Healthy Clinical Trial
Official title:
A Single Center, Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase I Clinical Trial for Safety and Preliminary Immunogenicity of a Whole Virus Inactivated Influenza H5N1 Vaccine in Healthy Adolescents and Adults, on Day 0 and 21 Intramuscularly
Influenza is an acute respiratory infection caused by influenza virus with high incidence
and serious complications even causing death. According to the announcement released by the
World Health Organization (WHO), the number of global annual influenza case was 0.6 to 1.2
billion and 0.5 to 1 million people died. The emergence of a new subtype of influenza virus
may cause an influenza pandemic with occurence once every 10 to 50 years which cause serious
adverse consequences for human health and social welfare worldwide.
From 1997 to 2003，the H5N1 virus infection has increased highly and gradually spreaded to
Europe, Africa and other countries and regions. High mortality caused by H5N1 virus has
attracted the WHO and national government great attention. So it is meaningful to develop
vaccine to provide effective antibody to reduce the number of infections.
The objective of this study is to evaluate the safety and preliminary immunogenicity of a
whole virus inactivated influenza H5N1 vaccine.
n/a
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
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