InfluenzaPhase 4NCT01457027
A Study to Assess Immunogenicity Parameters After Vaccination Against Influenza and to Evaluate How These Parameters Change During the Influenza Season
A Phase 4 study testing Inflexal V in people with Influenza, run by Crucell Holland BV at 1 site in Italy.
Trial summary
A study to evaluate the humoral immune response 3 weeks after vaccination with Inflexal V according to the CHMP criteria in elderly subjects for the 2011/2012 WHO recommended vaccine strains, to evaluate immunogenicity parameters 6 months after vaccination for the 3 vaccine strains and to assess the cross-protection… Read more about this study
- Who is it for?
- Ages 60 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
- 52 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2011to Aug 2012
- Phase
- Phase 4
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy female and male adults aged >60 years on the day of enrollment
- Written informed consent
- Females with confirmed menopause (postmenopausal is defined as 12 months with no menses without an alternative medical cause)
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 for season 2011/2012
- Known hypersensitivity to any vaccine component
- Previous history of a serious adverse reaction to influenza vaccine
- History of egg protein allergy or severe atopy
Show all 14Show fewer
- 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/day prednisolone or equivalent (inhaled or topical steroids are allowed)
- Known immunodeficiency (including leukemia, HIV seropositivity) or 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)
- Participation in another clinical trial
- Employee at the investigational site or relative of the investigator
- Anticipated non-compliance with study procedures
Trial locations and contacts
1 site in 1 country.
Italy1 site
Dept. of Health Sciences, University of Genoa and Hygiene Unit, "San Martino" University Hospital
Genoa, 16100
About this study
Official title: A Phase IV, Open Label Study to Evaluate the Short and Long Term Immune Response and CROSS-protection After Vaccination With viroSOME Adjuvanted Inflexal V in Elderly Subjects
A study to evaluate the humoral immune response 3 weeks after vaccination with Inflexal V according to the CHMP criteria in elderly subjects for the 2011/2012 WHO recommended vaccine strains, to evaluate immunogenicity parameters 6 months after vaccination for the 3 vaccine strains and to assess the cross-protection against 4 selected circulating heterogeneous A/H1N1 influenza strains 3 weeks after influenza vaccination versus baseline.
- Conditions
- Influenza
- Being tested
- Inflexal V
- Keywords
- Influenza, Virus, Vaccination, Immunisation
- 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
Inflexal V influenza vaccine, formulated for the WHO requirements ofr the 2011-2012 season, containing per 0.5 mL dose:
- 15 µg hemagglutinin (HA) antigen of A/California/7/2009 (H1N1)-like virus
- 15 µg HA antigen of A/Perth/16/2009 (H3N2)-like virus
- 15 µg HA antigen of B/Brisbane/60/2008-like virus
Dose: intramuscular administration (M. deltoideus) of a single dose of 0.5 mL on Day 1
| Study group | Role | What they receive |
|---|---|---|
| All subjects | Experimental | Not described Receives: Biological: Inflexal V |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroprotection
Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters will be analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997)
Measured: 3 weeks after vaccination (Day 22 ± 2 days)
Seroconversion
Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters will be analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997)
Measured: 3 weeks after vaccination (Day 22 ± 2 days)
Geometric Mean Titer
GMT of HI antibodies and fold-increase in GMT (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters will be analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997)
Measured: 3 weeks after vaccination (Day 22 ± 2 days)
Secondary outcomes (3)
Geometric Mean Titer
GMT of HI antibodies and fold-increase in GMT (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters will be analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997)
Measured: 6 months post-vaccination
Seroprotection
Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters will be analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997)
Measured: 6 months post-vaccination
Seroconversion
Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters will be analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997)
Measured: 6 months post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionAug 2012
- Study completionAug 2012
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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Crucell Holland BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Giancarlo Icardi, MD, Principal investigator, San Martino University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01457027
- Sponsor's protocol ID
- INF-V-A007
- Status last verified
- Feb 2013
- First submitted
- 20 Oct 2011
- Last updated
- 20 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Open Label Study to Evaluate the Short and Long Term Immune Response and CROSS-protection After Vaccination With viroSOME Adjuvanted Inflexal V in Elderly Subjects
- ClinicalTrials.gov ID
- NCT01457027
- Acronym / sponsor ID
- INF-V-A007
- Conditions
- Influenza
- Keywords
- Influenza, Virus, Vaccination, Immunisation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Crucell Holland BVIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 21 Oct 2011 (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.
A study to evaluate the humoral immune response 3 weeks after vaccination with Inflexal V according to the CHMP criteria in elderly subjects for the 2011/2012 WHO recommended vaccine strains, to evaluate immunogenicity parameters 6 months after vaccination for the 3 vaccine strains and to assess the cross-protection against 4 selected circulating heterogeneous A/H1N1 influenza strains 3 weeks after influenza vaccination versus baseline.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | Experimental | Biological: Inflexal V |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy female and male adults aged >60 years on the day of enrollment
- Written informed consent
- Females with confirmed menopause (postmenopausal is defined as 12 months with no menses without an alternative medical cause)
Key exclusion criteria (14 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 for season 2011/2012
- 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 VInflexal V influenza vaccine, formulated for the WHO requirements ofr the 2011-2012 season, containing per 0.5 mL dose: * 15 µg hemagglutinin (HA) antigen of A/California/7/2009 (H1N1)-like virus * 15 µg HA antigen of A/Perth/16/2009 (H3N2)-like virus * 15 µg HA antigen of B/Brisbane/60/2008-like virus Dose: intramuscular administration (M. deltoideus) of a single dose of 0.5 mL on Day 1 | Biological | All subjects |
Primary outcome
Seroprotection
Time frame: 3 weeks after vaccination (Day 22 ± 2 days)
Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters will be analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997)
Seroconversion
Time frame: 3 weeks after vaccination (Day 22 ± 2 days)
Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters will be analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997)
Geometric Mean Titer
Time frame: 3 weeks after vaccination (Day 22 ± 2 days)
GMT of HI antibodies and fold-increase in GMT (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters will be analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997)
3 secondary outcomes
Geometric Mean Titer
Time frame: 6 months post-vaccination
Seroprotection
Time frame: 6 months post-vaccination
Seroconversion
Time frame: 6 months post-vaccination
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 20 Feb 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.
Giancarlo Icardi, MD principal investigator
San Martino University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Inflexal V in people with Influenza, run by Crucell Holland BV at 1 site in Italy.
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 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 20 Feb 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 Italy. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Seroprotection (time frame: 3 weeks after vaccination (Day 22 ± 2 days)). The study lists 3 primary outcomes in all. 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 20 Feb 2013.