for PRP) against PT, FHA, diphtheria toxin, tetanus toxoid, attenuated poliovirus types 1, 2, and 3, and PRP in the study drug group and in the control drug group
-Geometric mean antibody titer against HBsAg in the study drug group and in the control drug group
-Geometric mean antibody titers against PT, FHA, diphtheria toxin, tetanus toxoid, and PRP in the study drug group and in the control drug group
-Mean antibody titers (log2) against attenuated poliovirus types 1, 2, and 3 in the study drug group and in the control drug group

+81-3-6459-4580

Jan. 29, 2026

No

none