Influenza Infection Clinical Trial
Official title:
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
The purpose of this study is to evaluate the safety and immunogenicity of an intramuscular injection of TAK-850 in healthy pediatric Japanese participants.
The drug being tested in this study is called TAK-850, that is being developed as a
pediatric vaccine for influenza infection. This study will evaluate the safty and
immunogenicity of TAK-850 in healthy Japanese children when given as a intramuscular
injection
The study will enroll approximately 99 participants (33 per treatment group) to receive
TAK-850 in open label fashon, 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, and
- Two injections of TAK-850/0.25 mL in 6 to 35 months old healthy Japanese children..
Participants will be asked to take body temperature in the evening for seven days post
vaccination and record in the diary provided.
This trial will be conducted at 2 sites in Japan. 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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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