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A Phase I Study to Evaluate the Safety, Reactogenicity, and Humoral Immune Responses to an Inactivated H5N1 Influenza Vaccine

NCT01675284 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2013-10-25

No results posted yet for this study

Summary

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.

Conditions

  • Bird Flu
  • Avian Influenza
  • Influenza A(H5N1)

Interventions

BIOLOGICAL

AT-301

Inactivated H5N1 Influenza Virion Vaccine

Sponsors & Collaborators

  • Medigen Biotechnology Corporation

    lead INDUSTRY

Principal Investigators

  • Pan-Chyr Yang, MD, PhD · National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2013-03-31
Completion
2013-05-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01675284 on ClinicalTrials.gov