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Safety and Immunogenicity of an Inactivated Pandemic Influenza Vaccine

NCT00535665 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 402

Last updated 2007-11-09

No results posted yet for this study

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).

Conditions

  • Pandemic Influenza
  • Prevention

Interventions

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

Sponsors & Collaborators

  • Centers for Disease Control and Prevention, China

    collaborator OTHER_GOV

  • Sinovac Biotech Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Jiang Wu · Beijing Centers for Diseases Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-09-30
Completion
2007-11-30

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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 NCT00535665 on ClinicalTrials.gov