NCT01379846

Study of TAK-816 in Healthy Infants

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 416 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 3 Months – 6 Months
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the efficacy (immunogenicity) of TAK-816 when administered to healthy Japanese infants as multiple subcutaneous doses.

Detailed description

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).

Conditions

• Immunization

Interventions

Type	Name	Description
BIOLOGICAL	TAK-816+ DPT-TAKEDA	TAK-816 0.5 mL and DPT-TAKEDA 0.5.mL, subcutaneous injections, three doses administered at 4-week intervals over 8 weeks, followed by a fourth dose 52 weeks after third dose.
BIOLOGICAL	ActHIB+ DPT-TAKEDA	ActHIB 0.5 mL and DPT-TAKEDA 0.5.mL, subcutaneous injections, three doses administered at 4-week intervals over 8 weeks, followed by a fourth dose 52 weeks after third dose.

Timeline

• Start date: 2011-06-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2011-06-23
• Last updated: 2013-03-05

Locations

22 sites across 1 country: Japan