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