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Safety and Immunogenicity Study of a Booster Vaccination With a Non-Adjuvanted H5N1 Influenza Vaccine (Follow Up to Study 810501)

NCT00530660 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2015-10-09

No results posted yet for this study

Summary

The purpose of this Phase II follow-up study (to study 810501) is to assess the immunogenicity and safety of a booster vaccination with a non-adjuvanted H5N1 influenza vaccine administered 12 to 17 months after a two-dose regimen of different doses of an adjuvanted or non-adjuvanted H5N1 influenza vaccine in a healthy young adult population. A data safety monitoring board will review the safety data after the booster vaccination. The H5N1 influenza antibody persistence 180 days after the booster vaccination will also be assessed.

Conditions

Interventions

BIOLOGICAL

H5N1 influenza vaccine (whole virion, Vero cell-derived), 7.5 µg HA antigen, non-adjuvanted

All subjects who have completed the Day 42 visit at the Austrian study site in Study 810501 will be invited to receive a booster vaccination, 12 to 17 months after the first vaccination with the A/Vietnam/1203/2004 influenza vaccine administered in Study 810501, with a heterologous whole virion, Vero cell-derived influenza vaccine containing 7.5 mg A/H5N1/Indonesia/05/2005 hemagglutinin (HA) antigen in a non-adjuvanted formulation.

Sponsors & Collaborators

  • Alachua Government Services, Inc.

    lead INDUSTRY

Principal Investigators

  • Baxter BioScience Investigator · Baxter Healthcare Corporation

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2008-05-31
Completion
2008-10-31

Countries

  • Austria

Study Locations

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Entities

Diseases

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 NCT00530660 on ClinicalTrials.gov