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| Sponsor: | Baxter Healthcare Corporation |
|---|---|
| Information provided by: | Baxter Healthcare Corporation |
| ClinicalTrials.gov Identifier: | NCT00711295 |
Purpose
The purpose of this study is to assess the safety and tolerability of, and the immune response to a non-adjuvanted H5N1 influenza vaccine in an adult and elderly population and in specified risk groups. Furthermore, persistence of H5N1 influenza antibodies after vaccination with this vaccine will be assessed.
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza |
Biological: H5N1 Influenza Vaccine Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvanted |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | An Open-Label Phase 3 Study to Assess the Safety and Immunogenicity of a Vero Cell-Derived Whole Virus H5N1 Influenza Vaccine in an Adult and Elderly Population as Well as in Specified Risk Groups |
| Enrollment: | 3583 |
| Study Start Date: | August 2008 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cohort 1, Treatment Arm 1
Stratum A (18-59 ys)/B(>=60 ys): 120 healthy volunteers per stratum will receive 2 vaccinations with 7.5 µg A/Vietnam/1203/2004 on Days 0 and 21 and participate in immunogenicity evaluation. Among Stratum A volunteers, 60 will participate in antibody kinetics evaluation and 30 in cellular immunity evaluation. Randomization to Treatment Arms 1 and 2 at 2:1 ratio. Subjects in Treatment Arm 1 will be included in the immunologic determination of lot-to-lot consistency. |
Biological: H5N1 Influenza Vaccine Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvanted
Intramuscular injection of 7.5 µg hemagglutinin antigen (A/Vietnam/1203/2004 strain) in a non-adjuvanted formulation on Days 0 and 21.
|
|
Experimental: Cohort 1, Treatment Arm 2
Stratum A (18-59 ys)/B(>=60 ys): 60 healthy volunteers per stratum will receive 2 vaccinations with 3.75 µg A/Vietnam/1203/2004 on Days 0 and 21 and participate in immunogenicity evaluation. Randomization to Treatment Arms 1 and 2 at 2:1 ratio. |
Biological: H5N1 Influenza Vaccine Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvanted
Intramuscular injection of 3.75 µg hemagglutinin antigen (A/Vietnam/1203/2004 strain) in a non-adjuvanted formulation on Days 0 and 21.
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|
Experimental: Cohort 1, Treatment Arm 3
Stratum A (18-59 ys): 2060 healthy volunteers will receive 2 vaccinations with 7.5 µg A/Vietnam/1203/2004 on Days 0 and 21 and participate in safety evaluation only. Randomization within Treatment Arms 3 and 4 at 1:1:1 ratio per study site to receive one of three different lots of the H5N1 influenza vaccine. |
Biological: H5N1 Influenza Vaccine Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvanted
Intramuscular injection of 7.5 µg hemagglutinin antigen (A/Vietnam/1203/2004 strain) in a non-adjuvanted formulation on Days 0 and 21.
|
|
Experimental: Cohort 2, Treatment Arm 1
300 immune compromised individuals 18 years or older will receive 2 vaccinations with 7.5 µg A/Vietnam/1203/2004 on Days 0 and 21. 100 will participate in immunogenicity evaluation and 30 in cellular immunity evaluation. |
Biological: H5N1 Influenza Vaccine Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvanted
Intramuscular injection of 7.5 µg hemagglutinin antigen (A/Vietnam/1203/2004 strain) in a non-adjuvanted formulation on Days 0 and 21.
|
|
Experimental: Cohort 3, Treatment Arm 1
300 chronically ill patients 18 years or older will receive 2 vaccinations with 7.5 µg A/Vietnam/1203/2004 on Days 0 and 21 and participate in immunogenicity evaluation.
|
Biological: H5N1 Influenza Vaccine Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvanted
Intramuscular injection of 7.5 µg hemagglutinin antigen (A/Vietnam/1203/2004 strain) in a non-adjuvanted formulation on Days 0 and 21.
|
|
Experimental: Cohort 1, Treatment Arm 4
Stratum A (18-59): 540 healthy volunteers will receive 2 vaccinations with 7.5 µg A/Vietnam/1203/2004 on Days 0 and 21 and participate in immunogenicity assessment. Randomization within Treatment Arms 3 and 4 at 1:1:1 ratio per study site to receive one of three different lots of the H5N1 influenza vaccine. Subjects in Treatment Arm 4 will be included in the immunologic determination of lot-to-lot consistency. |
Biological: H5N1 Influenza Vaccine Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvanted
Intramuscular injection of 7.5 µg hemagglutinin antigen (A/Vietnam/1203/2004 strain) in a non-adjuvanted formulation on Days 0 and 21.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
The following inclusion criteria apply to subjects in all three cohorts:
Male and female subjects will be eligible for participation in this study if they:
The following inclusion criterion applies to subjects in Cohort 1 only:
- Are generally healthy [1], as determined by the investigator's clinical judgment through collection of medical history and performance of a physical examination.
([1]) Subjects with controlled Stage 1 hypertension (blood pressure of 140-159 mmHg systolic and/or 90-99 mmHg diastolic) are eligible for participation in Cohort 1 of this study.
The following inclusion criterion applies to subjects in Cohort 2 only:
- Are immune compromised due to immunosuppressive treatment (e.g. transplant patients [2]) or due to acquired immunodeficiency caused by HIV infection with or without treatment with anti-retrovirals.
([2]) Transplant patients should be at least 6 months after transplantation and in stable clinical condition without complications.
The following inclusion criterion applies to subjects in Cohort 3 only:
- Have a chronic cardiovascular (excluding hypertension) [3], respiratory, renal, or metabolic (e.g. diabetes mellitus) illness in stable clinical condition without major disease complications such as organ failure, infectious complications, severe asthma or respiratory dysfunction.
([3]) Subjects with cardiovascular disease such as coronary heart disease, angina, heart attack or other heart conditions in stable clinical condition, without major disease complications and who are considered at risk for medical complications from influenza. However, subjects with hypertension (see [1] above) not associated with any heart condition will be excluded from participation in Cohort 3 of this study.
Exclusion Criteria:
The following exclusion criteria apply to subjects in all three cohorts:
Subjects will be excluded from participation in this study if they:
The following exclusion criteria apply to subjects in Cohort 1 only:
([4]) A significant disorder is defined as a disease or medical condition associated with impaired health status, increased risk for complications, requiring medical treatment and/or follow up.
The following exclusion criteria apply to subjects in Cohort 2 only:
The following exclusion criterion applies to subjects in Cohort 3 only:
- Have a chronic cardiovascular, respiratory, renal, or metabolic (e.g. diabetes mellitus) illness with significant complications such as advanced heart failure, liver failure, renal failure, severe asthma or severe respiratory failure, infectious complications or other conditions that would be considered a contraindication for vaccination with an inactivated vaccine.
Contacts and Locations
Show 45 Study Locations| Principal Investigator: | Baxter Bio Science Investigator | Baxter Healthcare Corporation |
More Information
| Responsible Party: | Yuri Martina PhD (Clinical Project Manager), Baxter Healthcare Corporation |
| ClinicalTrials.gov Identifier: | NCT00711295 History of Changes |
| Other Study ID Numbers: | 810705 |
| Study First Received: | July 2, 2008 |
| Last Updated: | November 26, 2010 |
| Health Authority: | Austria: Federal Ministry for Health and Women |
|
Influenza (Pandemic) |
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Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |