KD2-396 II

JRCT ID: jRCT2031230390

Registered date:12/10/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Prevention of pertussis, diphtheria, tetanus, acute poliomyelitis, Hib infection and hepatitis B
• Date of first enrollment: 30/10/2023
• Target sample size: 150
• Study type: Interventional

Intervention(s)

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.

Outcome(s)

Primary Outcome

- 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.

Secondary Outcome

- 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.

Key inclusion & exclusion criteria

• Age minimum: >= 2month old
• Age maximum: < 6month old
• Gender: Both

Include criteria

(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.

Exclude criteria

(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.

Related Information

• Primary Sponsor: Yasuhiko Shinmura