Immunization Clinical Trial
Official title:
A Randomized, Double-Blind, Multicenter, Parallel-Group Comparative Phase III Study Evaluating the Efficacy and Safety of TAK-816 Compared With ActHIB in Healthy Infants
The purpose of this study is to evaluate the efficacy (immunogenicity) of TAK-816 when administered to healthy Japanese infants as multiple subcutaneous doses.
Haemophilus Influenzae type b (Hib) is one of the major causes of infectious meningitis in
children, and can also cause sepsis, cellulitis, arthritis, epiglottitis, pneumonia and
myelitis.
TAK-816 is a conjugated Hib vaccine being tested in healthy infants aged 3-6 months at the
time of the first dose.
The objective of this study is to evaluate the efficacy (immunogenicity) and safety of
TAK-816 (10 ϻg/0.5 mL) in comparison with ActHIB (Haemophilus b Conjugate Vaccine) as a
control.
In addition, the efficacy (immunogenicity) and safety of Absorbed Diphtheria-Purified
Pertussis-Tetanus Combined (DPT-TAKEDA) vaccine when TAK-816 and DPT vaccine are
administered concomitantly will also be investigated.
For the Primary Immunization Phase of this study: three doses of TAK-816 or ActHIB 10 µg/0.5
mL and DPT-TAKEDA 0.5 mL will be administered at 4-week intervals over 8 weeks (Visit 1, 2,
3). At4 weeks after the third dose, a follow-up observation and evaluation will be made
(Visit 4).
For the Booster Vaccination Phase of this study: a single dose of TAK-816 or ActHIB 10
µg/0.5 mL and DPT-TAKEDA 0.5 mL will be given at 52 weeks after the third dose (Visit 5). At
4 weeks after the fourth dose, a follow-up observation and evaluation will be made (Visit
6).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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