InfluenzaPhase 3NCT01893177
Re-licensing Study to Assess Inflexal V Formulated With WHO Recommended Influenza Strains (2013-14)
A Phase 3 study testing Inflexal V in people with Influenza, run by Crucell Holland BV at 1 site in Switzerland.
Trial summary
The study is to assess whether the influenza vaccine Inflexal V for season 2013/2014 fulfills the EMA requirements for re-registration of influenza vaccines. 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?
- Inflexal V
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2013to Aug 2013
- 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 female and male adults aged ≥18 on Day 1
- Written informed consent
- Female subjects of childbearing potential using and willing to continue using an acceptable method of contraception unless surgically sterilized/hysterectomized or post-menopausal for more than 2 years
Who cannot join
- Acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or other acute disease
- Acute febrile illness (≥38.0 °C)
- Prior vaccination with an influenza vaccine in the past 330 days
- Known hypersensitivity to any vaccine component
- Previous history of a serious adverse reaction to influenza vaccine
- History of egg protein allergy or severe atopy
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- Known blood coagulation disorder
- Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of the study vaccine, including oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent (inhaled or topical steroids are allowed)
- Known immunodeficiency (incl. leukemia, HIV seropositivity), cancer
- Investigational medicinal product received in the past 3 months (90 days)
- Treatment with immunoglobulins or blood transfusion(s) received in the past 3 months (90 days)
- Pregnancy or lactation
- Participation in another clinical trial
- Employee at the investigational site, or relative of the investigator
- Subjects who in the view of the investigator will not comply with study procedures and/or visit requirements as per protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open, Non-randomized Trial to Assess the Immunogenicity and Safety of the 2013/2014-season Virosomal Subunit Influenza Vaccine in Elderly and Young Subjects According to EMA Regulations
The study is to assess whether the influenza vaccine Inflexal V for season 2013/2014 fulfills the EMA requirements for re-registration of influenza vaccines.
- Conditions
- Influenza
- Being tested
- Inflexal V
- Keywords
- Influenza, Virus, Vaccination, Inflexal V
- Medical subject headings
- Influenza, Human, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inflexal VBiological
Also called Inflexal V influenza vaccine (surface antigen, inactivated, virosome) formulated for the WHO requirements of the 2013-2014 season, each 0.5 mL dose containing:, • 15 µg HA antigen of A/California/7/2009 (H1N1)-like virus, • 15 µg HA antigen of A/Texas/50/2012 (H3N2)-like virus, • 15 µg HA antigen of B/Massachusetts/2/2012-like virus
Intramuscular administration (M. deltoideus) of a single dose of 0.5 mL Inflexal V
| Study group | Role | What they receive |
|---|---|---|
| Elderly subjects aged over 60 years | Experimental | Not described Receives: Biological: Inflexal V |
| Adults from 18 to 60 years old inclusive | Experimental | Not described Receives: Biological: Inflexal V |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with seroconversion, seroprotection, and fold increase in geometric mean titer (GMT)
Immunogenicity variables are analyzed according to the EMA re-licensing criteria; at least one of the criteria has to be fulfilled for each vaccine strain:
- Seroconversion rate at Day 22 has to be >40% of subjects aged ≥18 to ≤60 years and >30% of subjects aged >60 years, or
- Seroprotection rate at Day 22 has to be >70% of subjects aged ≥18 to ≤60 years and >60% of subjects aged >60 years, or
- GMT-fold increase at Day 22 compared to baseline: a >2.5-fold increase has to be reached in subjects aged ≥18 to ≤60 years and a >2.0-fold increase has to be reached in subjects aged >60 years
Measured: Day 22 +/- 2 days
Secondary outcomes (3)
Incidence of solicited local adverse events
Measured: Days 1 to 4 inclusive
Incidence of solicited systemic adverse events
Measured: Days 1 to 4 inclusive
Incidence of unsolicited adverse events
Measured: Days 1 to 22 inclusive
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionAug 2013
- Study completionAug 2013
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Crucell Holland BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Milko Radicioni, MD, Principal investigator, Cross Research S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01893177
- Sponsor's protocol ID
- INF-V-A018
- Status last verified
- Aug 2013
- First submitted
- 2 Jul 2013
- Last updated
- 30 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Non-randomized Trial to Assess the Immunogenicity and Safety of the 2013/2014-season Virosomal Subunit Influenza Vaccine in Elderly and Young Subjects According to EMA Regulations
- ClinicalTrials.gov ID
- NCT01893177
- Acronym / sponsor ID
- INF-V-A018
- Conditions
- Influenza
- Keywords
- Influenza, Virus, Vaccination, Inflexal V
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Crucell Holland BVIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 8 Jul 2013 (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 study is to assess whether the influenza vaccine Inflexal V for season 2013/2014 fulfills the EMA requirements for re-registration of influenza vaccines.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elderly subjects aged over 60 years | Experimental | Biological: Inflexal V |
| Adults from 18 to 60 years old inclusive | Experimental | Biological: Inflexal V |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy female and male adults aged ≥18 on Day 1
- Written informed consent
- Female subjects of childbearing potential using and willing to continue using an acceptable method of contraception unless surgically sterilized/hysterectomized or post-menopausal for more than 2 years
Key exclusion criteria (15 listed)
- Acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or other acute disease
- Acute febrile illness (≥38.0 °C)
- Prior vaccination with an influenza vaccine in the past 330 days
- Known hypersensitivity to any vaccine component
- Previous history of a serious adverse reaction to influenza vaccine
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 |
|---|---|---|
| Inflexal VAlso: Inflexal V influenza vaccine (surface antigen, inactivated, virosome) formulated for the WHO requirements of the 2013-2014 season, each 0.5 mL dose containing:, • 15 µg HA antigen of A/California/7/2009 (H1N1)-like virus, • 15 µg HA antigen of A/Texas/50/2012 (H3N2)-like virus, • 15 µg HA antigen of B/Massachusetts/2/2012-like virusIntramuscular administration (M. deltoideus) of a single dose of 0.5 mL Inflexal V | Biological | Adults from 18 to 60 years old inclusive, Elderly subjects aged over 60 years |
Primary outcome
Percentage of subjects with seroconversion, seroprotection, and fold increase in geometric mean titer (GMT)
Time frame: Day 22 +/- 2 days
Immunogenicity variables are analyzed according to the EMA re-licensing criteria; at least one of the criteria has to be fulfilled for each vaccine strain: * Seroconversion rate at Day 22 has to be >40% of subjects aged ≥18 to ≤60 years and >30% of subjects aged >60 years, or * Seroprotection rate at Day 22 has to be >70% of subjects aged ≥18 to ≤60 years and >60% of subjects aged >60 years, or * GMT-fold increase at Day 22 compared to baseline: a >2.5-fold increase has to be reached in subjects aged ≥18 to ≤60 years and a >2.0-fold increase has to be reached in subjects aged >60 years
3 secondary outcomes
Incidence of solicited local adverse events
Time frame: Days 1 to 4 inclusive
Incidence of solicited systemic adverse events
Time frame: Days 1 to 4 inclusive
Incidence of unsolicited adverse events
Time frame: Days 1 to 22 inclusive
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 30 Aug 2013.
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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.
Milko Radicioni, MD principal investigator
Cross Research S.A.
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 Inflexal V in people with Influenza, run by Crucell Holland BV at 1 site in Switzerland.
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 3 inclusion and 15 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 30 Aug 2013. 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 Switzerland. 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?
Percentage of subjects with seroconversion, seroprotection, and fold increase in geometric mean titer (GMT) (time frame: Day 22 +/- 2 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 30 Aug 2013.