NCT02555618

Phase 2 Study of TAK-850 in Comparison With Influenza Hemagglutinin (HA) Vaccine in Healthy Adult Participants

A Randomized Double-Blind Parallel-Group Comparative Phase 2 Study to Evaluate the Immunogenicity and Safety of a Single Subcutaneous Injection of TAK-850 in Comparison With Influenza HA Vaccine in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 20 Years – 49 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the immunogenicity and safety of TAK-850 administered subcutaneously as a single dose versus influenza HA vaccination in an exploratory manner.

Detailed description

This study is a phase 2, single dose study of TAK-850 (cell-culture derived TIV) administered subcutaneously in healthy Japanese adults, designed as a randomized, double-blind, parallel-group, comparative study to evaluate the immunogenicity and safety compared to an egg-derived TIV. The drug being tested in this study is called TAK-850. TAK-850 was tested in healthy volunteers. This study looked at immunogenicity and safety of TAK-850 (cell-derived) compared to an egg-derived influenza vaccine. The study enrolled 400 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the two groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need): * TAK-850 * Influenza HA vaccine All participants received one injection. This single center trial was conducted in Japan. The overall time to participate in this study was 22 days. Participants made multiple visits to the clinic, including a final visit 21 days after the vaccination for a follow-up assessment.

Conditions

• Influenza Infection

Interventions

Type	Name	Description
BIOLOGICAL	TAK-850	TAK-850 subcutaneous injection
BIOLOGICAL	Influenza HA vaccine	Influenza HA vaccine subcutaneous injection

Timeline

• Start date: 2015-09-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2015-09-21
• Last updated: 2016-12-29
• Results posted: 2016-12-29