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Safety and Immunogenicity of Booster Dose of An Inactivated,Adjuvanted Whole-Virion Pandemic Influenza(H5N1)Vaccine

NCT00660257 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2008-04-17

No results posted yet for this study

Summary

A single center, non-randomized clinical trial in two-dose primed healthy adults to evaluate the safety and immunogenicity of a booster dose of an inactivated pandemic influenza (H5N1) vaccine (whole-virion, aluminium-adjuvanted).

Conditions

  • Pandemic Influenza Vaccine
  • Prevention
  • Pandemic Influenza

Interventions

BIOLOGICAL

pandemic influenza vaccine (H5N1 strain NIBRG-14)

pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 1.25 ug per dose, intramuscular injection

BIOLOGICAL

pandemic influenza vaccine (H5N1 strain NIBRG-14)

pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 2.5 ug per dose, intramuscular injection

BIOLOGICAL

pandemic influenza vaccine (H5N1 strain NIBRG-14)

pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 5.0 ug per dose, intramuscular injection

BIOLOGICAL

pandemic influenza vaccine (H5N1 strain NIBRG-14)

pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 1.25 ug per dose, intramuscular injection

Sponsors & Collaborators

  • Centers for Disease Control and Prevention, China

    collaborator OTHER_GOV

  • Sinovac Biotech Co., Ltd

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
61 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2007-03-31
Completion
2008-03-31

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 NCT00660257 on ClinicalTrials.gov