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Sponsored by: |
Baxter Healthcare Corporation |
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Information provided by: | Baxter Healthcare Corporation |
ClinicalTrials.gov Identifier: | NCT00462215 |
The objectives of this study are to assess the immune response as well as the safety and tolerability of an H5N1 influenza vaccine in an adult and elderly population. Further, the study will assess the need for a booster vaccination and whether a 6-month booster or a 12-month booster is more appropriate. An independent data safety monitoring board will review and evaluate the safety data obtained in this study on an ongoing basis.
Condition | Intervention | Phase |
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Influenza |
Biological: Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigen |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An Open Label Phase III Study of a Vero Cell-Derived Whole Virus H5N1 Influenza Vaccine to Assess the Immunogenicity and Safety and to Investigate the Need for and Timing of a Booster Vaccination |
Estimated Enrollment: | 550 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | June 2009 |
Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Vaccination on Day 0 and Day 21 with the whole virion, Vero cell-derived influenza vaccine containing 7.5 µg H5N1 hemagglutinin (HA) antigen (without adjuvant) of the A/Vietnam/1203/2004 strain + 6-month booster vaccination with the H5N1 vaccine containing 3.75 mg HA antigen strain A/Vietnam/1203/2004
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Biological: Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigen
Vaccination on Day 0 and Day 21 with the whole virion, Vero cell-derived influenza vaccine containing 7.5 µg H5N1 hemagglutinin (HA) antigen (without adjuvant) of the A/Vietnam/1203/2004 strain + 6-month booster vaccination with the H5N1 vaccine containing 3.75 mg HA antigen strain A/Vietnam/1203/2004
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2: Experimental
Vaccination on Day 0 and Day 21 with the whole virion, Vero cell-derived influenza vaccine containing 7.5 µg H5N1 hemagglutinin (HA) antigen (without adjuvant) of the A/Vietnam/1203/2004 strain + 6-month booster vaccination with the H5N1 vaccine containing 7.5 mg HA antigen strain A/Vietnam/1203/2004
|
Biological: Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigen
Vaccination on Day 0 and Day 21 with the whole virion, Vero cell-derived influenza vaccine containing 7.5 µg H5N1 hemagglutinin (HA) antigen (without adjuvant) of the A/Vietnam/1203/2004 strain + 6-month booster vaccination with the H5N1 vaccine containing 7.5 mg HA antigen strain A/Vietnam/1203/2004
|
3: Experimental
Vaccination on Day 0 and Day 21 with the whole virion, Vero cell-derived influenza vaccine containing 7.5 µg H5N1 hemagglutinin (HA) antigen (without adjuvant) of the A/Vietnam/1203/2004 strain + 6-month booster vaccination with the H5N1 vaccine containing 3.75 mg HA antigen strain A/Indonesia/05/2005
|
Biological: Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigen
Vaccination on Day 0 and Day 21 with the whole virion, Vero cell-derived influenza vaccine containing 7.5 µg H5N1 hemagglutinin (HA) antigen (without adjuvant) of the A/Vietnam/1203/2004 strain + 6-month booster vaccination with the H5N1 vaccine containing 3.75 mg HA antigen strain A/Indonesia/05/2005
|
4: Experimental
Vaccination on Day 0 and Day 21 with the whole virion, Vero cell-derived influenza vaccine containing 7.5 µg H5N1 hemagglutinin (HA) antigen (without adjuvant) of the A/Vietnam/1203/2004 strain + 6-month booster vaccination with the H5N1 vaccine containing 7.5 mg HA antigen strain A/Indonesia/05/2005
|
Biological: Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigen
Vaccination on Day 0 and Day 21 with the whole virion, Vero cell-derived influenza vaccine containing 7.5 µg H5N1 hemagglutinin (HA) antigen (without adjuvant) of the A/Vietnam/1203/2004 strain + 6-month booster vaccination with the H5N1 vaccine containing 7.5 mg HA antigen strain A/Indonesia/05/2005
|
5: Experimental
Vaccination on Day 0 and Day 21 with the whole virion, Vero cell-derived influenza vaccine containing 7.5 µg H5N1 hemagglutinin (HA) antigen (without adjuvant) of the A/Vietnam/1203/2004 strain + 12-month booster vaccination with the H5N1 vaccine containing 3.75 mg HA antigen of the A/Indonesia/05/2005 strain
|
Biological: Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigen
Vaccination on Day 0 and Day 21 with the whole virion, Vero cell-derived influenza vaccine containing 7.5 µg H5N1 hemagglutinin (HA) antigen (without adjuvant) of the A/Vietnam/1203/2004 strain + 12-month booster vaccination with the H5N1 vaccine containing 3.75 mg HA antigen of the A/Indonesia/05/2005 strain
|
6: Experimental
Vaccination on Day 0 and Day 21 with the whole virion, Vero cell-derived influenza vaccine containing 7.5 µg H5N1 hemagglutinin (HA) antigen (without adjuvant) of the A/Vietnam/1203/2004 strain + 24-month booster vaccination with the H5N1 vaccine containing 3.75 mg HA antigen of the A/Indonesia/05/2005 strain
|
Biological: Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigen
Vaccination on Day 0 and Day 21 with the whole virion, Vero cell-derived influenza vaccine containing 7.5 µg H5N1 hemagglutinin (HA) antigen (without adjuvant) of the A/Vietnam/1203/2004 strain + 24-month booster vaccination with the H5N1 vaccine containing 3.75 mg HA antigen of the A/Indonesia/05/2005 strain
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Male and female subjects will be eligible for participation in this study if they:
Exclusion Criteria:
Subjects will be excluded from participation in this study if they:
Austria | |
University Hospital, Department of Clinical Pharmacology, General Hospital Vienna | |
Vienna, Austria, 1090 | |
Germany | |
University Hospital Mainz | |
Mainz, Germany, 55101 |
Principal Investigator: | Baxter BioScience Investigator, MD | Baxter Healthcare Corporation |
Responsible Party: | Baxter Healthcare Corporation ( Esther-Maria Imre, Clinical Project Manager ) |
Study ID Numbers: | 810601 |
Study First Received: | April 17, 2007 |
Last Updated: | January 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00462215 |
Health Authority: | Austria: Federal Ministry for Health and Women; Germany: Paul-Ehrlich-Institut |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Influenza, Human Influenza in Birds Orthomyxoviridae Infections |
RNA Virus Infections |