NCT01675284

A Phase I, Prospective, Randomized, Open Label, Observer-Blind, Single Center Study to Evaluate the Safety, Reactogenicity and Immunogenicity of an Inactivated H5N1 Influenza Vaccine Produced in Madin-Darby Canine Kidney (MDCK) Cells

Completed Phase 1 Last updated 23 October 2013

What this trial tests

Phase 1 trial testing AT-301 in Bird Flu in 36 participants. Completed in 1 May 2013.

Timeline

1 August 2012

Primary endpoint
1 March 2013

1 May 2013

Quick facts

Lead sponsor	Medigen Biotechnology Corporation
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	36
Start date	1 August 2012
Primary completion	1 March 2013
Estimated completion	1 May 2013
Sites	1 location across Taiwan

Drugs / interventions tested

• AT-301 — full drug profile →

Conditions studied

• Bird Flu — all drugs for Bird Flu →
• Avian Influenza — all drugs for Avian Influenza →
• Influenza A(H5N1) — all drugs for Influenza A(H5N1) →

Sponsor

Medigen Biotechnology Corporation — full company profile →

Who can join

Adults 20 to 60, any sex, with Bird Flu or Avian Influenza. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Signs and symptoms solicited by vaccination
  Time frame: A 7-day follow-up period after each vaccine administration
  Percentage, intensity, and relationship to vaccination of solicited local and general signs and symptoms during a 7-day follow-up period (i.e. day of vaccination and 6 subsequent days) after each administered vaccine.
• Signs and symptoms unsolicited by vaccination
  Time frame: A 21-day follow-up period after each vaccine administration
  Percentage, intensity, and relationship to vaccination of unsolicited local and general signs and symptoms during a 21-day follow-up period (i.e. day of vaccination and 20 subsequent days) after each administered vaccine.
• Occurrence of adverse events and serious adverse events
  Time frame: Up to 180 days after the first vaccine administration
  Occurrence of overall adverse events and serious adverse events up to 180 days after the first administered vaccine.

Sponsor's own description

The focus of this study is to evaluate the safety, reactogenicity and humoral immune responses of the study vaccine when administered at the dose of 7.5 µg HA, 15 µg HA, or 30 µg HA to human subjects.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The safety and immunogenicity of a cell-derived adjuvanted H5N1 vaccine - A phase I randomized clinical trial.
   Cheng A, Hsieh SM, Pan SC, Li YH, et al · · 2019 · cited 2× · PMID 31255574 · DOI 10.1016/j.jmii.2019.03.009