InfluenzaNCT00950456
Observational Study to Assess Safety of H1N1 Pandemic Influenza Vaccine
An observational study of Influenza and Pandemic Influenza, run by Alachua Government Services, Inc. at 17 sites in Austria.
Trial summary
The purpose of this observational study, which will be initiated as soon as the licensed H1N1 Pandemic Influenza Vaccine is used in a mass vaccination campaign, is to estimate the incidence of any medically-attended adverse events in all vaccinated subjects. Read more about this study
- Who is it for?
- Ages 2 months and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza, Pandemic Influenza
- What is being tested?
- H1N1 Pandemic Influenza Vaccine (whole virion, Vero Cell-derived, inactivated)
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 3,216 participants
- Where
- 17 sitesAustria
- Study dates
- Nov 2009to Feb 2011
- Phase
- Observational
- 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 2 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The enrollment of subjects in this study will follow national vaccination policy decisions in the UK.
Who may be able to join
- Male and female subjects, per indication on license or per official vaccine recommendations, will be eligible for participation in this study if:
- They will be administered CELVAPAN (= Baxter´s H1N1 pandemic influenza vaccine)
- They are 2 months of age or older at the time of first vaccine administration
- Their medical history is available
- The investigator believes they will comply with the foreseen vaccination schedule and will reliably observe signs or symptoms of adverse events during the observational period
- They and/or their parent(s)/legal guardian(s) provide written informed consent, and assent where appropriate, prior to study entry according to national law
Who cannot join
- Male and female subjects will be excluded from participation in this study if:
- They have already been administered another H1N1 pandemic vaccine
- They have any contraindication to vaccination (as per the Summary of Product Characteristics and/or relevant national immunization guidelines)
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Austria17 sites
General Practice
Bludenz, 6700
General Practice
Fulpmes, 6166
General Practice
Hall in Tirol, 6060
General Practice
Innsbruck, 6020
Practice for Travel Medicine
Innsbruck, 6020
City Council (Magistrat) Klagenfurt (Health & Food Department)
Klagenfurt, 9020
General Practice
Kufstein, 6330
General Practice
Mariapfarr, 5571
General Practice
Oberperfuss, 6173
General Practice
Salzburg, 5020
General Practice
Telfs, 6410
Medical University of Vienna, Department of Internal Medicine I, Division of Infectious Diseases and Tropical Medicine
Vienna, 1090
Medical University of Vienna, Department of Specific Prophylaxis and Tropical Medicine
Vienna, 1090
Hanusch Hospital
Vienna, 1100
Wiener Gebietskrankenkasse (Health insurance center Vienna)
Vienna, 1100
General Practice
Voitsberg, 8570
General Practice
Wels, 4600
About this study
Official title: A Prospective Non-Interventional Observational Study to Assess the Safety of Two Vaccinations of a Vero Cell-Derived, Whole Virus H1N1 Pandemic Influenza Vaccine in Subjects Exposed to the Vaccine Through Policies by Governments or Health Authorities
The purpose of this observational study, which will be initiated as soon as the licensed H1N1 Pandemic Influenza Vaccine is used in a mass vaccination campaign, is to estimate the incidence of any medically-attended adverse events in all vaccinated subjects.
- Conditions
- Influenza, Pandemic Influenza
- Being tested
- H1N1 Pandemic Influenza Vaccine (whole virion, Vero Cell-derived, inactivated)
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H1N1 Pandemic Influenza Vaccine (whole virion, Vero Cell-derived, inactivated)Biological
Also called CELVAPAN
It is anticipated that subjects will receive two intramuscular injections approximately 3 weeks apart. The vaccine will be provided in two doses, one for adults, the other for children.
| Study group | Role | What they receive |
|---|---|---|
| H1N1 Pandemic Influenza Vaccine | Subjects will be enrolled and vaccinated according to national policy and standard practice. Receives: Biological: H1N1 Pandemic Influenza Vaccine (whole virion, Vero Cell-derived, inactivated) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2009 (estimated)
- Study startNov 2009
- Primary completionDec 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 3,216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alachua Government Services, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Baxter BioScience Medical Director, Study director, Baxter Healthcare Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00950456
- Sponsor's protocol ID
- 820901
- Status last verified
- May 2011
- First submitted
- 30 Jul 2009
- Last updated
- 9 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
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
- A Prospective Non-Interventional Observational Study to Assess the Safety of Two Vaccinations of a Vero Cell-Derived, Whole Virus H1N1 Pandemic Influenza Vaccine in Subjects Exposed to the Vaccine Through Policies by Governments or Health Authorities
- ClinicalTrials.gov ID
- NCT00950456
- Acronym / sponsor ID
- 820901
- Conditions
- Influenza, Pandemic Influenza
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,216 participants (actual)
- Lead sponsor
- Alachua Government Services, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 31 Jul 2009 (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 observational study, which will be initiated as soon as the licensed H1N1 Pandemic Influenza Vaccine is used in a mass vaccination campaign, is to estimate the incidence of any medically-attended adverse events in all vaccinated subjects.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| H1N1 Pandemic Influenza Vaccine | – | Biological: H1N1 Pandemic Influenza Vaccine (whole virion, Vero Cell-derived, inactivated)Subjects will be enrolled and vaccinated according to national policy and standard practice. |
Who may qualify
- Ages
- 2 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The enrollment of subjects in this study will follow national vaccination policy decisions in the UK.
Key inclusion criteria (6 listed)
- Male and female subjects, per indication on license or per official vaccine recommendations, will be eligible for participation in this study if:
- They will be administered CELVAPAN (= Baxter´s H1N1 pandemic influenza vaccine)
- They are 2 months of age or older at the time of first vaccine administration
- Their medical history is available
- The investigator believes they will comply with the foreseen vaccination schedule and will reliably observe signs or symptoms of adverse events during the observational period
Key exclusion criteria (3 listed)
- They have already been administered another H1N1 pandemic vaccine
- They have any contraindication to vaccination (as per the Summary of Product Characteristics and/or relevant national immunization guidelines)
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 |
|---|---|---|
| H1N1 Pandemic Influenza Vaccine (whole virion, Vero Cell-derived, inactivated)Also: CELVAPANIt is anticipated that subjects will receive two intramuscular injections approximately 3 weeks apart. The vaccine will be provided in two doses, one for adults, the other for children. | Biological | H1N1 Pandemic Influenza Vaccine |
Primary outcome
Not reported in the source record.
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.
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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 BioScience Medical Director study director
Baxter Healthcare Corporation
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza and Pandemic Influenza, run by Alachua Government Services, Inc. at 17 sites in Austria.
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 6 inclusion and 3 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 17 sites in Austria. 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.
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.
Where can I read the original study information?
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.