NCT00535665

Safety and Immunogenicity of an Inactivated Pandemic Influenza Vaccine

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 402 (actual)
• Sponsor: Sinovac Biotech Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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).

Detailed 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.

Conditions

• Pandemic Influenza
• Prevention

Interventions

Type	Name	Description
BIOLOGICAL	pandemic influenza vaccine (H5N1 strain NIBRG-14)	two-dose regimen with 14 days apart: 5 microgram per dose
BIOLOGICAL	pandemic influenza vaccine (H5N1 strain NIBRG-14)	two-dose regimen with 28 days apart: 5 microgram per dose
BIOLOGICAL	pandemic influenza vaccine (H5N1 strain NIBRG-14)	two-dose regimen with 28 days apart: 10 microgram per dose
BIOLOGICAL	pandemic influenza vaccine (H5N1 strain NIBRG-14)	two-dose regimen with 28 days apart: 15 microgram per dose

Timeline

• Start date: 2007-09-01
• Completion: 2007-11-01
• First posted: 2007-09-26
• Last updated: 2007-11-09