NCT01676675

A Phase I Clinical Trial With Whole Virus Inactivated Influenza H5N1 Vaccine in Healthy Adolescents and Adults

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Jiangsu Province Centers for Disease Control and Prevention · Network
• Sex: All
• Age: 12 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	7.5μg /0.5ml	whole virus inactivated influenza H5N1 vaccine of 7.5μg /0.5ml, two doses, 21 days interval
BIOLOGICAL	15.0μg /0.5ml	whole virus inactivated influenza H5N1 vaccine of 15.0μg /0.5ml, two doses, 21 days interval
BIOLOGICAL	30.0μg /0.5ml	whole virus inactivated influenza H5N1 vaccine of 30.0μg /0.5ml, two doses, 21 days interval
BIOLOGICAL	0/0.5ml placebo	0/0.5ml placebo, two doses, 21 days interval

Timeline

• Start date: 2012-08-01
• Primary completion: 2013-01-01
• Completion: 2013-03-01
• First posted: 2012-08-31
• Last updated: 2013-03-15

Locations

1 site across 1 country: China