KD2-396 II
- Conditions
- Prevention of pertussis, diphtheria, tetanus, acute poliomyelitis, Hib infection and hepatitis B
- Registration Number
- JPRN-jRCT2031230390
- Lead Sponsor
- Yasuhiko Shinmura
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
(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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - For KD2-396(L), KD2-396(H) and control vaccination groups at Visit 4, <br>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.<br>-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 Measures
Name Time Method - For KD2-396(L), KD2-396(H) and control vaccination groups at Visit 8,<br>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.<br>-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.<br>-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.<br>-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.