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Clinical Trial Summary

The purpose of this study is to evaluate the safety and immunogenicity of a single subcutaneous injection of TAK-850 as compared to intramuscular injection of TAK-850 in healthy Japanese adults


Clinical Trial Description

The drug being tested in this study is called TAK-850. This drug is being tested to evaluate the safety and immunogenicity of a single subcutaneous injection as compared to a single, intramuscular injection.

A total of 110 healthy participants (55 per group) will take part in this study.

Each participant will be randomly (like flipping a coin) assigned to receive one of the following :

- A single injection of TAK-850, subcutaneously , or

- A single injection of TAK-850, intramuscularly.

Participants will make up to 3 visits to the study site. Total duration of this study is 22 days. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT02313155
Study type Interventional
Source Takeda
Contact
Status Completed
Phase Phase 1/Phase 2
Start date December 2014
Completion date January 2015

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