InfluenzaPhase 3NCT00943657
Yearly Strain Variation Study, 2009/2010
A Phase 3 study testing Preflucel [Trivalent seasonal influenza vaccine (split virus, Vero cell-derived)] in people with Influenza and Seasonal Influenza, run by Alachua Government Services, Inc. at 1 site in Austria.
Trial summary
The purpose of this study is to verify the immunogenicity and tolerance of a trivalent seasonal influenza vaccine with strain composition according to World Heath Organization/European Union (WHO/EU) recommendation for the 2009/2010 season for yearly licensing application. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza, Seasonal Influenza
- What is being tested?
- Preflucel [Trivalent seasonal influenza vaccine (split virus, Vero cell-derived)]
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 110 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2009to Jul 2009
- 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
- Subject is 18 to 59 years of age , inclusive, at the time of screening (for subjects in age stratum A only)
- Subject is 60 years of age or older , inclusive, at the time of screening (for subjects in age stratum B only)
- Subject has given written informed consent prior to study entry
- Subject is generally healthy , as determined by the investigator's clinical judgment through collection of medical history and performance of a physical examination, such that the investigator would not hesitate to provide routine influenza immunization to the subject in the course of routine medical practice
- Subject agrees to keep a daily record of symptoms for the duration of the study
- If female of childbearing potential, subject presents with a negative urine pregnancy test, and agrees to employ adequate birth control measures for the duration of the study
- Subject is willing and able to comply with the requirements of the protocol
Who cannot join
- Subject has a history of severe allergic reaction or anaphylaxis
- Subject has an oral temperature of >= 37.5°C on the day of vaccination in this study
- Subject has a rash or dermatologic condition or tattoos, which may interfere with injection site reaction rating
- Subject has received a live vaccine within 4 weeks or an inactivated or subunit vaccine within 2 weeks of study entry
- Subject has received a seasonal influenza vaccine within 6 months of study entry
- Subject currently has or had a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder
Show all 12Show fewer
- Subject has any inherited or acquired immunodeficiency
- Subject has a disease or is currently undergoing a form of treatment or was 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 (>800 µg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs.
- Subject has a functional or surgical asplenia
- Subject has a known or suspected problem with alcohol or drug abuse
- Subject is a member of the team conducting this study or is in a dependent relationship with one of the study team members. Dependent relationships include close relatives (ie, children, partner/spouse, siblings, parents) as well as employees of the investigator or site personnel conducting the study
- If female, subject is pregnant or lactating at the time of study enrollment
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Vienna, Department of Clinical Pharmacology
Vienna, 1090
About this study
Official title: An Open-Label Phase 3 Study to Assess the Immunogenicity and Safety of a Vero Cell-Derived Trivalent Seasonal Influenza Vaccine, Strain Composition 2009/2010, in an Adult and Elderly Population
The purpose of this study is to verify the immunogenicity and tolerance of a trivalent seasonal influenza vaccine with strain composition according to World Heath Organization/European Union (WHO/EU) recommendation for the 2009/2010 season for yearly licensing application.
- Conditions
- Influenza, Seasonal Influenza
- Being tested
- Preflucel [Trivalent seasonal influenza vaccine (split virus, Vero cell-derived)]
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preflucel [Trivalent seasonal influenza vaccine (split virus, Vero cell-derived)]Biological
Also called Preflucel
Single intramuscular injection of vaccine
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects demonstrating seroconversion to each of the three antigens contained in the vaccine 21 days after vaccination
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 posted22 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionJul 2009
- Study completionJul 2009
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alachua Government Services, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00943657
- Sponsor's protocol ID
- 720901
- Status last verified
- Oct 2009
- First submitted
- 21 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
- An Open-Label Phase 3 Study to Assess the Immunogenicity and Safety of a Vero Cell-Derived Trivalent Seasonal Influenza Vaccine, Strain Composition 2009/2010, in an Adult and Elderly Population
- ClinicalTrials.gov ID
- NCT00943657
- Acronym / sponsor ID
- 720901
- Conditions
- Influenza, Seasonal Influenza
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Alachua Government Services, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 22 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 study is to verify the immunogenicity and tolerance of a trivalent seasonal influenza vaccine with strain composition according to World Heath Organization/European Union (WHO/EU) recommendation for the 2009/2010 season for yearly licensing application.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject is 18 to 59 years of age , inclusive, at the time of screening (for subjects in age stratum A only)
- Subject is 60 years of age or older , inclusive, at the time of screening (for subjects in age stratum B only)
- Subject has given written informed consent prior to study entry
- Subject is generally healthy , as determined by the investigator's clinical judgment through collection of medical history and performance of a physical examination, such that the investigator would not hesitate to provide routine influenza immunization to the subject in the course of routine medical practice
- Subject agrees to keep a daily record of symptoms for the duration of the study
Key exclusion criteria (12 listed)
- Subject has a history of severe allergic reaction or anaphylaxis
- Subject has an oral temperature of >= 37.5°C on the day of vaccination in this study
- Subject has a rash or dermatologic condition or tattoos, which may interfere with injection site reaction rating
- Subject has received a live vaccine within 4 weeks or an inactivated or subunit vaccine within 2 weeks of study entry
- Subject has received a seasonal influenza vaccine within 6 months of 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 |
|---|---|---|
| Preflucel [Trivalent seasonal influenza vaccine (split virus, Vero cell-derived)]Also: PreflucelSingle intramuscular injection of vaccine | Biological | – |
Primary outcome
Number of subjects demonstrating seroconversion to each of the three antigens contained in the vaccine 21 days after vaccination
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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Preflucel [Trivalent seasonal influenza vaccine (split virus, Vero cell-derived)] in people with Influenza and Seasonal Influenza, run by Alachua Government Services, Inc. at 1 site 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 7 inclusion and 12 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 1 site 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.
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?
Number of subjects demonstrating seroconversion to each of the three antigens contained in the vaccine 21 days after vaccination (time frame: 21 days). It is what the study was designed to measure, not a finding.
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.