InfluenzaPhase 1/2NCT00289510
Safety and Immunogenicity Study of an Inactivated Influenza Vaccine (Whole Virion, Vero Cell Derived)
A Phase 1/2 study testing Inactivated influenza vaccine (whole virion, Vero cell-derived) in people with Influenza, run by Alachua Government Services, Inc. at 3 sites in 2 countries.
Trial summary
The objective of this study is to assess the safety and immunogenicity of inactivated influenza vaccine (whole virion, Vero cell derived). Subjects will be randomly assigned to receive a single injection of whole virion, Vero cell derived or egg derived influenza vaccine on Day 0. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Inactivated influenza vaccine (whole virion, Vero cell-derived)
- Type of treatment
- Vaccines
- How many people
- 423 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jan 2006to not given
- Phase
- Phase 1/2
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female subjects who
- are 18 to 45 years of age, inclusive, on the day of screening;
- have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry;
- are clinically healthy (in a physical condition such that the physician would have no reservations vaccinating with an influenza vaccine outside the scope of a clinical study);
- agree to keep a daily record of symptoms;
- if female and capable of bearing children - have a negative urine pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study.
Who cannot join
- Subjects who
- have received any influenza vaccination for the 2005/2006 influenza season and/or the 2004/2005 influenza season;
- have received any vaccination within 2 weeks prior to vaccination in this study;
- suffer from any kind of immunodeficiency;
- suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immune response;
- have a history of inflammatory or degenerative neurological disease (e.g. Guillain Barré, multiple sclerosis);
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- have received a blood transfusion or immunoglobulins within 30 days of study entry;
- have donated blood or plasma within 30 days of study entry;
- have a history of any vaccine related contraindicating event (e.g., anaphylaxis, allergy to eggs, allergy to components of the test or comparator vaccine, other known contraindications);
- have a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating;
- have a known or suspected problem with alcohol or drug abuse;
- are unable to lead an independent life as a result of either physical or mental handicap;
- were administered an investigational drug within six weeks prior to study entry;
- are concurrently participating in a clinical study that includes the administration of an investigational product;
- if female, are pregnant or lactating;
- are a member of the team conducting this study or are in a dependent relationship with the study investigator. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Germany2 sites
Klinikum Westend, Haus 18
Berlin, 14050
Internistische Gemeinschaftspraxis Dr. Regner & Dr. Schmitt (Group practice for internal medicine)
Mainz, 55116
Austria1 site
Allgemeines Krankenhaus Wien (General Hospital Vienna)
Vienna, 1090
About this study
Official title: Single-Blind, Randomized, Controlled Phase I/II Study to Compare the Safety and Immunogenicity of an Inactivated Influenza Vaccine (Whole Virion, Vero Cell Derived) With a License Egg Derived Influenza Vaccine
The objective of this study is to assess the safety and immunogenicity of inactivated influenza vaccine (whole virion, Vero cell derived). Subjects will be randomly assigned to receive a single injection of whole virion, Vero cell derived or egg derived influenza vaccine on Day 0. Subjects will return to the study site for safety evaluation at predetermined intervals for 180 days after vaccination. Subjects will also have blood drawn at predetermined intervals to measure their immunologic response to vaccination.
- Conditions
- Influenza
- Being tested
- Inactivated influenza vaccine (whole virion, Vero cell-derived), Inactivated influenza vaccine (egg derived) [licensed control vaccine]
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inactivated influenza vaccine (whole virion, Vero cell-derived)Biological
Inactivated influenza vaccine (egg derived) [licensed control vaccine]Biological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2006 (estimated)
- Study startJan 2006
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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 423 participants
Sponsor and investigators
- Lead sponsor
- Alachua Government Services, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Markus Müller, MD, Principal investigator, Allgemeines Krankenhaus Wien (General Hospital Vienna)Kasra Shakeri-Nejad, MD, Principal investigator, Klinikum Westend, BerlinBernhard Schmitt, MD, Principal investigator, Internistische Gemeinschaftspraxis (Group practice for internal medicine) Dr. Regner & Dr. Schmitt, MainzAlen Jambrecina, MD, Principal investigator, MDS Pharma Services Germany GmbH, HamburgStephan De la Motte, MD, Principal investigator, Harrison Clinical Research / Clinical Unit, Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00289510
- Sponsor's protocol ID
- 710501
- Status last verified
- Oct 2007
- First submitted
- 9 Feb 2006
- Last updated
- 9 Oct 2015
- Results posted
- 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
- Single-Blind, Randomized, Controlled Phase I/II Study to Compare the Safety and Immunogenicity of an Inactivated Influenza Vaccine (Whole Virion, Vero Cell Derived) With a License Egg Derived Influenza Vaccine
- ClinicalTrials.gov ID
- NCT00289510
- Acronym / sponsor ID
- 710501
- Conditions
- Influenza
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 423 participants
- Lead sponsor
- Alachua Government Services, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2006
- First posted
- 10 Feb 2006 (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 objective of this study is to assess the safety and immunogenicity of inactivated influenza vaccine (whole virion, Vero cell derived). Subjects will be randomly assigned to receive a single injection of whole virion, Vero cell derived or egg derived influenza vaccine on Day 0. Subjects will return to the study site for safety evaluation at predetermined intervals for 180 days after vaccination. Subjects will also have blood drawn at predetermined intervals to measure their immunologic response to vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male and female subjects who
- are 18 to 45 years of age, inclusive, on the day of screening;
- have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry;
- are clinically healthy (in a physical condition such that the physician would have no reservations vaccinating with an influenza vaccine outside the scope of a clinical study);
- agree to keep a daily record of symptoms;
Key exclusion criteria (16 listed)
- Subjects who
- have received any influenza vaccination for the 2005/2006 influenza season and/or the 2004/2005 influenza season;
- have received any vaccination within 2 weeks prior to vaccination in this study;
- suffer from any kind of immunodeficiency;
- suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immune response;
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 |
|---|---|---|
| Inactivated influenza vaccine (whole virion, Vero cell-derived) | Biological | – |
| Inactivated influenza vaccine (egg derived) [licensed control vaccine] | Biological | – |
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.
Markus Müller, MD principal investigator
Allgemeines Krankenhaus Wien (General Hospital Vienna)
Kasra Shakeri-Nejad, MD principal investigator
Klinikum Westend, Berlin
Bernhard Schmitt, MD principal investigator
Internistische Gemeinschaftspraxis (Group practice for internal medicine) Dr. Regner & Dr. Schmitt, Mainz
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Inactivated influenza vaccine (whole virion, Vero cell-derived) in people with Influenza, run by Alachua Government Services, Inc. at 3 sites in 2 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 6 inclusion and 16 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 3 sites in Germany, 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
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.