InfluenzaPhase 3NCT00711295
Phase 3 Study of a H5N1 Vaccine in Adults, Elderly and Specified Risk Groups
A Phase 3 study testing H5N1 Influenza Vaccine Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvanted in people with Influenza, run by Alachua Government Services, Inc. at 45 sites in 7 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- H5N1 Influenza Vaccine Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvanted
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,583 participants
- Where
- 45 sitesin 7 countries
- Study dates
- Aug 2008to Oct 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
- Are 18 years of age or older on the day of screening;
- Have an understanding of the study and its procedures, agree to its provisions, and give written informed consent prior to study entry;
- Are physically and mentally capable of participating in the study and follow its procedures;
- Agree to keep a daily record of symptoms for the duration of the study;
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- If female of childbearing potential - have a negative urine pregnancy test result within 24 hours prior to the scheduled first vaccination and agree to employ adequate birth control measures for the duration of the study.
- 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.
Who cannot join
- The following exclusion criteria apply to subjects in all three cohorts:
- Subjects will be excluded from participation in this study if they:
- Have a history of exposure to H5N1 virus or a history of vaccination with an H5N1 influenza vaccine;
- Are at high risk of contracting H5N1 influenza infection (e.g. poultry workers);
- Have a history of severe allergic reactions or anaphylaxis;
- Have a rash, dermatological condition or tattoos which may interfere with injection site reaction rating;
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- Have donated blood or plasma within 30 days prior to study entry;
- Have received any live vaccine within 4 weeks or inactivated vaccine within 2 weeks prior to vaccination in this study;
- Have a known or suspected problem with alcohol or drug abuse;
- Were administered an investigational drug within 6 weeks prior to study entry or are concurrently participating in a clinical study that includes the administration of an investigational product;
- Are a member of the team conducting this study or are in a dependent relationship with one of the study team members. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator or site personnel conducting the study;
- If female: are pregnant or lactating.
- The following exclusion criteria apply to subjects in Cohort 1 only:
- Currently have or have a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder [4];
- Have any inherited or acquired immunodeficiency;
- Have a disease or are currently undergoing a form of treatment or were undergoing a form of treatment within 30 days prior to study entry that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled (>800µg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs;
- Have received a blood transfusion or immunoglobulins within 90 days prior to study entry;
- Have a functional or surgical asplenia.
- ([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:
- Are immune compromised due to stem cell or organ-transplantation with significant medical complications such as acute or chronic graft rejection or graft versus host disease requiring intensive immunosuppressive treatment, transplant failure or infectious complications or other conditions that would be considered a contraindication for vaccination with an inactivated vaccine.
- Are immune compromised due to HIV infection with a CD4 count of < 200x10^6/L at screening or significant medical complications such as opportunistic infections, malignant complications (e.g. lymphoma, Kaposi sarcoma), other organ manifestations consistent with advanced acquired immunodeficiency syndrome (AIDS) or other conditions that would be considered a contraindication for vaccination with an inactivated vaccine.
- 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.
Trial locations and contacts
45 sites in 7 countries.
45 sites in 7 countries
Germany11 sites
Charité - Universitaetsmedizin Berlin, Medizinische Klinik III, Haematologie, Onkologie & Transfusionsmedizin, Karl Landsteiner-Haus, 1 OG, Hindenburgdamm 30
Berlin, 12200
Klinische Forschung Berlin Buch GmbH, Robert-Rössle-Str. 10 / Haus 85
Berlin, 13125
Klinikum der Universitaet zu Koeln, Klinik I für Innere Medizin, Studienbüro für Infektiologie, Haus 11, Kerpener Str. 62
Cologne, 50937
Carl Gustav Carus Universitaet, Medizinische Klinik und Poliklinik I, Haematologie/Onkologie Fetscherstr. 74
Dresden, 01307
Klinikum der J.W.Goethe Universitaet, Medizinische Klinik II Schwerpunkt HIV Haus 68, Theodor-Stern-Kai 7
Frankfurt am Main, 60590
Klinische Forschung Hamburg GmbH, Hoheluftchaussee 18
Hamburg, 20253
Universitätsklinikum Leipzig, Selbstständige Abteilung für Hämatologie, Internistische Onkologie und Hämostaseologie, Johannisallee 32A
Leipzig, 04103
Johannes Gutenberg Universitaet, I. Medizinische Klinik und Poliklinik, Langenbeckstr. 1
Mainz, 55101
Johannes Gutenberg-Universitaet, III. Medizinische Klinik und Poliklinik, Langenbeckstr. 1
Mainz, 55101
Studienzentrum Mainz-Mitte am GesundheitsCentrum Mainz, Große Langgasse 1A/Eingang Kötherhofstrasse 4
Mainz, 55116
Institut für Tropenmedizin, Wilhelmstraße 27
Tübingen, 72074
Latvia7 sites
Private practice, Berzpils street 14-16
Balvi, 4501
Outpatient clinic " Jelgavas centra doktorats ", Kr. Barona str. 17
Jelgava, 3001
Private practice, Aptiekas maja, Madliena village, Ogres district
Madlienas Parish, 5045
Outpatient clinic "Alma", Kr.Valdemara street 20-4
Riga, 1010
Outpatient clinic "Adoria", Caka street 70-3
Riga, 1011
Outpatient clinic "Veselibas centrs-4", Kr.Barona str. 117
Riga, 1012
Private practice, Slimnicas street 3
Saldus, 3801
Lithuania7 sites
Kaunas 2nd Clinical Hospital, Clinic of Infectious Diseases, Baltijos ave. 120
Kaunas, 47116
Silainiai Family Health Center, Baltu ave. 7a
Kaunas, 48259
Saules Family Medicine Center, Birzelio 23 ios. 4
Kaunas, 50425
Klaipeda University Hospital, Department of Infectious Diseases, Liepojos str. 41
Klaipėda, 92288
Institute of Psychophysiology and Rehabilitation of Kaunas University of Medicine, Vyduno 4
Palanga, 00135
Siauliai District Hospital, Infectious Diseases, Kudirkos 99
Šiauliai, 76231
National Tuberculosis and Infectious Diseases University Hospital, Vilnius University Clinic of Infectious Diseases, Dermatovenereology and Microbiology, Birutes street 1/20
Vilnius, 08117
Netherlands7 sites
Andromed Breda, Middellaan 5
Breda, 4811 VL
Andromed Eindhoven B.V., Bomanshof 6
Eindhoven, 5611 NJ
Andromed Noord B.V., Damsterdiep 9
Groningen, 9711 SG
Andromed Leiden B.V., Doezastraat 1 GZ
Leiden, 2311
Andromed, Kamerlingh Onnestraat 16 -18
Nijmegen, 6533 HL
Andromed Oost B.V., Reigerstraat 30E
Velp, 6883 ES
Andromed Zoetermeer, Parkdreef 142
Zoetermeer, 2724 EK
Belgium5 sites
OLV Hospital Aalst, Research Unit, Moorselbaan 164
Aalst, 9300
Cliniques Universitaires Saint Luc, Avenue Hippocrate 10, Niveau -1 Couloir C11
Brussels, 1200
Center for Vaccinologie, UZ Gent, De Pintelaan 185
Ghent, 9000
UZ Leuven, Kapucijnenvoer 35, Block D, Box 7001
Leuven, 3000
UZ Antwerpen, Universiteitsplein 1
Wilrijk, 2610
Finland5 sites
Espoon rokotetutkimusklinikka, Keskustorni 7. krs., Tapiontori 1
Espoo, 02100
Etelä-Helsingin rokotetutkimusklinikka, Vuorikatu 18, 3 krs
Helsinki, 00100
Tampereen rokotetutkimusklinikka, Pinninkatu 47, 1.krs
Tampere, 33100
Turun rokotetutkimusklinikka, Lemminkäisenkatu 14-18 B, 4.krs
Turku, 20520
Itä-Vantaan rokotetutkimusklinikka, Asematie 11 A 16
Vantaa, 01300
Austria3 sites
Allgemeines Krankenhaus Wien, Innere Medizin, Waehringer Guertel 18-20
Vienna, 1090
Institut für spezifische Prophylaxe und Tropenmedizin, Kinderspitalgasse 15
Vienna, 1090
University Clinic for Clinical Pharmacology, Vienna Medical University / Vienna General Hospital, Waehringer Guertel 18-20
Vienna, 1090
About this study
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
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.
- Conditions
- Influenza
- Being tested
- H5N1 Influenza Vaccine Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvanted
- Keywords
- Influenza (Pandemic)
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H5N1 Influenza Vaccine Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvantedBiological
Intramuscular injection of 7.5 µg hemagglutinin antigen (A/Vietnam/1203/2004 strain) in a non-adjuvanted formulation on Days 0 and 21.
H5N1 Influenza Vaccine Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvantedBiological
Intramuscular injection of 3.75 µg hemagglutinin antigen (A/Vietnam/1203/2004 strain) in a non-adjuvanted formulation on Days 0 and 21.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1, Treatment Arm 1 | Experimental | 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. Receives: Biological: H5N1 Influenza Vaccine Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvanted |
| Cohort 1, Treatment Arm 2 | Experimental | 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. Receives: Biological: H5N1 Influenza Vaccine Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvanted |
| Cohort 1, Treatment Arm 3 | Experimental | 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. Receives: Biological: H5N1 Influenza Vaccine Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvanted |
| Cohort 2, Treatment Arm 1 | Experimental | 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. Receives: Biological: H5N1 Influenza Vaccine Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvanted |
| Cohort 3, Treatment Arm 1 | Experimental | 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. Receives: Biological: H5N1 Influenza Vaccine Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvanted |
| Cohort 1, Treatment Arm 4 | Experimental | 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. Receives: Biological: H5N1 Influenza Vaccine Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvanted |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and severity of systemic reactions until 21 days after the first and second vaccinations
Measured: 42 days
Number of subjects with antibody response to the vaccine strain associated with protection 21 days after the second vaccination defined as titer measured by microneutralization (MN) assay >= 1:20.
Measured: 42 days
Antibody response 21 days after the second vaccination as measured by MN assay;
Measured: 42 days
Secondary outcomes (19)
Frequency and severity of injection site reactions until 21 days after the first and second vaccinations
Measured: 42 days
Number of subjects with fever, malaise or shivering with onset within 7 days after the first and second vaccinations
Measured: 7 days
Frequency and severity of adverse events observed during the entire study period
Measured: 11 months
Number of subjects with antibody response associated with protection 21 days after the first and second vaccinations defined as Hemagglutination Inhibition Antibody (HIA) titer >= 1:40 or Single Radial Hemolysis (SRH) area >= 25 mm2
Measured: 42 days
Number of subjects with antibody response associated with protection 21 days after the second vaccination defined as titer measured by MN assay >=1:40, >= 1:80, >=1:160
Measured: 42 days
Antibody response 21 days after the first and second vaccinations as measured by HI and SRH assays
Measured: 42 days
Fold increase of antibody response 21 days after the first and second vaccinations as compared to baseline as measured by MN, HI and SRH assays
Measured: 42 days
Number of subjects with seroconversion (MN/HI: min.4-fold titer increase vs baseline;SRH:post-vacc. hemolysis area >=25mm2 or increased by >=50% for pre-vacc. sample <=4mm2 and >4mm2, resp., 21 days after 1st and 2nd vaccinations, measured by MN,HI,SRH
Measured: 42 days
Number of subjects with antibody response associated with protection 201 days after the first vaccination as measured by MN, HI and SRH assays
Measured: 201 days
Antibody response 201 days after the first vaccination as measured by MN, HI and SRH assays
Measured: 201 days
Fold increase of antibody response 201 days after the first vaccination as compared to baseline as measured by MN, HI and SRH assays
Measured: 201 days
Number of subjects in the subset included in the assessment of antibody kinetics with antibody response associated with protection 28, 35 and 90 days after the first vaccination as measured by MN, HI and SRH assays
Measured: 90 days
Antibody response in the subset of subjects included in the assessment of antibody kinetics 28, 35 and 90 days after the first vaccination as measured by MN, HI and SRH assays
Measured: 90 days
Fold increase of antibody response in the subset of subjects included in the assessment of antibody kinetics 28, 35 and 90 days after the first vaccination as compared to baseline as measured by MN, HI and SRH assays
Measured: 90 days
Number of subjects in subset for antibody kinetics evaluation with seroconversion (see definitions above) 28, 35, 90 days after 1st vaccination, measured by MN, HI, SRH
Measured: 90 days
T-cell response in the subset of subjects included in the evaluation of cellular immunity after each vaccination as determined by the frequency of cytokine producing T-cells induced by influenza virus antigens
Measured: 201 days
Increase in frequency of cytokine producing T-cells induced by influenza virus antigens after each vaccination as compared to baseline
Measured: 201 days
Number of subjects with antibody response associated with protection 21 days after the first vaccination defined as titer measured by MN assay >=1:20, >=1:40, >=1:80, >=1:160
Measured: 21 days
Antibody response 21 days after the first vaccination as measured by MN assay
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2008 (estimated)
- Study startAug 2008
- Primary completionJul 2009
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,583 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alachua Government Services, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Baxter Bio Science Investigator, Principal investigator, Baxter Healthcare Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00711295
- Sponsor's protocol ID
- 810705
- Status last verified
- Nov 2010
- First submitted
- 2 Jul 2008
- Last updated
- 9 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
van der Velden MV, Geisberger A, Dvorak T, Portsmouth D, Fritz R, Crowe BA, Herr W, Distler E, Wagner EM, Zeitlinger M, Sauermann R, Stephan C, Ehrlich HJ, Barrett PN, Aichinger G. Safety and immunogenicity of a vero cell culture-derived whole-virus H5N1 influenza vaccine in chronically ill and immunocompromised patients. Clin Vaccine Immunol. 2014 Jun;21(6):867-76. doi: 10.1128/CVI.00065-14. Epub 2014 Apr 16.
PubMed 24739978
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00711295
- Acronym / sponsor ID
- 810705
- Conditions
- Influenza
- Keywords
- Influenza (Pandemic)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,583 participants (actual)
- Lead sponsor
- Alachua Government Services, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 8 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1, Treatment Arm 1 | Experimental | Biological: H5N1 Influenza Vaccine Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvantedStratum 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. |
| Cohort 1, Treatment Arm 2 | Experimental | Biological: H5N1 Influenza Vaccine Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvantedStratum 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. |
| Cohort 1, Treatment Arm 3 | Experimental | Biological: H5N1 Influenza Vaccine Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvantedStratum 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. |
| Cohort 2, Treatment Arm 1 | Experimental | Biological: H5N1 Influenza Vaccine Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvanted300 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. |
| Cohort 3, Treatment Arm 1 | Experimental | Biological: H5N1 Influenza Vaccine Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvanted300 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. |
| Cohort 1, Treatment Arm 4 | Experimental | Biological: H5N1 Influenza Vaccine Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvantedStratum 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Are 18 years of age or older on the day of screening;
- Have an understanding of the study and its procedures, agree to its provisions, and give written informed consent prior to study entry;
- Are physically and mentally capable of participating in the study and follow its procedures;
- Agree to keep a daily record of symptoms for the duration of the study;
- If female of childbearing potential - have a negative urine pregnancy test result within 24 hours prior to the scheduled first vaccination and agree to employ adequate birth control measures for the duration of the study.
Key exclusion criteria (24 listed)
- Have a history of exposure to H5N1 virus or a history of vaccination with an H5N1 influenza vaccine;
- Are at high risk of contracting H5N1 influenza infection (e.g. poultry workers);
- Have a history of severe allergic reactions or anaphylaxis;
- Have a rash, dermatological condition or tattoos which may interfere with injection site reaction rating;
- Have donated blood or plasma within 30 days prior to study entry;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| H5N1 Influenza Vaccine Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvantedIntramuscular injection of 7.5 µg hemagglutinin antigen (A/Vietnam/1203/2004 strain) in a non-adjuvanted formulation on Days 0 and 21. | Biological | Cohort 1, Treatment Arm 1, Cohort 1, Treatment Arm 3, Cohort 1, Treatment Arm 4, Cohort 2, Treatment Arm 1, Cohort 3, Treatment Arm 1 |
| H5N1 Influenza Vaccine Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvantedIntramuscular injection of 3.75 µg hemagglutinin antigen (A/Vietnam/1203/2004 strain) in a non-adjuvanted formulation on Days 0 and 21. | Biological | Cohort 1, Treatment Arm 2 |
Primary outcome
Frequency and severity of systemic reactions until 21 days after the first and second vaccinations
Time frame: 42 days
Number of subjects with antibody response to the vaccine strain associated with protection 21 days after the second vaccination defined as titer measured by microneutralization (MN) assay >= 1:20.
Time frame: 42 days
Antibody response 21 days after the second vaccination as measured by MN assay;
Time frame: 42 days
19 secondary outcomes
Frequency and severity of injection site reactions until 21 days after the first and second vaccinations
Time frame: 42 days
Number of subjects with fever, malaise or shivering with onset within 7 days after the first and second vaccinations
Time frame: 7 days
Frequency and severity of adverse events observed during the entire study period
Time frame: 11 months
Number of subjects with antibody response associated with protection 21 days after the first and second vaccinations defined as Hemagglutination Inhibition Antibody (HIA) titer >= 1:40 or Single Radial Hemolysis (SRH) area >= 25 mm2
Time frame: 42 days
Number of subjects with antibody response associated with protection 21 days after the second vaccination defined as titer measured by MN assay >=1:40, >= 1:80, >=1:160
Time frame: 42 days
Antibody response 21 days after the first and second vaccinations as measured by HI and SRH assays
Time frame: 42 days
Fold increase of antibody response 21 days after the first and second vaccinations as compared to baseline as measured by MN, HI and SRH assays
Time frame: 42 days
Number of subjects with seroconversion (MN/HI: min.4-fold titer increase vs baseline;SRH:post-vacc. hemolysis area >=25mm2 or increased by >=50% for pre-vacc. sample <=4mm2 and >4mm2, resp., 21 days after 1st and 2nd vaccinations, measured by MN,HI,SRH
Time frame: 42 days
Number of subjects with antibody response associated with protection 201 days after the first vaccination as measured by MN, HI and SRH assays
Time frame: 201 days
Antibody response 201 days after the first vaccination as measured by MN, HI and SRH assays
Time frame: 201 days
Fold increase of antibody response 201 days after the first vaccination as compared to baseline as measured by MN, HI and SRH assays
Time frame: 201 days
Number of subjects in the subset included in the assessment of antibody kinetics with antibody response associated with protection 28, 35 and 90 days after the first vaccination as measured by MN, HI and SRH assays
Time frame: 90 days
Antibody response in the subset of subjects included in the assessment of antibody kinetics 28, 35 and 90 days after the first vaccination as measured by MN, HI and SRH assays
Time frame: 90 days
Fold increase of antibody response in the subset of subjects included in the assessment of antibody kinetics 28, 35 and 90 days after the first vaccination as compared to baseline as measured by MN, HI and SRH assays
Time frame: 90 days
Number of subjects in subset for antibody kinetics evaluation with seroconversion (see definitions above) 28, 35, 90 days after 1st vaccination, measured by MN, HI, SRH
Time frame: 90 days
T-cell response in the subset of subjects included in the evaluation of cellular immunity after each vaccination as determined by the frequency of cytokine producing T-cells induced by influenza virus antigens
Time frame: 201 days
Increase in frequency of cytokine producing T-cells induced by influenza virus antigens after each vaccination as compared to baseline
Time frame: 201 days
Number of subjects with antibody response associated with protection 21 days after the first vaccination defined as titer measured by MN assay >=1:20, >=1:40, >=1:80, >=1:160
Time frame: 21 days
Antibody response 21 days after the first vaccination as measured by MN assay
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2015.
- Derived from this study: PubMed 24739978van der Velden MV, Geisberger A, Dvorak T, Portsmouth D, Fritz R, Crowe BA, Herr W, Distler E, Wagner EM, Zeitlinger M, Sauermann R, Stephan C, Ehrlich HJ, Barrett PN, Aichinger G. Safety and immunogenicity of a vero cell culture-derived whole-virus H5N1 influenza vaccine in chronically ill and immunocompromised patients. Clin Vaccine Immunol. 2014 Jun;21(6):867-76. doi: 10.1128/CVI.00065-14. Epub 2014 Apr 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Baxter Bio Science Investigator principal investigator
Baxter Healthcare Corporation
45 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing H5N1 Influenza Vaccine Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvanted in people with Influenza, run by Alachua Government Services, Inc. at 45 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in Germany, Latvia, Lithuania, Netherlands, Belgium and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and severity of systemic reactions until 21 days after the first and second vaccinations (time frame: 42 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00711295, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2015.