InfluenzaPhase 3NCT00354016
Safety and Immunogenicity of Preservative Free Inactivated Split Influenza Vaccine, Using the Strain Composition 2006/2007 in Non-Elderly Adult and Elderly Subjects
A Phase 3 study testing preservative free inactivated split influenza vaccine using the strain composition 2006/2007 in people with Influenza, run by Novartis at 2 sites in Germany.
Trial summary
Due to antigenic changes of influenza viruses, the virus strains used in influenza vaccines are adjusted every year according to WHO (World Health Organization) and CHMP (Committee for Medicinal Products for Human Use) recommendations. 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?
- preservative free inactivated split influenza vaccine using the strain composition 2006/2007
- Type of treatment
- Vaccines
- How many people
- 125 participants
- Where
- 2 sitesGermany
- Study dates
- Jul 2006to not given
- 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
- Healthy adults aged >18 years
Who cannot join
- serious chronic diseases or significant acute infections requiring systemic antibiotic treatment
- history of any anaphylaxis, serious vaccine reactions
- hypersensitivity against vaccine components
- history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
- known or suspected impairment/alteration of immune function
- more than one injection of influenza vaccine received or laboratory confirmed influenza disease
- within last 6 months: influenza vaccination received
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Werksarztzentrum Herborn, Westerwaldstr 36,
Herborn, 35745
Betriebsarztlicher Dienst, Universitat Marburg, Robert-Koch-Str, 5,
Marburg, 35037
About this study
Official title: A Phase III, Multicenter, Uncontrolled, Open-Label Study to Demonstrate Safety and Immunogenicity of a Commercially Available Preservative Free Inactivated Split Influenza Vaccine, Using the Strain Composition 2006/2007 When Administered to Non-Elderly Adult and Elderly Subjects
Due to antigenic changes of influenza viruses, the virus strains used in influenza vaccines are adjusted every year according to WHO (World Health Organization) and CHMP (Committee for Medicinal Products for Human Use) recommendations. Immunogenicity and tolerability of the newly composed vaccines are subject for evaluation in a yearly clinical trial in non-elderly and elderly subjects (CPMP/BWP/214/96).
- Conditions
- Influenza
- Being tested
- preservative free inactivated split influenza vaccine using the strain composition 2006/2007
- Keywords
- 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.
preservative free inactivated split influenza vaccine using the strain composition 2006/2007Biological
What is being measured
The primary outcome is the main question the study is designed to answer.
antibody titers to each influenza strain measured by hemagglutination inhibition (HI) test on Day 0 and on Day 21
Secondary outcomes (1)
safety of a single IM dose of the split influenza vaccine using solicited local and systemic reactions and adverse event reporting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2006 (estimated)
- Study startJul 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 3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novartis Vaccines
- Investigators
- Novartis Vaccines - Drug Information Services, Study chair, Novartis Vaccines & Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00354016
- Sponsor's protocol ID
- V44P10S
- Other IDs
- EudraCT number 2006-000438-11
- Status last verified
- Mar 2007
- First submitted
- 18 Jul 2006
- Last updated
- 13 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Uncontrolled, Open-Label Study to Demonstrate Safety and Immunogenicity of a Commercially Available Preservative Free Inactivated Split Influenza Vaccine, Using the Strain Composition 2006/2007 When Administered to Non-Elderly Adult and Elderly Subjects
- ClinicalTrials.gov ID
- NCT00354016
- Acronym / sponsor ID
- V44P10S
- Conditions
- Influenza
- Keywords
- influenza, vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Collaborators
- Novartis Vaccines
- Study start
- Jul 2006
- First posted
- 19 Jul 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.
Due to antigenic changes of influenza viruses, the virus strains used in influenza vaccines are adjusted every year according to WHO (World Health Organization) and CHMP (Committee for Medicinal Products for Human Use) recommendations. Immunogenicity and tolerability of the newly composed vaccines are subject for evaluation in a yearly clinical trial in non-elderly and elderly subjects (CPMP/BWP/214/96).
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 (1 listed)
- Healthy adults aged >18 years
Key exclusion criteria (7 listed)
- serious chronic diseases or significant acute infections requiring systemic antibiotic treatment
- history of any anaphylaxis, serious vaccine reactions
- hypersensitivity against vaccine components
- history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
- known or suspected impairment/alteration of immune function
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 |
|---|---|---|
| preservative free inactivated split influenza vaccine using the strain composition 2006/2007 | Biological | – |
Primary outcome
antibody titers to each influenza strain measured by hemagglutination inhibition (HI) test on Day 0 and on Day 21
1 secondary outcome
safety of a single IM dose of the split influenza vaccine using solicited local and systemic reactions and adverse event reporting
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 13 Mar 2007.
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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.
Novartis Vaccines - Drug Information Services study chair
Novartis Vaccines & Diagnostics
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing preservative free inactivated split influenza vaccine using the strain composition 2006/2007 in people with Influenza, run by Novartis at 2 sites in Germany.
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 1 inclusion and 7 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 13 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
antibody titers to each influenza strain measured by hemagglutination inhibition (HI) test on Day 0 and on Day 21. 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 13 Mar 2007.