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Safety and Immunogenicity of an Inactivated Pandemic Influenza Vaccine

Prevention Clinical Trial

Official title:
The Clinical Trial of Pandemic Influenza Vaccine (Whole-Virion， Inactivated, Adjuvanted) on Healthy Adults by Randomized and Double-Blind Design: a Phase II Study

Clinical Trial Summary

A single center, randomized and double-blind phase II clinical trial is to be conducted in adults to evaluate the safety and immunogenicity of an inactivated pandemic influenza vaccine (whole-virion, aluminium-adjuvanted).

Clinical Trial Description

The vaccine to be investigated is producted in embryonated hen's eggs using an H5N1 reference strain NIBRG-14 which was prepared by NIBSC. The strain is a reassortant between A/Vietnam/1194/2004 and A/PR/8/34 by reverse genetics.

Total 400 volunteers aged from 18 to 60 years old are to be enrolled with 100 subjects in each group. The eligible volunteers will receive two doses vaccine of 5μg，10μg or 15μg haemagglutinin antigen. The schedule is day 0,14 or day 0,28. The subjects will donate their blood samples for the detection of HI antibody and microneutralization antibody. Local and systematic adverse reactions will be recorded during the study. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00535665
Study type Interventional
Source Sinovac Biotech Co., Ltd
Contact
Status Completed
Phase Phase 2
Start date September 2007
Completion date November 2007
View Details
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