InfluenzaPhase 2/3NCT00161811
Comparison of the Safety and Immune Response of Three Different Lots of an Influenza Vaccine Made by a New Manufacturing Process With a Vaccine Made by the Traditional Manufacturing Process for Season 2004/2005
A Phase 2/3 study testing Vero Cell-derived Influenza Vaccine and Egg cell-derived Influenza Vaccine in people with Influenza, run by Alachua Government Services, Inc. at 4 sites in 2 countries.
Trial summary
The objectives of the study are to assess the immunogenicity and safety among three different lots of the inactivated influenza vaccine (whole virion, Vero cell-derived) at Day 21 and Day 180 after vaccination. 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?
- Vero Cell-derived Influenza Vaccine and Egg cell-derived Influenza Vaccine
- Type of treatment
- Vaccines
- How many people
- 1,400 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Nov 2004to Jul 2005
- Phase
- Phase 2/3
- 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
- Male and female subjects will be eligible for participation in this study if they:
- are >= 18 and <= 60 years old on the day of screening (for Stratum A only);
- are > 60 years old on the day of screening (for Stratum B only);
- 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);
- will reliably keep a daily record of symptoms;
- understand the nature of the study, agree to its provisions, and give written informed consent;
- if female and capable of bearing children - have a negative pregnancy test (urine) result at study entry and agree to employ adequate birth control measures for the duration of the study.
Who cannot join
- Subjects will be excluded from participation in this study if they:
- have received any influenza vaccine for the 2003/2004 season and/or for the 2004/2005 season;
- 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, chemotherapeutics) that can be expected to influence the normal immunologic functions;
- have a history of inflammatory or degenerative neurological disease (e.g. Guillain Barré, multiple sclerosis);
- have received a blood transfusion or immunoglobulins within 30 days of study entry;
Show all 14Show fewer
- have donated blood or plasma within 30 days of study entry;
- have a history of any vaccine-related contraindicating event (e.g. anaphylaxis or other known contraindications);
- have a rash or dermatological condition which may interfere with injection site reaction rating;
- have a known or suspected problem with drug or alcohol abuse;
- are unable to lead an independent life either physically or mentally;
- were administered an investigational drug within six weeks prior to study entry;
- are concurrently participating in a clinical study including the administration of an investigational product;
- if female, are pregnant or lactating.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Germany3 sites
Neuendorfstr. 20
Henningsdorf, 16761
Münstererstr. 1a
Mainz, 55116
Mainz University Children´s Clinic
Mainz, D-55101
Austria1 site
Vienna General Hospital (AKH), Department of Clinical Pharmacology
Vienna, State of Vienna, 1090
About this study
Official title: Single-blind Randomized Controlled Phase II/III Study to Investigate the Immunogenicity and Safety After a Single Vaccination With Three Different Lots of an Inactivated Influenza Vaccine (Whole Virion, Vero Cell-derived) in Comparison to a Licensed Egg Derived Influenza Vaccine for Season 2004/2005.
The objectives of the study are to assess the immunogenicity and safety among three different lots of the inactivated influenza vaccine (whole virion, Vero cell-derived) at Day 21 and Day 180 after vaccination.
- Conditions
- Influenza
- Being tested
- Vero Cell-derived Influenza Vaccine, Egg cell-derived Influenza 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.
Vero Cell-derived Influenza VaccineBiological
Egg cell-derived Influenza VaccineBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2005 (estimated)
- Study startNov 2004
- Study completionJul 2005
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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 1,400 participants
Sponsor and investigators
- Lead sponsor
- Alachua Government Services, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Markus Müller, MD, Principal investigator, Vienna General Hospital (AKH), Department of Clinical PharmacologyPirmin Habermehl, MD, Principal investigator, Mainz University Children´s Clinic, Center for Clinical Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00161811
- Sponsor's protocol ID
- 231
- Other IDs
- EudraCT Number: 2004-001374-34
- Status last verified
- Oct 2006
- First submitted
- 8 Sep 2005
- 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 II/III Study to Investigate the Immunogenicity and Safety After a Single Vaccination With Three Different Lots of an Inactivated Influenza Vaccine (Whole Virion, Vero Cell-derived) in Comparison to a Licensed Egg Derived Influenza Vaccine for Season 2004/2005.
- ClinicalTrials.gov ID
- NCT00161811
- Acronym / sponsor ID
- 231
- Conditions
- Influenza
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,400 participants
- Lead sponsor
- Alachua Government Services, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2004
- Study completion
- Jul 2005
- First posted
- 13 Sep 2005 (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 objectives of the study are to assess the immunogenicity and safety among three different lots of the inactivated influenza vaccine (whole virion, Vero cell-derived) at Day 21 and Day 180 after vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- are >= 18 and <= 60 years old on the day of screening (for Stratum A only);
- are > 60 years old on the day of screening (for Stratum B only);
- 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);
- will reliably keep a daily record of symptoms;
- understand the nature of the study, agree to its provisions, and give written informed consent;
Key exclusion criteria (14 listed)
- have received any influenza vaccine for the 2003/2004 season and/or for the 2004/2005 season;
- 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, chemotherapeutics) that can be expected to influence the normal immunologic functions;
- have a history of inflammatory or degenerative neurological disease (e.g. Guillain Barré, multiple sclerosis);
- have received a blood transfusion or immunoglobulins within 30 days 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 |
|---|---|---|
| Vero Cell-derived Influenza Vaccine | Biological | – |
| Egg cell-derived Influenza 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
Vienna General Hospital (AKH), Department of Clinical Pharmacology
Pirmin Habermehl, MD principal investigator
Mainz University Children´s Clinic, Center for Clinical Studies
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Vero Cell-derived Influenza Vaccine and Egg cell-derived Influenza Vaccine in people with Influenza, run by Alachua Government Services, Inc. at 4 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 7 inclusion and 14 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 4 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
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.