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

NCT01676675 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2013-03-15

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Wuhan Institute of Biological Products Co., Ltd

    collaborator INDUSTRY

  • Jiangsu Province Centers for Disease Control and Prevention

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2013-01-31
Completion
2013-03-31

Countries

  • China

Study Locations

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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 NCT01676675 on ClinicalTrials.gov