NCT02367885

Phase 1/2 Study of TAK-850 Intramuscular Injection in Healthy Pediatric Participants

An Open-label, Multi-center, Phase 1/2 Study to Evaluate the Safety and Immunogenicity of an Intramuscular Injection of TAK-850 in Healthy Pediatric Subjects

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 6 Months – 19 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and immunogenicity of an intramuscular injection of TAK-850 in healthy pediatric Japanese participants.

Detailed description

The drug being tested in this study is called TAK-850, that is under development as a vaccine for influenza infection. This study will evaluate the safety and immunogenicity of TAK-850 in healthy Japanese children when given as an intramuscular injection. The study will enroll approximately 99 participants (33 per treatment group) to receive TAK-850 in open label fashion, The participants will be assigned to each treatment group as follows: * a single intramuscular injection of TAK-850/0.5 mL in 13 to 19 years old healthy Japanese children, * Two injections of TAK-850/0.5 mL in 3 to 12 years old healthy Japanese children, * Two injections of TAK-850/0.25 mL in 6 to 35 months old healthy Japanese children. The overall time to participate in this trial is 22 days (13-19 years old) or 43 days (6 months to 12 years old). Participants will make up to 2 visits (13-19 years old) or 3 visits (6 months to 12 years old) to the site.

Conditions

• Influenza Infection

Interventions

Type	Name	Description
DRUG	TAK-850 0.5 mL injection	TAK-850 injection
DRUG	TAK-850 0.25 mL injection	TAK-850 intramuscular injection

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2015-02-20
• Last updated: 2016-04-07
• Results posted: 2016-04-07

Locations

2 sites across 1 country: Japan