JPRN-jRCT2031230390
Active, not recruiting
Phase 2
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
Yasuhiko Shinmura0 sites150 target enrollmentOctober 12, 2023
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Prevention of pertussis, diphtheria, tetanus, acute poliomyelitis, Hib infection and hepatitis B
- Sponsor
- Yasuhiko Shinmura
- Enrollment
- 150
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •(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.
Outcomes
Primary Outcomes
Not specified
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