KD2-396 II

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031230390

Enrollment

150

Registered

2023-10-12

Start date

2023-10-30

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
- 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.	—

Measure

Time frame

- 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.

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Secondary

Measure	Time frame
- 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.	—

Measure

Time frame

- 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.

—

Contacts

Public ContactYamashita Masatoshi

KM Biologics Co., Ltd.

rinkai-jrct@kmbiologics.com+81-968-37-4073

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026